FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy

Study Overview
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Brief Summary
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This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.

Detailed Description
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FLT(3'-Deoxy-3'-[F-18]Fluorothymidine) has been developed as a cell-proliferation tracer. In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively. This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.

Official Title
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FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Biological: Umbilical Cord Blood Infusion
* Other: Active Rehabilitation
* Other: Placebo Umbilical Cord Blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cerebral Palsy Abnormal muscle tone Gross Motor Function Classification System (GMFCS): I, II, III, IV, V Willing to comply with all study procedure Exclusion Criteria: Medical instability including pneumonia or renal function at enrollment 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical Cord Blood & Rehabilitation<br>Allogeneic umbilical cord blood infusion and active rehabilitation | Biological: Umbilical Cord Blood Infusion<br>* The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.<br>* Other names: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank;Other: Active Rehabilitation<br>* 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.<br>|
| Active Comparator: Placebo Umbilical Cord Blood & Rehabilitation<br>Placebo Umbilical Cord Blood infusion and active rehabilitation | Other: Active Rehabilitation<br>* 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.<br>Other: Placebo Umbilical Cord Blood<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of FLT-PET Activity Change | Comparison of FLT-PET Activity Change between UCB group and Placebo group during 2 weeks: To compare differences in regional brain FLT-PET activity between groups and differences between pre- and post-therapy imaging data. The baseline and post-therapy data of each group will be compared using paired t-test statistics. | Baseline - 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Neurodevelopmental Outcome | Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor and Mental Scales (Higher score means better motor and mental function). | Baseline - 2 weeks - 3 months | 
| Changes in Standardized Gross Motor Function | GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0 100 %, Higher score means better motor function). | Baseline - 2 weeks - 3 months | 
| Changes in Quality of Movement | GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift. | Baseline - 2 weeks - 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Umbilical Cord Blood, FLT-PET