An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Enriched Hematopoietic Stem Cell Infusion
Northwestern Memorial Hospital
Chicago, Illinois, United States
Duke University
Durham, North Carolina, United States
Enriched Hematopoietic Stem Cell Engraftment
Time frame: One month to three years
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