Actively Recruiting
Safety Evaluation of Intravenous Allogeneic Adult Umbilical Cord Mesenchymal Stem Cells for Autism Treatment
Led by The Foundation for Orthopaedics and Regenerative Medicine · Updated on 2025-04-08
15
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for treating Autism. This phase 1 trial focuses on examining whether this stem cell treatment can be safely administered and how well it works in autism patients. Participants will receive a single intravenous infusion containing 100 million mesenchymal stem cells. The study involves only one treatment group receiving this infusion. There are no placebo or control groups, and the study follows patients over an extended period to monitor long-term effects. Participants will be evaluated before treatment and then followed up at 1, 6, 12, 24, 36, and 48 months after the infusion. These evaluations will include safety monitoring for any adverse events and assessments of treatment efficacy using the Autism Treatment Evaluation Checklist ATEC. This comprehensive follow-up ensures careful tracking of both safety and potential benefits over four years.
CONDITIONS
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism
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