drugset / Trial / NCT03158896

Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease

NCT03158896 ↗

Phase 1 Completed 24 enrolled University of Kansas Medical Center
NaSequentialOpen-labelTreatment

Summary

This study evaluates the safety and effectiveness of two different doses of umbilical cord derived, ex-vivo cultured and expanded Wharton's jelly mesenchymal stem cells (MSCTC-0010) in the treatment of acute Graft versus Host Disease (aGVHD). The first 5 participants enrolled in the study will receive a lower dose of MSCTC-0010. If none of the first 5 participants have treatment-related serious adverse events (TRSAEs) for 42 days, then the next 5 participants will receive a slightly higher dose of MSCTC-0010.

Timeline

Start
2018-07-09
Primary completion
2025-12-08
Completion
2025-12-08

Drugs

EvaluationDrugModalityDoseRoute
Subject MSCTC-0010 Cell therapy 2e+06 cells/kg —
Subject MSCTC-0010 Cell therapy 1e+07 cells/kg —