A Safety and Efficacy Study in Previously Transplanted Living Donor Kidney Recipients Following FCR001 Cell Therapy (FREEDOM-2)

Illinois, United States

Study Discontinued

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Overview

FREEDOM-2 is a clinical research study of an investigational cell therapy, called FCR001.  FCR001 is comprised of living stem cells obtained from the kidney donor. Stem cells are a unique kind of cell that can generate many other types of cell in the body. These cells are processed and infused in the kidney recipient. The cells then take up residence in the recipient’s bone marrow and generate new immune cells. The goal of FCR001 treatment is to create a “dual immune system” (part-donor and part-recipient) in the transplant recipient.

 

The purpose of this study is to assess the safety, efficacy, and overall benefit of FCR001 cell therapy in previously transplanted recipients of a kidney from a living donor.

 

Study activities include: Recipients 3-12 months post-living kidney transplantation undergo non-myeloablative conditioning followed by infusion of an enriched hematopoietic stem cell product derived from the same living donor’s peripheral blood stem cells.

 

You may be eligible for this study if:

    • You are 18 years and older
    • Have had a living donor kidney transplant
    • You are the recipient of a first kidney transplant from a living unrelated or non-HLA identical living related donor 3-12 months prior to signing informed consent
    • Your donor is between 18 and 60 years of age
    • You are not currently pregnant or nursing (lactating) woman

Other criteria will apply.

 

Locations:
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611