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| Sponsor: | Minyoung Kim, M.D. |
|---|---|
| Information provided by (Responsible Party): | Minyoung Kim, M.D., Bundang CHA Hospital |
| ClinicalTrials.gov Identifier: | NCT01528436 |
Purpose
This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Palsy |
Biological: Umbilical Cord Blood Infusion Other: Placebo Umbilical Cord Blood Other: Active Rehabilitation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Umbilical Cord Blood Therapy for Cerebral Palsy: a Randomized,Double-blind, Placebo-controlled Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation
|
Biological: Umbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Name: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Other: 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.
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Active Comparator: Placebo Umbilical Cord Blood and Rehabilitation
Placebo Umbilical Cord Blood infusion and Active Rehabilitation
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Other: Placebo Umbilical Cord Blood
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.
Other: 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.
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Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.
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.
Eligibility| Ages Eligible for Study: | 6 Months to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Korea, Republic of | |
| CHA Bundang Medical Center, CHA University | |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712 | |
| Principal Investigator: | Minyoung Kim, M.D., Ph.D. | CHA Bundang Medical Center, CHA University |
More Information
| Responsible Party: | Minyoung Kim, M.D., Associate Professor, Bundang CHA Hospital |
| ClinicalTrials.gov Identifier: | NCT01528436 History of Changes |
| Other Study ID Numbers: | CPUCBRCT |
| Study First Received: | February 3, 2012 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Korea: Institutional Review Board |
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Cerebral Palsy Umbilical Cord Blood Rehabilitation |
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |