FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
NCT ID: NCT01486732
Last Updated: 2013-11-19
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Umbilical Cord Blood & 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 continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
Placebo Umbilical Cord Blood & Rehabilitation
Placebo Umbilical Cord Blood infusion and active rehabilitation
Active Rehabilitation
All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
Placebo Umbilical Cord Blood
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin
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.
Active Rehabilitation
All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
Placebo Umbilical Cord Blood
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Abnormal muscle tone
* 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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Bundang CHA Hospital
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
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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CP FLT-PET
Identifier Type: -
Identifier Source: org_study_id