Actively Recruiting
Study of Intravenous Infusion of Cultured Adult Umbilical Cord Stem Cells for Treating Cerebral Palsy to Assess Safety and Effectiveness
Led by The Foundation for Orthopaedics and Regenerative Medicine · Updated on 2025-04-08
15
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells in treating Cerebral Palsy. The study is patient-funded and focuses on monitoring both safety and efficacy outcomes over a long period. Participants will receive a single intravenous infusion of 100 million umbilical cord derived mesenchymal stem cells. This is a Phase 1 interventional trial where the treatment group receives this experimental biological therapy. There are no placebo or comparator groups mentioned. Participants will be assessed before treatment and then at 1, 6, 12, 24, 36, and 48 months after infusion to monitor safety through adverse event tracking and efficacy through the Gross Motor Function Measure GMFM. The study includes a four-year follow-up period to evaluate long-term outcomes and safety. Total involvement spans multiple years with regular evaluations.
CONDITIONS
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CP
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