Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJeffrey Veale, MD
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Donor CD34+ and CD3+ cells
Biological/VaccineInfusion of GCSF-mobilized, Miltenyi-enriched CD34+ hematopoietic stem/progenitor cells (HSPCs) (≥ 5 million cells/kg) and CD3+ cells (5 million cells/kg) from an HLA-identical sibling living donor, following pre-conditioning regimen of rATG and TLI.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Donor CD34+ and CD3+ cell infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Withdrawal from immunosuppressive drugs
Percentage of subjects free from all immunosuppressive drugs at 12 months after kidney transplantation.
Time frame
12 months post-kidney transplantSecondary outcomes
1
Graft rejection
Percentage of patients with graft rejection within 48 months post-transplant defined as (1) meets Banff criteria for rejection either on protocol biopsy or biopsy performed to confirm clinical suspicion of rejection or (2) clinical suspicion of rejection demonstrating response to corticosteroids in absence of biopsy when confirmatory biopsy contraindicated or declined.
Time frame
48 months post-kidney transplant2
Time to graft rejection
Time to graft rejection
Time frame
48 months post-kidney transplant3
Graft failure
Percentage of patients with graft failure as determined by return to dialysis and/or re-transplantation.
Time frame
48 months post-kidney transplant4
Time to graft failure
Time to graft failure
Time frame
48 months post-kidney transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jeffrey Veale, MD
Lead sponsor
University of California, Los Angeles
Sponsor institution
OneLegacy Foundation
Collaborator
Source ClinicalTrials.gov