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Hematopoietic Cell Transplantation

Kidney + Stem Cell Transplant for Immune Tolerance

Phase 1 & 2

Waitlist Available

Led By Samuel Strober, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Have an HLA-matched sibling donor

No known contraindication to administration of rabbit ATG or radiation

Must not have

Previous treatment with rabbit ATG or a known allergy to rabbit proteins

cPRA>80%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether blood stem cells, when injected after kidney transplantation and combined with lymphoid irradiation, will change the immune system such that immunosuppressive drugs can be completely withdrawn.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions to radiation and anti-T cell antibodies like fatigue and nausea; risks associated with stem cell injections such as infection; complications from reducing immunosuppressive drugs which may lead to organ rejection or immune system disorders.

Eligibility Criteria

Inclusion Criteria

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

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

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I am not allergic to rabbit ATG or radiation treatments.

Exclusion Criteria

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

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

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

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I am not infected with HIV, Hepatitis B, or Hepatitis C.

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I have had cancer before, but not skin cancer.

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I have had an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Discontinuation of maintenance immunosuppressive drugs

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total lymphoid irradiation

2009

Completed Phase 3

~60

0 / 7Eligibility criteria met