Cord Blood Infusion for Children With Autism Spectrum Disorder (Duke ACT)

• ClinicalTrials.gov Identifier: NCT02847182
• Recruitment Status: Completed
• First Posted: July 28, 2016
• Results First Posted: December 26, 2019
• Last Update Posted: June 9, 2020
• Sponsor: Joanne Kurtzberg, MD
• Information provided by (Responsible Party): Joanne Kurtzberg, MD, Duke University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Autism Spectrum Disorder; ASD; Autism; PDD
• Interventions: Biological: Cord Blood Infusion; Biological: Placebo
• Enrollment: 180

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cord Blood Infusion, Then Placebo Infusion	Placebo Infusion, Then Cord Blood Infusion
Arm/Group Description	Subjects will be randomized to receive a cord blood infusion at the baseline visit, followed by a placebo infusion at 6 months. The cord blood will be autologous (if available) or unrelated cord blood. The placebo is an acellular media product similar in both appearance and odor. Cord Blood Infusion Placebo	Subjects will be randomized to receive a placebo infusion at the baseline visit, followed by a cord blood infusion at 6 months. The placebo is an acellular media product similar in both appearance and odor. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion Placebo
Period Title: Overall Study
Started	119	61
First Intervention (6 Months)	119	61
Second Intervention (6 Months)	61	119
Completed	119	60
Not Completed	0	1
Reason Not Completed
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		Cord Blood Infusion, Then Placebo Infusion	Placebo Infusion, Then Cord Blood Infusion	Total
Arm/Group Description		Subjects will be randomized to receive a cord blood infusion at the baseline visit, followed by a placebo infusion at 6 months. The cord blood will be autologous (if available) or unrelated cord blood. The placebo is an acellular media product similar in both appearance and odor. Cord Blood Infusion Placebo	Subjects will be randomized to receive a placebo infusion at the baseline visit, followed by a cord blood infusion at 6 months. The placebo is an acellular media product similar in both appearance and odor. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion Placebo	Total of all reporting groups
Overall Number of Baseline Participants		119	61	180
Baseline Analysis Population Description		The protocol-specified pilot subjects, both randomized to placebo, were also mistakenly enrolled several days after their 8th birthday, in violation of the age-related inclusion criteria.
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	119 participants	61 participants	180 participants
		5.30; (2.39 to 8.00)	5.24; (2.31 to 8.13)	5.29; (2.31 to 8.13)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	119 participants	61 participants	180 participants
	Female	21 17.6%	16 26.2%	37 20.6%
	Male	98 82.4%	45 73.8%	143 79.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	119 participants	61 participants	180 participants
	Hispanic or Latino	26 21.8%	6 9.8%	32 17.8%
	Not Hispanic or Latino	93 78.2%	55 90.2%	148 82.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	119 participants	61 participants	180 participants
	Non-White	24 20.2%	17 27.9%	41 22.8%
	White	95 79.8%	44 72.1%	139 77.2%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	119 participants	61 participants	180 participants
		119 100.0%	61 100.0%	180 100.0%

Outcome Measures

1. Primary Outcome

Title	Change in Social Communication as Measured by the Vineland Adaptive Behavior Scales, Third Edition (VABS-3)
Description	The Vineland Adaptive Behavior Scales, Third Edition (VABS-3) Socialization domain standard score has mean=100 and standard deviation=15 (range: 20-140). Higher scores indicate better developed adaptive social behavior. The change in the Socialization domain standard score was calculated for each participant from Baseline to Month 6. Changes in the Socialization standard score are indicative of skill acquisition relative to chronologically aged peers of the same sex. Thus, a zero (no change) represents change consistent with what is expected. An increase represents acquisition of more skills over time than would be expected. Participants who experience a decrease in Socialization standard score may still have acquired skills although not at the rate expected based on their age and sex.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: score on a scale
	3.13 (8.76)	1.98 (8.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cord Blood Infusion - 6 Months, Placebo Infusion - 6 Months
	Comments	Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.83
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.14
	Confidence Interval	(2-Sided) 95%; -1.58 to 3.86
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change in Vineland Socialization Domain Raw Score
Description	There are 3 raw scores within the Socialization domain of the VABS-3. These are the Interpersonal Relationships Raw Score (range: 0-86), the Play and Leisure Raw Score (range: 0-72), and the Coping Skills Raw Score (range: 0-66). Higher numbers on all three scores reflect better functioning in each area. Each raw score is the sum of the item scores in the respective subdomain of Socialization skills. The items are scored as follows: 2=usually present, 1=sometimes present, 0= never present. The item scores are assigned by a trained interviewer who interviews the parent of the child participating in the study. The change in raw score was calculated for each participant from Baseline to Month 6. Positive scores indicate improvement over time whereas negative scores indicate worsening, and zero indicates no change. The scores are not norm-referenced.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: score on a scale
Interpersonal Relationships Raw Score	5.40 (9.13)	4.11 (9.42)
Play and Leisure Raw Score	4.76 (9.84)	3.09 (7.68)
Coping Skills Raw Score	3.82 (7.54)	2.91 (7.21)

