Your session is about to expire
← Back to Search
Cell Therapy
A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-transplant
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