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Cell Therapy
FCR001 for Systemic Sclerosis (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
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
- Systemic Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: FCR001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Systemic Sclerosis Patient Testimony for trial: Trial Name: NCT05098145 — Phase 1 & 2
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