Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sung Kwang Medical Foundation

ClinicalTrials.gov Identifier:

NCT01193660

First received: August 29, 2010

Last updated: March 1, 2012

Last verified: March 2012

History of Changes

Results First Received: October 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Cerebral Palsy
Interventions:	Biological: Umbilical Cord Blood Infusion Drug: Erythropoietin Injection Other: Active Rehabilitation Other: Placebo Umbilical Cord Blood Other: Placebo Erythropoietin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment Period: May 31, 2010 through April 9, 2011 All participants were recruited at CHA Bundang Medical Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We tried to recruit 106 subjects. Finally 105 patients were enrolled at the beginning of the overall study and none of the participants were washed out before assignment to groups.

Reporting Groups

	Description
Umbilical Cord Blood & Erythropoietin & Rehabilitation	Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
Erythropoietin & Rehabilitation	Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
Only Rehabilitation	Active rehabilitation

Participant Flow: Overall Study

	Umbilical Cord Blood & Erythropoietin & Rehabilitation	Erythropoietin & Rehabilitation	Only Rehabilitation
STARTED	35	36	34
COMPLETED	31	33	32
NOT COMPLETED	4	3	2
Withdrawal by Subject	2	3	1
Death	1	0	0
Physician Decision	1	0	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Umbilical Cord Blood & Erythropoietin & Rehabilitation	Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
Erythropoietin & Rehabilitation	Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
Only Rehabilitation	Active rehabilitation
Total	Total of all reporting groups

Baseline Measures

	Umbilical Cord Blood & Erythropoietin & Rehabilitation	Erythropoietin & Rehabilitation	Only Rehabilitation	Total
Number of Participants [units: participants]	35	36	34	105
Age [units: participants]
<=18 years	35	36	34	105
Between 18 and 65 years	0	0	0	0
>=65 years	0	0	0	0
Age [units: months] Mean ± Standard Deviation	45.71 ± 18.91	50.05 ± 24.45	46.0 ± 19.58	47.30 ± 21.07
Gender [units: participants]
Female	13	11	9	33
Male	22	25	25	72
Region of Enrollment [units: participants]
Korea, Republic of	35	36	34	105

Outcome Measures

Show All Outcome Measures

1. Primary:

Changes in Motor Performance [ Time Frame: Baseline -1 month - 3 months - 6 months ]

Show Outcome Measure 1

2. Primary:

Changes in Standardized Gross Motor Function [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

Show Outcome Measure 2

3. Secondary:

Changes in Cognitive Neurodevelopmental Outcome [ Time Frame: Baseline -1 month - 3 months - 6 months ]

Show Outcome Measure 3

4. Secondary:

Changes in Motor Neurodevelopmental Outcome [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

Show Outcome Measure 4

5. Secondary:

Changes in Brain MRI [ Time Frame: Baseline - 6 months ]

Show Outcome Measure 5

6. Secondary:

Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism [ Time Frame: Baseline - 2 weeks ]

Show Outcome Measure 6

7. Secondary:

Changes in Functional Performance in Daily Activities [ Time Frame: Baseline -1 month - 3 months - 6 months ]

Show Outcome Measure 7

8. Secondary:

Changes in Functional Independence in Daily Activities [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

Show Outcome Measure 8

9. Secondary:

Changes in Muscle Strength [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

Show Outcome Measure 9

10. Secondary:

Changes in Hand Function [ Time Frame: Baseline - 1 month - 3 months - 6 months ]

Show Outcome Measure 10

11. Secondary:

Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant [ Time Frame: 6 months ]

Show Outcome Measure 11

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	Baseline - 1 month - 3 months - 6 months
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Umbilical Cord Blood & Erythropoietin & Rehabilitation	Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
Erythropoietin & Rehabilitation	Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
Only Rehabilitation	Active rehabilitation

