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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year to five years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year to five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year to five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Percentage of patients experiencing biopsy proven rejection episodes requiring treatment requiring corticosteroids.

Percentage of patients experiencing graft loss.

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 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health risks have been identified with Total Lymphoid irradiation?

"Due to the limited data on safety and efficacy, our experts at Power rated Total Lymphoid Irradiation a 1 out of 3."

Answered by AI

How many participants are currently enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research project is searching for 25 participants across a single location and was recently updated on May 6th 2022 since its initial post date of September 13th 2018."

Answered by AI

Are there still openings available for prospective participants in this experiment?

"According to the data hosted on clinicaltrials.gov, this medical study is actively recruiting participants. It was first posted in September 2018 and its latest amendment occurred in May 2022."

Answered by AI