drugset / Trial / NCT04723303

Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)

NCT04723303 ↗

Phase 0 Completed 10 enrolled University of Florida Restem, LLC. · collab
NaSequentialOpen-labelTreatment

Summary

This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.

Timeline

Start
2021-10-06
Primary completion
2023-12-12
Completion
2024-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Umbilical Cord Lining Stem Cells Cell therapy 5e+07 cells Intravenous
Subject Umbilical Cord Lining Stem Cells Cell therapy 1e+08 cells Intravenous
Subject Umbilical Cord Lining Stem Cells Cell therapy 2e+08 cells Intravenous

Indications