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Difficulty in obtaining specific isotope tracer
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This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Blood & Rehabilitation | Experimental | Allogeneic umbilical cord blood infusion and active rehabilitation |
|
| Placebo Umbilical Cord Blood & Rehabilitation | Active Comparator | Placebo Umbilical Cord Blood infusion and active rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Blood Infusion | Biological | The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minyoung Kim, M.D., Ph.D. | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Active Rehabilitation | Other | 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 | Other | 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 |
|
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 |