3. Secondary Outcome

Title	Change in Vineland Socialization Domain Age Equivalent
Description	There are 3 age equivalent scores within the Socialization domain of the VABS-3: the Interpersonal Relationships Age Equivalent, the Play and Leisure Age Equivalent, and the Coping Sills Age Equivalent. An individual participant's age equivalent represents the chronological age (in years:months) at which their score would be considered normative. The age equivalent ranges are 0:0-22:0, 0:0-20:0, and 2:0-22:0 for the Interpersonal Relationships, Play and Leisure and Coping Skills age equivalents, respectively. The change in this age equivalent was calculated for each participant from Baseline to Month 6 and expressed as a number of months. Positive scores indicate increases in the age equivalent of the participant's social communication skills over time and are considered an improvement. Negative scores indicate decreases in the age equivalent of the participant's social communication skills and are considered worsening, and zero indicates no change.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: months
Interpersonal Relationships Age Equivalent Score	0.37 (0.72)	0.19 (0.79)
Play and Leisure Age Equivalent Score	0.41 (1.17)	0.30 (1.21)
Coping Skills Age Equivalent Score	0.26 (0.77)	0.18 (0.89)

4. Secondary Outcome

Title	Change in Pervasive Developmental Disorder Behavior Inventory (PDD-BI) Composite Standard Score (Parent Questionnaire)
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The PDD-BI assesses both social impairments and development of pro-social skills that are integral to improved reciprocal social behavior. The PDD-BI renders T scores (mean=50, standard deviation=10) based on comparisons to a standardized ASD population. The Autism Composite T score ranges from 10-100. The typical child with autism scores between 40-60.Higher scores indicate more severe autism symptoms and lower scores reflect milder symptoms. Change in this score from Baseline to Month 6 was calculated for each participant. Negative change scores indicate improvement in autism symptoms over time whereas positive scores indicate worsening of symptoms, and zero indicates no change in symptoms.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: score on a scale
	-6.65 (10.44)	-6.12 (8.82)

5. Secondary Outcome

Title	Change in Clinical Global Impressions - Severity of Illness (CGI-S) Score, Clinician Assessment
Description	The CGI-S is a 7 point scale completed at the baseline and 6-month visits that requires the clinician to rate the severity of the participant's symptoms of autism at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. There are 3 CGI-S scores: the Social Communication Score, the Restricted and Repetitive Behaviors Score, and the Overall Score. The clinician's rates the severity of autism symptoms - 1, normal, no symptoms; 2, borderline level of symptoms; 3, mild symptoms; 4, moderate symptoms; 5, marked symptoms; 6, severe symptoms; or 7, extremely severe symptoms. Increases in the change score represent increases in symptom severity, decreases in the change score indicate improvement, and zero indicates no change.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment. Two additional subjects were excluded from the Cord Blood group because they were missing assessments.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	117	57
Mean (Standard Deviation); Unit of Measure: score on a scale
Social Communication Score	-0.11 (0.58)	-0.19 (0.52)
Restricted, Repetitive Behaviors Score	-0.25 (0.73)	-0.18 (0.73)
Overall Score	-0.15 (0.57)	-0.26 (0.58)

6. Secondary Outcome

Title	Clinical Global Impressions - Global Improvement (CGI-I) Score, Clinician Assessment
Description	The CGI-I is a 7 point scale that requires the clinician to assess how much the participant's autism symptoms have improved or worsened relative to a baseline assessment. The symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. There are three separate CGI-I ratings: social communicative functioning, restricted/repetitive interests and behaviors, and overall improvement.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment. Two additional subjects were excluded from the Cord Blood group because they were missing assessments.

