Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Umbilical Cord Blood, FLT-PET
Brief summary
This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.
Detailed description
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.
Interventions
BIOLOGICALUmbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
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 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
Sponsors
Bundang CHA Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of FLT-PET Activity Change | Baseline - 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Neurodevelopmental Outcome | Baseline - 2 weeks - 3 months | Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor and Mental Scales (Higher score means better motor and mental function). |
| Changes in Standardized Gross Motor Function | Baseline - 2 weeks - 3 months | 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). |
| Changes in Quality of Movement | Baseline - 2 weeks - 3 months | 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. |
Countries
South Korea
Outcome results
None listed