Other Adverse Events

	Umbilical Cord Blood & Erythropoietin & Rehabilitation	Erythropoietin & Rehabilitation	Only Rehabilitation
Total, other (not including serious) adverse events
# participants affected / at risk	30/35	29/36	32/34
Blood and lymphatic system disorders
Anemia ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/0 (0.00%)	0/18 (0.00%)
# events	1	0	0
Ear and labyrinth disorders
Otitis media acute ^{† 1}
# participants affected / at risk	1/35 (2.86%)	1/14 (7.14%)	0/18 (0.00%)
# events	1	1	0
Eye disorders
Conjunctival irritations ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/14 (7.14%)	1/18 (5.56%)
# events	0	1	2
Gastrointestinal disorders
Constipation ^{† 1}
# participants affected / at risk	5/35 (14.29%)	4/14 (28.57%)	5/18 (27.78%)
# events	5	4	5
Dyspepsia ^{† 1}
# participants affected / at risk	5/35 (14.29%)	2/36 (5.56%)	2/18 (11.11%)
# events	5	2	2
Nausea, vomiting ^{† 1}
# participants affected / at risk	6/35 (17.14%)	5/36 (13.89%)	2/18 (11.11%)
# events	6	5	2
Diarrhea ^{† 1}
# participants affected / at risk	6/35 (17.14%)	2/36 (5.56%)	2/18 (11.11%)
# events	6	2	2
Colitis ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/14 (7.14%)	2/18 (11.11%)
# events	0	1	2
Anorexia ^{† 1}
# participants affected / at risk	5/35 (14.29%)	2/36 (5.56%)	1/18 (5.56%)
# events	5	2	1
Infections and infestations
Herpangina ^{† 1}
# participants affected / at risk	0/35 (0.00%)	2/14 (14.29%)	1/18 (5.56%)
# events	0	2	1
Fever ^{† 1}
# participants affected / at risk	12/35 (34.29%)	4/36 (11.11%)	8/18 (44.44%)
# events	12	4	8
Nervous system disorders
Seizure ^{† 1}
# participants affected / at risk	1/35 (2.86%)	3/36 (8.33%)	3/18 (16.67%)
# events	1	6	7
Febrile convulsioin ^{† 1}
# participants affected / at risk	2/35 (5.71%)	1/14 (7.14%)	0/18 (0.00%)
# events	3	1	0
Psychiatric disorders
Irritability ^{† 1}
# participants affected / at risk	4/35 (11.43%)	0/14 (0.00%)	0/18 (0.00%)
# events	4	0	0
Insomnia ^{† 1}
# participants affected / at risk	0/35 (0.00%)	1/36 (2.78%)	1/18 (5.56%)
# events	0	1	1
Respiratory, thoracic and mediastinal disorders
Bronchitis ^{† 1}
# participants affected / at risk	4/35 (11.43%)	4/14 (28.57%)	3/18 (16.67%)
# events	4	4	3
Pneumonia ^{† 1}
# participants affected / at risk	6/35 (17.14%)	0/14 (0.00%)	0/18 (0.00%)
# events	6	0	0
Upper respiratory tract infection ^{† 1}
# participants affected / at risk	18/35 (51.43%)	19/36 (52.78%)	21/34 (61.76%)
# events	20	23	24
Hypoxia ^{† 1 [3]}
# participants affected / at risk	3/35 (8.57%)	1/36 (2.78%)	1/18 (5.56%)
# events	3	1	1
Skin and subcutaneous tissue disorders
Dermatitis ^{† 1}
# participants affected / at risk	0/35 (0.00%)	2/36 (5.56%)	2/18 (11.11%)
# events	0	2	2
Urticaria ^{† 1}
# participants affected / at risk	2/35 (5.71%)	1/14 (7.14%)	4/18 (22.22%)
# events	2	1	4
Hirsuitism ^{† 1}
# participants affected / at risk	2/35 (5.71%)	0/0 (0.00%)	0/0 (0.00%)
# events	2	0	0
Alopecia ^{† 1}
# participants affected / at risk	1/35 (2.86%)	0/0 (0.00%)	0/0 (0.00%)
# events	1	0	0

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 14.1
[3]	Temporary O2 desaturation(89-91%) at the end of UCB infusion in UCB group; O2 desaturation(91%) shortly during sedation for PET in EPO group; O2 desaturation(71-95%) intermittently during 47 min maybe from postictal respiratory depression in control

More Information

Show More Information

To Top