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Stem Cell-Induced Immune Tolerance for Renal Disease

Phase 1
Waitlist Available
Led By Stephan Busque
Research Sponsored by Everett Meyer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consenting adults aged 18 to 60 who are living donor transplant candidates with a haplotype related living donor or > 2 HLA antigen matched, unrelated living donor (including at least one HLA-DR antigen match plus at least one antigen match of either HLA-A or HLA-B)
ABO compatible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years and indefinitely if possible
Awards & highlights

Study Summary

This trial is testing whether or not donor stem cells can be used to allow patients to stop taking immunosuppressive drugs after a kidney transplant.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions to rabbit-derived ATG or radiation used in treatment, increased risk of infection due to immunosuppression changes after transplant and stem cell infusion, as well as possible complications from long-term drug withdrawal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old and have a matching living donor for a transplant.
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My blood type matches the donor's.
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I am not allergic to rabbit ATG or radiation treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years and indefinitely if possible
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years and indefinitely if possible for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long term freedom from transplant immunosuppressive drugs, safety, rate of infection, graft survival and patient survival.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Immune Tolerance, Kidney transplantationExperimental Treatment1 Intervention
Induction of immune tolerance in Haplotype matched living donor kidney transplantation.

Find a Location

Who is running the clinical trial?

Everett MeyerLead Sponsor
4 Previous Clinical Trials
122 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,850 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,902 Total Patients Enrolled

Media Library

Immune Tolerance Clinical Trial Eligibility Overview. Trial Name: NCT01165762 — Phase 1
Renal Disease Research Study Groups: Immune Tolerance, Kidney transplantation
Renal Disease Clinical Trial 2023: Immune Tolerance Highlights & Side Effects. Trial Name: NCT01165762 — Phase 1
Immune Tolerance 2023 Treatment Timeline for Medical Study. Trial Name: NCT01165762 — Phase 1

Frequently Asked Questions

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

Is Immune Tolerance a perilous practice to pursue?

"The safety of Immune Tolerance was deemed a 1 out of 3, due to the early phase nature of this study indicating limited data available on its efficacy and safety."

Answered by AI

Is the age cap for this clinical trial set at forty or below?

"This clinical trial accepts participants between the ages of 18 and 60 in accordance with its inclusion criteria."

Answered by AI

Is enrollment available for this research project?

"According to clinicaltrials.gov, the current recruitment for this medical trial has ended; posted on 14th July 2010 and last edited 30th June 2022. Nonetheless, 11 other clinical trials are still recruiting patients at this time."

Answered by AI

Is there an opportunity for me to take part in this investigation?

"This clinical trial aims to enrol 25 individuals with end-stage renal disease who are between 18 and 60 years old. Crucially, qualified applicants must have a haplotype compatible living donor or two HLA antigen matched unrelated donors (including one HLA-DR antigen match plus either an HLA-A or B antigen match), agree to use contraception for 24 months post transplant, and be ABO compatible."

Answered by AI
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~0 spots leftby Jun 2024