Arm/Group Title		Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:		Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed		117	57
Measure Type: Count of Participants; Unit of Measure: Participants
Social Communicative Functioning	1=Very Much Improved	0 0.0%	0 0.0%
	2=Much Improved	26 22.2%	9 15.8%
	3=Minimally Improved	30 25.6%	16 28.1%
	4=No Change	58 49.6%	31 54.4%
	5=Minimally Worse	3 2.6%	1 1.8%
	6=Much Worse	0 0.0%	0 0.0%
Restricted/repetitive Interests and Behaviors	1=Very Much Improved	1 0.9%	0 0.0%
	2=Much Improved	17 14.5%	11 19.3%
	3=Minimally Improved	29 24.8%	10 17.5%
	4=No Change	59 50.4%	29 50.9%
	5=Minimally Worse	10 8.5%	7 12.3%
	6=Much Worse	1 0.9%	0 0.0%
Overall Score	1=Very Much Improved	1 0.9%	0 0.0%
	2=Much Improved	26 22.2%	11 19.3%
	3=Minimally Improved	37 31.6%	18 31.6%
	4=No Change	47 40.2%	27 47.4%
	5=Minimally Worse	6 5.1%	1 1.8%
	6=Much Worse	0 0.0%	0 0.0%

7. Secondary Outcome

Title	Change in Expressive One-Word Picture Vocabulary Test (Clinician Assessment)
Description	This Expressive One-Word Picture Vocabulary Test is a standardized evaluation of the child's expressive one-word vocabulary by a trained clinician. It tests an individual's ability to name, with one word, objects, actions, and concepts when presented with color illustrations. Higher EOWPVT standard scores reflect a better vocabulary. The minimum score is age-dependent (years:months) as follows. For a child age 2:0 to 2:1 the minimum is 65; age 2:2-2:3 (min=62); age 2:4-2:5 (min=60); age 2:6-2:7 (min=58); age 2:8-2:9 (min=57); age 2:10-2:11 (min=56); age 3:0 and older (min=55). The maximum possible score across all ages is 145. The change in score from Baseline to Month 6 was the outcome measure. Increases reflect increases in vocabulary skills, decreasing reflect decreases in vocabulary skills, and zero reflects no change.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment. Three additional subjects were excluded from the Cord Blood group because they were missing assessments.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	116	57
Mean (Standard Deviation); Unit of Measure: score on a scale
	0.89 (7.48)	1.88 (10.18)

8. Secondary Outcome

Title	Change in Vineland Adaptive Behavior Scales II (VABS-II) Communication Subscale Standard Score
Description	The VABS-II measures adaptive functioning in socialization, communication, daily living, and motor skills. The Communication subscale standard score is derived by summing norm-referenced (by age group and sex) v-scale scores (mean=15, standard deviation=3) from the Receptive, Expressive, and Written communication subdomains and standardizing this sum to a normal distribution with mean=100 and standard deviation=15. Changes in the Communication standard score are indicative of skill acquisition relative to chronologically aged peers of the same sex. Thus, a zero (no change) represents change consistent with what is expected. An increase represents acquisition of more skills over time than would be expected. Participants who experience a decrease in Communication standard score may still have acquired skills although not at the rate expected based on their age and sex.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: score on a scale
	2.87 (8.95)	2.81 (9.68)

9. Secondary Outcome

Title	Change in Vineland Adaptive Behavior Scales II (VABS-II) Daily Living Subscale Standard Score
Description	The VABS-II measures adaptive functioning in socialization, communication, daily living, and motor skills. The Daily Living standard score is derived by summing norm-referenced (by age group and sex) v-scale scores (mean=15, standard deviation=3) from the Personal, Domestic and Community subdomains and standardizing this sum to a normal distribution with mean=100 and standard deviation=15. Changes in the Daily Living standard score are indicative of skill acquisition relative to chronologically aged peers of the same sex. Thus, a zero (no change) represents change consistent with what is expected. An increase represents acquisition of more skills over time than would be expected. Participants who experience a decrease in Daily Living standard score may still have acquired skills although not at the rate expected based on their age and sex.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: score on a scale
	2.21 (6.89)	2.49 (7.41)

