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Cell Therapy

FCR001 for Transplant Rejection (FREEDOM-1 Trial)

Phase 3
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 24 months post-transplant
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new cell therapy called FCR001 for patients receiving a kidney transplant from a living donor. The therapy uses special cells to help the body accept the new kidney. The goal is to see if this method is safer and more effective than the usual medications used to prevent organ rejection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FCR001Experimental Treatment1 Intervention
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
Group II: ControlActive Control1 Intervention
Standard induction therapy followed by a maintenance regimen of tacrolimus, mycophenolate, and +/- corticosteroids after kidney transplant. Control donors are not followed beyond randomization.

Find a Location

Who is running the clinical trial?

Talaris Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
87 Total Patients Enrolled
~2 spots leftby Nov 2025
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