Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2012-02-29
2012-07-31
Brief Summary
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Detailed Description
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Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.
On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation
Umbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Active Rehabilitation
All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Placebo Umbilical Cord Blood and Rehabilitation
Placebo Umbilical Cord Blood infusion and Active Rehabilitation
Placebo Umbilical Cord Blood
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.
Active Rehabilitation
All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Interventions
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Umbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Placebo Umbilical Cord Blood
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.
Active Rehabilitation
All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure
Exclusion Criteria
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome
6 Months
20 Years
ALL
No
Sponsors
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MinYoung Kim, M.D.
OTHER
Responsible Party
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MinYoung Kim, M.D.
Associate Professor
Principal Investigators
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Minyoung Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CHA University
Locations
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CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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CPUCBRCT
Identifier Type: -
Identifier Source: org_study_id
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