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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

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 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.

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.

Find a Location

Who is running the clinical trial?

Stephan BusqueLead Sponsor
Samuel Md Strober, MDStudy ChairStanford University
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Immune Tolerance
24 Patients Enrolled for Immune Tolerance

Media Library

Hematopoietic Cell Transplantation (Hematopoietic Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03591302 — Phase 1
Immune Tolerance Research Study Groups: Immune tolerance, Kidney transplantation
Immune Tolerance Clinical Trial 2023: Hematopoietic Cell Transplantation Highlights & Side Effects. Trial Name: NCT03591302 — Phase 1
Hematopoietic Cell Transplantation (Hematopoietic Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03591302 — Phase 1
~4 spots leftby Oct 2025
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