NCT07086521View on ClinicalTrials.gov

Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)

PHASE1RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

January 31, 2029

Conditions
FSHD - Facioscapulohumeral Muscular Dystrophy
Interventions
BIOLOGICAL

ULSC

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 x 10\^8 ULSC will be added to into 250 sterile saline for infusion (total volume of 260 mL volume).

BIOLOGICAL

Placebo

The Placebo will be 250 ml of sterile saline for IV administration.

Trial Locations (1)

94304

RECRUITING

Stanford Neuroscience Health Center, Palo Alto

All Listed Sponsors
collaborator

Solve FSHD

UNKNOWN

lead

Restem, LLC.

INDUSTRY