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Cell Therapy

FCR001 for Scleroderma (FREEDOM-3 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Talaris Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Scleroderma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Talaris Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
102 Total Patients Enrolled
Ken Abrams, MDStudy DirectorTalaris Therapeutics
2 Previous Clinical Trials
37 Total Patients Enrolled
Joel Weinthal, MDStudy DirectorTalaris Therapeutics

Media Library

FCR001 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05098145 — Phase 1 & 2
Scleroderma Research Study Groups: FCR001
Scleroderma Clinical Trial 2023: FCR001 Highlights & Side Effects. Trial Name: NCT05098145 — Phase 1 & 2
FCR001 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098145 — Phase 1 & 2
Scleroderma Patient Testimony for trial: Trial Name: NCT05098145 — Phase 1 & 2
~0 spots leftby Nov 2026
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