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Hematopoietic Stem Cell Transplantation

Hematopoietic Cell Transplantation for Immune Tolerance in Kidney Transplant Recipients

Phase 1

Recruiting

Research Sponsored by Stephan Busque

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have no known contraindication to the administration of rabbit ATG or radiation

The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford

Must not have

Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease, or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1

Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months to up to five years post stem cell transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if patients with a functioning kidney transplant and a matching donor can discontinue immunosuppressive drugs while maintaining normal renal function.

Who is the study for?

Adults over 18 with a functioning kidney transplant from an HLA-matched sibling for at least one year, who wish to stop taking immunosuppressive drugs. Participants must have no history of rejection, agree to use reliable contraception, and their donor must also consent and meet criteria for stem cell donation.

What is being tested?

The trial is testing if Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG), followed by an infusion of donor hematopoietic progenitor cells can allow patients to safely discontinue immunosuppressive medications while maintaining normal kidney function.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation or allergies due to ATG or radiation therapy, potential blood disorders like leukopenia or thrombocytopenia, and general risks associated with bone marrow transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not allergic or sensitive to rabbit ATG or radiation treatments.

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My donor and I are a complete HLA match according to Stanford's lab.

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I am over 18, had a kidney transplant from a sibling, and my donor is still available without any history of rejection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney biopsy shows rejection, disease recurrence, or significant scarring.

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I have had a kidney transplant rejected or my original kidney disease came back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months to up to five years post stem cell transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months to up to five years post stem cell transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months to up to five years post stem cell transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients no longer dependent on immunosuppressive drugs to maintain normal renal function.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Immune tolerance, Kidney transplantationExperimental Treatment2 Interventions

Intervention: HLA matched living donor recipients of a functioning kidney transplant graft at one year will receive hematopoietic cell transplantation and Total lymphoid irradiation. The intervention is intended to induce immune tolerance such as 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.

0 / 5Eligibility criteria met