Safety and Effectiveness of Banked Cord Blood or Bone Marrow Stem Cells in Children With Cerebral Palsy (CP). (ACT for CP)
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ClinicalTrials.gov Identifier: NCT01988584 |
Recruitment Status :
Completed
First Posted : November 20, 2013
Results First Posted : November 21, 2022
Last Update Posted : November 21, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Cerebral Palsy |
Interventions |
Biological: umbilical cord blood (hUCB) cells Drug: Saline Infusion (Placebo) Biological: bone marrow derived mononuclear cells (BMMNCs) |
Enrollment | 20 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Umbilical Cord Blood (UCB) Cells | Bone Marrow-derived Mononuclear Cells (BMMNCs) | Saline Infusion (Placebo), Then Umbilical Cord Blood (UCB) Cells | Saline Infusion (Placebo), Then Bone Marrow-derived Mononuclear Cells (BMMNCs) |
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Children who have banked UCB with CBR will receive an umbilical cord blood stem cell infusion at the baseline/treatment visit. umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. |
Children in the BMMNC group will undergo bone marrow harvest and stem cell infusion at the baseline/treatment visit. bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. |
Five children in each group will be randomly assigned to receive an inactive substance (placebo) at the baseline/treatment visit. Parents will be given the opportunity to cross-over to either the umbilical cord blood or bone marrow harvest group at the one year visit. umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. Saline Infusion (Placebo): A total of 10 children (5 from each cohort) will be randomized to a placebo infusion at the baseline visit and then have the opportunity to cross-over to stem cell treatment at the 1yr. visit. |
Saline Infusion (Placebo): A total of 10 children (5 from each cohort) will be randomized to a placebo infusion at the baseline visit and then have the opportunity to cross-over to stem cell treatment at the 1yr. visit. bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. |
Period Title: Blinded Phase | ||||
Started | 3 | 10 | 2 | 5 |
12 Month Follow-up | 3 | 9 | 2 | 5 |
Completed | 3 | 9 | 2 | 4 [1] |
Not Completed | 0 | 1 | 0 | 1 |
[1]
One BMMNC Subject Lost To Follow-up After 1yr. Cross-Over Visit
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Period Title: Unblinded Phase - Placebo Arm Crossover | ||||
Started [1] | 0 | 0 | 2 | 5 |
Completed [2] | 0 | 0 | 2 | 4 |
Not Completed | 0 | 0 | 0 | 1 |
[1]
Placebo arms cross over to stem cell intervention 12 months after start of study.
[2]
Crossover arms complete follow-up 12 months after start of stem cell intervention (which is 24 months after start of study).
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Arm/Group Title | Umbilical Cord Blood (UCB) Cells | Bone Marrow-derived Mononuclear Cells (BMMNCs) | Total | |
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Children who have banked UCB with CBR will receive an umbilical cord blood stem cell infusion at the baseline/treatment visit. umbilical cord blood (hUCB) cells: Autologous umbilical cord blood banked with the Cord Blood Registry. |
Children in the BMMNC group will undergo bone marrow harvest and stem cell infusion at the baseline/treatment visit. bone marrow derived mononuclear cells (BMMNCs): Autologous stem cells from bone marrow harvest. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 5 | 15 | 20 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 5 participants | 15 participants | 20 participants | |
<=18 years |
5 100.0%
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15 100.0%
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20 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 5 participants | 15 participants | 20 participants | |
4 (2.12) | 6.13 (2.92) | 5.6 (2.85) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 5 participants | 15 participants | 20 participants | |
Female |
2 40.0%
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6 40.0%
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8 40.0%
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Male |
3 60.0%
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9 60.0%
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12 60.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 5 participants | 15 participants | 20 participants | |
Hispanic or Latino |
1 20.0%
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0 0.0%
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1 5.0%
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Not Hispanic or Latino |
4 80.0%
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15 100.0%
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19 95.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 5 participants | 15 participants | 20 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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2 13.3%
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2 10.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
|
0 0.0%
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White |
4 80.0%
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13 86.7%
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17 85.0%
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More than one race |
1 20.0%
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0 0.0%
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1 5.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 5 participants | 15 participants | 20 participants |
United States |
5 100.0%
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13 86.7%
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18 90.0%
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United Kingdom |
0 0.0%
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1 6.7%
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1 5.0%
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Italy |
0 0.0%
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1 6.7%
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1 5.0%
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Name/Title: | Charles S. Cox, MD, Professor |
Organization: | The University of Texas Health Science Center at Houston |
Phone: | 713-500-7300 |
EMail: | charles.s.cox@uth.tmc.edu |
Responsible Party: | Charles Cox, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT01988584 |
Other Study ID Numbers: |
HSC-MS-12-0876 |
First Submitted: | November 4, 2013 |
First Posted: | November 20, 2013 |
Results First Submitted: | October 29, 2020 |
Results First Posted: | November 21, 2022 |
Last Update Posted: | November 21, 2022 |