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Is Autologous Umbilical Cord Blood Reinfusion Beneficial in Children With Cerebral Palsy: A Randomized, Blinded, Placebo-Controlled, Crossover Study
The purpose of this study is to determine the efficacy of a single intravenous infusion of autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic cerebral palsy.
Details
| Lead sponsor | Joanne Kurtzberg, MD |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 63 |
| Start date | 2010-06 |
| Completion | 2016-03 |
Conditions
- Cerebral Palsy
- CP
- Spastic Cerebral Palsy
Interventions
- Autologous UCB Reinfusion
- Placebo
Primary outcomes
- Change in Gross Motor Function Measure 66 (GMFM-66) Score — Baseline to Year 1
Change in Gross Motor Function Measure 66 (GMFM-66) Score from Baseline to Year 1. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.
Countries
United States