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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
Screening 3 weeks
Treatment Varies
Follow Up from infusion to 60 months
Awards & highlights


This trial will test a new cell therapy for people with a rapidly progressive form of scleroderma that is at risk for organ failure.

Eligible Conditions
  • Systemic Sclerosis


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from infusion to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from infusion to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of recipient adverse events (AEs)
Incidence of recipient serious adverse events (SAEs)
Occurrence of Graft versus Host Disease (GvHD)
+2 more
Secondary outcome measures
Incidence of donor AEs
Incidence of donor SAEs
Percent donor whole blood chimerism
+1 more

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
Systemic Sclerosis Research Study Groups: FCR001
Systemic Sclerosis 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
Systemic Sclerosis Patient Testimony for trial: Trial Name: NCT05098145 — Phase 1 & 2
~0 spots leftby Nov 2026