10. Secondary Outcome

Title	Change in Vineland Adaptive Behavior Scales II (VABS-II) Composite Score
Description	The Vineland Adaptive Behavior Scales II (VABS-II) measures adaptive functioning in socialization, communication, daily living, and motor skills. The Adaptive Behavior Composite provides an overall summary of adaptive behavior across all of the domains. Each participant's score is standardized to a normal distribution with mean=100 and standard deviation=15. Positive scores indicate an increase in the Adaptive Behavior Composite Score over time whereas negative scores indicate decrease in the Adaptive Behavior Composite Score, and zero indicates no change in the Adaptive Behavior Composite Score.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: score on a scale
	2.34 (5.93)	2.09 (6.05)

11. Secondary Outcome

Title	Change in Pervasive Developmental Disorder Behavior Inventory (PDD-BI) Repetitive, Ritualistic and Pragmatic Problems T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Repetitive, Ritualistic and Pragmatic Problems T-Score (mean=50, standard deviation=10) measures a broad range of behavioral problems associated with autism. The score ranges from 26-100 in patients aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-5.50 (10.38)	-5.18 (8.47)

12. Secondary Outcome

Title	Change in PDD-BI Approach/Withdrawal Problems T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Approach/Withdrawal Problems T-Score (mean=50, standard deviation=10) measures a broad range of behavioral problems associated with autism. The score ranges from 27-100 in patients aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-5.42 (10.60)	-4.86 (8.09)

13. Secondary Outcome

Title	Change in PDD-BI Sensory/Perceptual Approach Behaviors T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Sensory/Perceptual Approach Behaviors T-score (mean=50, standard deviation=10) includes behaviors that are largely non-communicative and involve approach toward asocial stimuli. The score ranges from 31 to 86 in patients aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-4.13 (6.80)	-2.75 (6.66)

14. Secondary Outcome

Title	Change in PDD-BI Ritualisms/Resistance to Change T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Ritualisms/Resistance to Change T-Score (mean=50, standard deviation=10) describes behaviors that communicate the child's desires to carry out rituals or to communicate dissatisfaction with a change in the environment or routine. The score ranges from 34 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-5.66 (7.62)	-5.00 (8.61)

15. Secondary Outcome

Title	Change in PDD-BI Social Pragmatic Problems T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Social Pragmatic Problems T-Score (mean=50, standard deviation=10) measures the difficulties children with autism have in either reacting to the approaches of others, understanding social conventions, or initiating social interactions with others. The score ranges from 29 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-3.66 (11.36)	-3.33 (8.78)

16. Secondary Outcome

Title	Change in PDD-BI Semantic/Pragmatic Problems T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Semantic/Pragmatic Problems T-Score (mean=50, standard deviation=10) assesses the difficulties children with autism have in using spoken language to indicate comprehension, communicate meaning, respond to the interests of others, and sustain a conversation. The score ranges from 34 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-3.82 (7.51)	-3.68 (7.90)

17. Secondary Outcome

Title	Change in PDD-BI Arousal Regulation Problems T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Arousal Regulation Problems T-Score (mean=50, standard deviation=10) measures behaviors that are largely non-communicative or unresponsive and reflect emotional constriction, the apparent seeking of kinesthetic sensation, and, in the parent version, difficulty with sleep regulation. The score ranges from 26 to 77 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-4.34 (7.49)	-5.02 (7.28)

18. Secondary Outcome

Title	Change in PDD-BI Specific Fears T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Specific Fears T-Score (mean=50, standard deviation=10) measures behaviors that communicate the fears and anxieties associated with withdrawal from social or asocial stimuli. The score ranges from 36 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-4.24 (8.81)	-3.00 (8.82)

19. Secondary Outcome

Title	Change in PDD-BI Aggressiveness T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Aggressiveness T-Score (mean=50, standard deviation=10) assesses the aggressive approach toward self or others, as well as the negative mood changes that are often associated with such behaviors. The score ranges from 36 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	-4.31 (11.41)	-1.79 (9.07)

