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NCT07086521 · ClinicalTrials.gov registry record · Phase 1
Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
A Phase 1 study of FSHD - Facioscapulohumeral Muscular Dystrophy, sponsored by Restem.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT07086521 is a Phase 1 study of FSHD - Facioscapulohumeral Muscular Dystrophy that is actively recruiting participants, run by Restem. The registered enrollment target is 16 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07086521, a Phase 1 study of FSHD - Facioscapulohumeral Muscular Dystrophy, is actively recruiting participants, sponsored by Restem.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell product (ULSC) performs when treating Facioscapulohumeral Muscular Dystrophy (FSHD) 1 or 2. It will assess safety and preliminary efficacy in relieving symptoms of FSHD with ULSC administered in two intravenous (IV) doses of 100 million cells per dose. The main questions that this study plans to answer are: * Is ULSC as safe as placebo (a look-alike saline without cells) in repeated IV infusion? * Does ULSC improve symptoms of FSHD after each dose? Researchers will compare ULSC to placebo. Participants will: * Have been diagnosed with FSHD of a Ricci clinical severity score 3 or more. * Participate in this study for total duration of 21 months with 11 in-person visits and 5 virtual visits. * Visit the clinic for a total of 4 IV infusions (250 mL) 3 months apart. * Receive 2 doses of ULSC and 2 doses placebo in either of two sequences, as assigned: ULSC first (Day 0 and Month 3) and placebo second (Month 6 and Month 9), or placebo first (Day 0 and Month 3) and ULSC second (Month 6 and Month 9). * Return for follow-up visits after each dose and up to 12 months after final dose.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ULSC
Study Locations (1)
California
- Stanford Neuroscience Health Center - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07086521
The ClinicalTrials.gov registry entry for NCT07086521 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Restem, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with FSHD - Facioscapulohumeral Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07086521 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT07086521 about?
NCT07086521 is a clinical study titled "Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)". The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell product (ULSC) performs when treating Facioscapulohumeral Muscular Dystrophy (FSHD) 1 or 2. It will assess safety and preliminary efficacy in relieving symptoms of FSHD with ULSC administered in two intr...
What is the current status of trial NCT07086521?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-12-01. Estimated completion is 2029-03.
What conditions does trial NCT07086521 study?
This clinical trial studies the following conditions: FSHD - Facioscapulohumeral Muscular Dystrophy.
What interventions are being tested in trial NCT07086521?
The interventions under investigation include: Placebo (BIOLOGICAL), ULSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT07086521?
This trial is sponsored by Restem, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07086521 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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