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Phase 1
All Genders
ID05018767

Safety Study of Intravenous Infusion of Cultured Adult Umbilical Cord Stem Cells to Treat Aging Frailty

Led by The Foundation for Orthopaedics and Regenerative Medicine · Updated on 2025-04-04

86

Participants Needed

3

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs for treating Aging Frailty. This patient-funded phase 1 trial focuses on patients diagnosed with Frailty, aiming to assess how well this stem cell treatment works and its safety profile. Participants will receive a single intravenous infusion of 100 million UC-MSC cells. The treatment involves just one dose administered intravenously, with no placebo or comparison group mentioned. The study includes follow-up visits at 1, 6, 12, 24, 36, and 48 months after treatment to monitor patient outcomes. During the study, participants will be evaluated before treatment and at multiple time points afterward to check for safety and treatment effects. Researchers will watch for any adverse events over a four-year period. Assessments include clinical evaluations and laboratory tests to track safety and efficacy. Participants can expect regular monitoring visits as part of this long-term study.

CONDITIONS

Brief Title

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty

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