20. Secondary Outcome

Title	Change in PDD-BI Expressive Social Communication Abilities T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Expressive Social Communication Abilities T-Score (mean=50, standard deviation=10) measures a broad range of social communication skills affected by autism. The score ranges from 20 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	3.20 (5.34)	2.74 (5.55)

21. Secondary Outcome

Title	Change in PDD-BI Receptive/Expressive Social Communication Ability T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Receptive/Expressive Social Communication Ability T-Score (mean=50, standard deviation=10) measures a broad range of social communication skills affected by autism. The score ranges from 20 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	2.99 (5.09)	2.28 (5.16)

22. Secondary Outcome

Title	Change in PDD-BI Social Approach Behaviors T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Social Approach Behaviors T-Score (mean=50, standard deviation=10) assesses those social communication skills that are notoriously difficult for children with autism (e.g., eye contact, joint attention, effective use of gesture, imaginative skills). The score ranges from 14 to 93 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	3.92 (6.46)	3.23 (5.99)

23. Secondary Outcome

Title	Change in PDD-BI Expressive Language T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Expressive Language T-Score (mean=50, standard deviation=10) assesses the ability of the child to speak the sounds associated with the English language and to use words and sentences that indicate his or her competence with grammar, tone of voice, and the pragmatic aspects of communicating with others. The score ranges from 28 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	2.03 (4.92)	1.86 (5.07)

24. Secondary Outcome

Title	Change in PDD-BI Learning, Memory, and Receptive Language T-Score
Description	The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Learning, Memory, and Receptive Language T-Score (mean=50, standard deviation=10) assesses two areas of variable competence in children with autism: (a) memory and (b) receptive language. The score ranges from 22 to 88 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	57
Mean (Standard Deviation); Unit of Measure: T score
	2.02 (5.45)	1.05 (5.37)

25. Secondary Outcome

Title	Number of Participants With Infusion Reactions
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
	2 3.3%	1 0.8%

26. Secondary Outcome

Title	Severity of Infusion Reactions
Description	Grade/severity will be assessed according to CTCAE v4.0 guidelines
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
Mild	2 3.3%	0 0.0%
Moderate	0 0.0%	1 0.8%
Severe	0 0.0%	0 0.0%

27. Secondary Outcome

Title	Number of Participants With Product-related Infections
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

28. Secondary Outcome

Title	Severity of Product-related Infections
Description	Grade/severity will be assessed according to CTCAE v4.0 guidelines
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

There were no product-related infections in the study.

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

29. Secondary Outcome

Title	Evidence of Alloimmunization Via Anti-HLA (Human Leukocyte Antigen) and Anti-RBC (Red Blood Cell) Antibodies and Nonspecific Markers of Systemic Inflammation (ESR, CRP)
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

30. Secondary Outcome

Title	Incidence of Graft vs. Host Disease
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

31. Secondary Outcome

Title	Severity of Graft vs. Host Disease
Description	Grade/severity will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 guidelines.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

There were no cases of graft vs. host disease in the study.

Arm/Group Title	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

32. Secondary Outcome

Title	Incidence of Unexpected Adverse Events, by Relation to Study Product
Description	[Not Specified]
Time Frame	6 months,12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	61	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
Related	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Unrelated	5 4.2%	1 1.6%	0 0.0%	2 1.7%

