A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation (FREEDOM-1)

A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation (FREEDOM-1)

Brief Summary:
A randomized controlled study to assess the safety and efficacy and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

Detailed Description:
The purpose of this randomized (2:1) controlled study is to assess the safety, efficacy and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation relative to a standard-of-care control immunosuppression regimen of antibody induction, tacrolimus, mycophenolate, and corticosteroids.

FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells. This therapy induces or restores patients' immune tolerance by establishing stable donor chimerism in the transplant recipient without the need for life-long immunosuppression.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors
Actual Study Start Date: October 25, 2019
Estimated Primary Completion Date: April 2023
Estimated Study Completion Date: April 2026

Arms:
- Experimental: FCR001
- No Intervention: Control

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