A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis (FREEDOM-3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Talaris Therapeutics Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new cell therapy called FCR001 for adults with severe skin disease that can cause organ failure. The treatment involves giving special donor cells through an IV drip to help the body accept these new cells without attacking them. FCR001 is a mobilized blood product enriched in stem cells and facilitating cells, which has been used before in patients with kidney transplants.
Eligibility Criteria
Participant Groups
1Treatment groups
Experimental Treatment
Group I: FCR001Experimental Treatment1 Intervention
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood cells and delivered as a single infusion with a nonmyeloablative conditioning regimen.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who is running the clinical trial?
Talaris Therapeutics Inc.Lead Sponsor