33. Secondary Outcome

Title	Severity of Unexpected Adverse Events, by Relation to Study Product
Description	Grade/severity will be assessed according to CTCAE v4.0 guidelines
Time Frame	6 months, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description:	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
Overall Number of Participants Analyzed	119	61	61	119
Measure Type: Count of Participants; Unit of Measure: Participants
Mild : Related	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Mild : Unrelated	2 1.7%	0 0.0%	0 0.0%	2 1.7%
Moderate : Related	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Moderate : Unrelated	3 2.5%	1 1.6%	0 0.0%	0 0.0%
Severe : Related	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Severe : Unrelated	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	6 months and 12 months
Adverse Event Reporting Description	Adverse events collected on Safety Population (all 180 participants). Participants were randomized to receive a single infusion of umbilical cord blood or placebo and evaluated at six months. Participants then received a second infusion in a blinded fashion (placebo for participants initially randomized to cord blood, and cord blood for participants initially randomized to placebo). Participants were then followed for an additional 6 months for safety data collection.
Arm/Group Title	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
Arm/Group Description	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo	Subjects will be randomized to receive a cord blood infusion at the baseline visit. The cord blood will be autologous (if available) or unrelated cord blood. Cord Blood Infusion	Subjects will be randomized to receive a placebo infusion at the baseline visit. The placebo is an acellular media product similar in both appearance and odor. Placebo
All-Cause Mortality
	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Serious Adverse Events
	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/119 (2.52%)	3/61 (4.92%)	3/61 (4.92%)	2/119 (1.68%)
Infections and infestations
Gastroenteritis * 1	0/119 (0.00%)	1/61 (1.64%)	1/61 (1.64%)	0/119 (0.00%)
Injury, poisoning and procedural complications
Concussion * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Metabolism and nutrition disorders
Dehydration * 1	1/119 (0.84%)	1/61 (1.64%)	1/61 (1.64%)	1/119 (0.84%)
Psychiatric disorders
Aggression * 1	0/119 (0.00%)	1/61 (1.64%)	1/61 (1.64%)	0/119 (0.00%)
Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Cord Blood Infusion - 6 Months	Placebo Infusion - 6 Months	Cord Blood Infusion - 12 Months	Placebo Infusion - 12 Months
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	97/119 (81.51%)	51/61 (83.61%)	41/61 (67.21%)	83/119 (69.75%)
Ear and labyrinth disorders
Ear pain * 1	1/119 (0.84%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Ear discomfort * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Hypoacusis * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Eye disorders
Excessive eye blinking * 1	1/119 (0.84%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Eye pain * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Photophobia * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Strabismus * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Eye inflammation * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Visual impairment * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Gastrointestinal disorders
Abdominal pain upper * 1	1/119 (0.84%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Anal incontinence * 1	2/119 (1.68%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Constipation * 1	2/119 (1.68%)	1/61 (1.64%)	1/61 (1.64%)	3/119 (2.52%)
Dental caries * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	2/119 (1.68%)
Diarrhea * 1	5/119 (4.20%)	3/61 (4.92%)	3/61 (4.92%)	2/119 (1.68%)
Dyspepsia * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Flatulence * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Food poisoning * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Frequent bowel movements * 1	1/119 (0.84%)	0/61 (0.00%)	2/61 (3.28%)	0/119 (0.00%)
Gastroesophageal reflux disease * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	2/119 (1.68%)
Nausea * 1	1/119 (0.84%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Toothache * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Vomiting * 1	5/119 (4.20%)	2/61 (3.28%)	2/61 (3.28%)	2/119 (1.68%)
Gastrointestinal dyskinetic disorders * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
General disorders
Gait disturbance * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Fatigue * 1	3/119 (2.52%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Influenza like illness * 1	1/119 (0.84%)	2/61 (3.28%)	0/61 (0.00%)	1/119 (0.84%)
Pyrexia * 1	11/119 (9.24%)	8/61 (13.11%)	8/61 (13.11%)	5/119 (4.20%)
Thirst * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Immune system disorders
Food allergy * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Hypersensitivity * 1	4/119 (3.36%)	3/61 (4.92%)	1/61 (1.64%)	9/119 (7.56%)
