NCT07160205View on ClinicalTrials.gov

Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

May 31, 2029

Conditions
Idiopathic Inflammatory Myositis (IIM)DERMATOMYOSITIS OR POLYMYOSITIS
Interventions
BIOLOGICAL

ULSC (1.5 x 10^8 cells/dose)

Allogeneic umbilical-cord lining stem cells (ULSC) are cryopreserved and supplied in vials to be thawed and prepared for infusion at point of use. Each dose of 1.5 x 10\^8 ULSC will be added into 250 sterile saline IV bag for infusion (total volume of 260 mL volume).

BIOLOGICAL

Placebo (no cells)

The Placebo will be 250 ml sterile saline with vehicle (total volume of 260 mL) IV bag for infusion.

Trial Locations (1)

32608

Malcom Randall North Florida/South Georgia VA Medical Center, Gainesville

All Listed Sponsors
lead

Restem, LLC.

INDUSTRY

NCT07160205 - Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM) | Biotech Hunter | Biotech Hunter