About this trial
The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor.
The investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as "mixed chimerism." Mixed chimerism may help create a state of "tolerance" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney.
This study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.
Eligibility criteria
Qualifiers
Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center.
Agrees to participate in the study and is able to give informed consent.
Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion.
Meets institutional criteria for kidney and HSPC transplant.
Disqualifiers
Donor is identical twin.
ABO incompatibility with donor.
Previous solid organ transplant
Multi-organ transplantation
Trial design
Treatments tested in this trial
- Donor CD34+ and CD3+ cells
Treatment groups
Sponsors and collaborators
Jeffrey Veale, MD
Lead sponsor
University of California, Los Angeles
Sponsor institution
OneLegacy Foundation
Collaborator