Stem Cell-Induced Immune Tolerance for Renal Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Stephan Busque, MD, MS

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if giving special cells from a kidney donor can help patients accept a new kidney without needing long-term medication. It targets patients receiving a kidney from a related donor. The treatment involves preparing the body and mixing donor and patient immune cells to prevent rejection.

Research Team

Stephan Busque, MD, MS

Principal Investigator

Stanford University

Eligibility Criteria

Adults aged 18-60 needing a kidney transplant with a related living donor who's a partial genetic match, or an unrelated donor matching at least two HLA antigens. Participants must consent to the study and use reliable contraception post-transplant. Exclusions include pregnant/nursing women, cancer history (except certain skin cancers), low blood counts, high antibody levels against donors, prior transplants, rabbit protein allergies, and certain infections.

Inclusion Criteria

My blood type matches the donor's.

I am not allergic to rabbit ATG or radiation treatments.

I am between 18 and 60 years old and have a matching living donor for a transplant.

Exclusion Criteria

Seronegative for Epstein-Barr virus if donor is seropositive

Leukopenia (white blood cell count < 3000/mm3) or thrombocytopenia (platelet count < 100,000/mm3)

My body has a high level of antibodies against a transplant.

Treatment Details

Interventions

• Donor Stem Cells (Other)

Trial Overview The trial is testing if stem cells from the kidney donor can help change the recipient's immune system so that they might eventually stop taking anti-rejection drugs. This involves patients receiving their relative's kidney plus stem cells to see if their body will accept the new organ without long-term medication.

Participant Groups

Group I: Immune Tolerance, Kidney transplantation Experimental Treatment 1 Intervention

Induction of immune tolerance in Haplotype matched living donor kidney transplantation.

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

Everett Meyer

Lead Sponsor

Trials

5

Recruited

150+

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