Drug hypersensitivity * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Infections and infestations
Candida infection * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Infection * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Infectious mononucleosis * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Lung infection * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Molluscum contagiosum * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Otitis externa * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Tooth abscess * 1	0/119 (0.00%)	1/61 (1.64%)	1/61 (1.64%)	0/119 (0.00%)
Body tinea * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Conjunctivitis * 1	5/119 (4.20%)	1/61 (1.64%)	0/61 (0.00%)	2/119 (1.68%)
Croup infectious * 1	1/119 (0.84%)	1/61 (1.64%)	0/61 (0.00%)	2/119 (1.68%)
Ear infection * 1	10/119 (8.40%)	4/61 (6.56%)	2/61 (3.28%)	7/119 (5.88%)
Erythema infection * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Fungal infection * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Gastroenteritis viral * 1	6/119 (5.04%)	3/61 (4.92%)	2/61 (3.28%)	6/119 (5.04%)
Gastrointestinal infection * 1	1/119 (0.84%)	1/61 (1.64%)	1/61 (1.64%)	1/119 (0.84%)
Hand-foot-and-mouth disease * 1	2/119 (1.68%)	0/61 (0.00%)	2/61 (3.28%)	1/119 (0.84%)
Influenza * 1	8/119 (6.72%)	2/61 (3.28%)	2/61 (3.28%)	3/119 (2.52%)
Nasopharyngitis * 1	2/119 (1.68%)	4/61 (6.56%)	0/61 (0.00%)	4/119 (3.36%)
Otitis media * 1	6/119 (5.04%)	3/61 (4.92%)	0/61 (0.00%)	2/119 (1.68%)
Overgrowth fungal * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Pharyngitis Streptococcal * 1	10/119 (8.40%)	1/61 (1.64%)	2/61 (3.28%)	6/119 (5.04%)
Pneumonia * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Scarlet fever * 1	1/119 (0.84%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Sinusitis * 1	1/119 (0.84%)	0/61 (0.00%)	1/61 (1.64%)	3/119 (2.52%)
Streptococcal infection * 1	2/119 (1.68%)	5/61 (8.20%)	1/61 (1.64%)	2/119 (1.68%)
Upper respiratory tract infection * 1	21/119 (17.65%)	10/61 (16.39%)	2/61 (3.28%)	11/119 (9.24%)
Urinary tract infection * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Viral infection * 1	2/119 (1.68%)	1/61 (1.64%)	0/61 (0.00%)	1/119 (0.84%)
Oral herpes * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Bronchitis * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Injury, poisoning and procedural complications
Clavicle fracture * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Epiphyseal fracture * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Allergic transfusion reaction * 1	7/119 (5.88%)	1/61 (1.64%)	2/61 (3.28%)	1/119 (0.84%)
Fall * 1	1/119 (0.84%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Infusion related reaction * 1	3/119 (2.52%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Facial bones fracture * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Wrist fracture * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	1/119 (0.84%)
Investigations
Blood urine present * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Laboratory test abnormal * 1	4/119 (3.36%)	0/61 (0.00%)	2/61 (3.28%)	14/119 (11.76%)
Vitamin D decreased * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Streptococcus test positive * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Cardiac murmur * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Weight increased * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	2/119 (1.68%)
Metabolism and nutrition disorders
Appetite disorder * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Decreased appetite * 1	2/119 (1.68%)	0/61 (0.00%)	1/61 (1.64%)	1/119 (0.84%)
Cow's milk intolerance * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Food refusal * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Gluten sensitivity * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Increased appetite * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	3/119 (2.52%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Joint laxity * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Muscle rigidity * 1	6/119 (5.04%)	4/61 (6.56%)	1/61 (1.64%)	2/119 (1.68%)
Toe walking * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	2/119 (1.68%)
Nervous system disorders
Restless legs syndrome * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Disturbance in attention * 1	4/119 (3.36%)	2/61 (3.28%)	1/61 (1.64%)	1/119 (0.84%)
Headache * 1	3/119 (2.52%)	2/61 (3.28%)	0/61 (0.00%)	1/119 (0.84%)
Lethargy * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Poor quality sleep * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Psychomotor hyperactivity * 1	5/119 (4.20%)	5/61 (8.20%)	2/61 (3.28%)	6/119 (5.04%)
Repetitive speech * 1	1/119 (0.84%)	1/61 (1.64%)	0/61 (0.00%)	1/119 (0.84%)
Seizure * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Sensory processing disorder * 1	10/119 (8.40%)	5/61 (8.20%)	2/61 (3.28%)	2/119 (1.68%)
Somnolence * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Syncope * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Sensory disturbance * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Speech disorder * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Psychiatric disorders
Bipolar disorder * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Distractibility * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Dysphemia * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Affect lability * 1	9/119 (7.56%)	7/61 (11.48%)	0/61 (0.00%)	9/119 (7.56%)
Aggression * 1	22/119 (18.49%)	12/61 (19.67%)	6/61 (9.84%)	14/119 (11.76%)
Agitation * 1	13/119 (10.92%)	7/61 (11.48%)	6/61 (9.84%)	7/119 (5.88%)
Anxiety * 1	1/119 (0.84%)	2/61 (3.28%)	1/61 (1.64%)	2/119 (1.68%)
Apathy * 1	4/119 (3.36%)	1/61 (1.64%)	0/61 (0.00%)	1/119 (0.84%)
Attention deficit/hyperactivity disorder * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Confusional state * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Defiant behavior * 1	10/119 (8.40%)	4/61 (6.56%)	4/61 (6.56%)	7/119 (5.88%)
Depressed mood * 1	3/119 (2.52%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Echolalia * 1	3/119 (2.52%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Encopresis * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Enuresis * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Food aversion * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Frustration tolerance decreased * 1	4/119 (3.36%)	2/61 (3.28%)	2/61 (3.28%)	4/119 (3.36%)
Impulsive behavior * 1	3/119 (2.52%)	3/61 (4.92%)	1/61 (1.64%)	1/119 (0.84%)
Insomnia * 1	11/119 (9.24%)	2/61 (3.28%)	5/61 (8.20%)	6/119 (5.04%)
Intentional self-injury * 1	4/119 (3.36%)	3/61 (4.92%)	2/61 (3.28%)	1/119 (0.84%)
Irritability * 1	6/119 (5.04%)	3/61 (4.92%)	0/61 (0.00%)	3/119 (2.52%)
Negativism * 1	3/119 (2.52%)	2/61 (3.28%)	1/61 (1.64%)	0/119 (0.00%)
Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Separation anxiety disorder * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Sleep disorder * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Social avoidant behavior * 1	1/119 (0.84%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Stereotypy * 1	16/119 (13.45%)	6/61 (9.84%)	1/61 (1.64%)	6/119 (5.04%)
Tic * 1	2/119 (1.68%)	1/61 (1.64%)	1/61 (1.64%)	2/119 (1.68%)
Aversion * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Restlessness * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Reproductive system and breast disorders
Nipple swelling * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhea * 1	0/119 (0.00%)	2/61 (3.28%)	1/61 (1.64%)	0/119 (0.00%)
Asthma * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Epistaxis * 1	5/119 (4.20%)	1/61 (1.64%)	1/61 (1.64%)	3/119 (2.52%)
Hypoxia * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Cough * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	4/119 (3.36%)
Oropharyngeal pain * 1	0/119 (0.00%)	0/61 (0.00%)	1/61 (1.64%)	0/119 (0.00%)
Nasal congestion * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Sinus congestion * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Skin and subcutaneous tissue disorders
Dermatitis diaper * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Eczema * 1	2/119 (1.68%)	3/61 (4.92%)	0/61 (0.00%)	3/119 (2.52%)
Pruritus * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Rash * 1	4/119 (3.36%)	2/61 (3.28%)	3/61 (4.92%)	4/119 (3.36%)
Rash papular * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Urticaria * 1	2/119 (1.68%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Alopecia * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Dermatitis contact * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Surgical and medical procedures
Adenoidectomy * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	1/119 (0.84%)
Ear tube removal * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Tonsillectomy * 1	0/119 (0.00%)	1/61 (1.64%)	0/61 (0.00%)	0/119 (0.00%)
Myringotomy * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Tooth repair * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Tooth extraction * 1	0/119 (0.00%)	0/61 (0.00%)	0/61 (0.00%)	1/119 (0.84%)
Vascular disorders
Hypotension * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
Pallor * 1	1/119 (0.84%)	0/61 (0.00%)	0/61 (0.00%)	0/119 (0.00%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Jesse D. Troy, PhD, MPH
• Organization: Duke University
• Phone: 919-668-1102
• EMail: cordbloodtherapyinfo@dm.duke.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Simhal AK, Carpenter KLH, Kurtzberg J, Song A, Tannenbaum A, Zhang L, Sapiro G, Dawson G. Changes in the geometry and robustness of diffusion tensor imaging networks: Secondary analysis from a randomized controlled trial of young autistic children receiving an umbilical cord blood infusion. Front Psychiatry. 2022 Oct 20;13:1026279. doi: 10.3389/fpsyt.2022.1026279. eCollection 2022.

• Responsible Party: Joanne Kurtzberg, MD, Duke University
• ClinicalTrials.gov Identifier: NCT02847182
• Other Study ID Numbers: Pro00070514
• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Results First Submitted: August 20, 2019
• Results First Posted: December 26, 2019
• Last Update Posted: June 9, 2020