Kidney + Stem Cell Transplant for Immune Tolerance

Recruiting in Palo Alto (17 mi)

Overseen by Samuel Strober, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone Marrow Transplantation are enrolling patients into a research study to determine if blood stem cells injected after kidney transplantation, in combination with lymphoid irradiation ,will change the immune system such that immunosuppressive drugs can be completely withdrawn. Patients must have a healthy, completely human leukocyte antigen (HLA)-matched brother or sister as the organ and stem cell donor. One to two months before kidney transplant surgery, blood stem cells will be removed from the donor and the cells will be frozen. After transplant surgery, the recipient will receive radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the stem cells. The stem cells will be injected at the end of the two-week treatment. If the stem cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation. Patients will be followed in the Stanford clinics for transplant patients. Patients who live outside of the San Francisco Bay Area must remain near Stanford for six weeks after transplant surgery.

Research Team

Samuel Strober, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for kidney transplant patients at Stanford who have a healthy sibling with matching human leukocyte antigens (HLA). Participants must not have HIV, Hepatitis B or C, low white blood cell or platelet counts, high antibody levels against transplants, a history of cancer (except certain skin cancers), previous organ transplants, or allergies to rabbit proteins. They should agree to use reliable contraception for two years post-transplant.

Inclusion Criteria

I agree to use birth control for at least 24 months after my transplant.

I have a sibling who is a perfect match for a donation.

Kidney transplant performed at Stanford University Medical Center

Exclusion Criteria

I have been treated with rabbit ATG or am allergic to rabbit proteins.

Thrombocytopenia (platelet count less than 100,000/mm³)

My immune system is highly likely to reject a transplanted organ.

Treatment Details

Interventions

• Hematopoietic Cell Transplantation (Hematopoietic Cell Transplantation)
• Total Lymphoid Irradiation (Radiation)

Trial Overview The study tests if injecting the patient with their HLA-matched sibling's blood stem cells after kidney transplantation and lymphoid irradiation can eliminate the need for lifelong immunosuppressive drugs. The process involves pre-transplant donor cell collection, post-surgery radiation and anti-T cell treatment before stem cell injection. If successful, drug withdrawal starts six months later.

Participant Groups

Group I: Immune tolerance, kidney transplantation Experimental Treatment 2 Interventions

Intervention: Participants will receive hematopoietic cell transplantation and Total lymphoid irradiation. The intervention is intended to induce immune tolerance in HLA-matched living donor kidney transplantation, to allow withdrawal of the immunosuppressive drugs. Immune tolerance is achieved through the development of donor/recipient mixed chimerism following combined kidney and hematopoietic stem cell transplantation from the living donor.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco