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Stem Cell-Induced Immune Tolerance for Renal Disease
Phase 1
Waitlist Available
Led By Stephan Busque, MD,MS
Research Sponsored by Stanford University
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
Must not have
Panel Reactive Antibody greater than 80% or demonstration of donor specific antibody (DSA)
History of malignancy excluding non-melanoma skin malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years and indefinitely if possible
Awards & highlights
Summary
This trial tests if giving special cells from a kidney donor can help patients accept a new kidney without needing long-term medication. It targets patients receiving a kidney from a related donor. The treatment involves preparing the body and mixing donor and patient immune cells to prevent rejection.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My body has a high level of antibodies against a transplant.
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I have had cancer before, but not skin cancer.
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I have had an organ transplant.
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I am at high risk for my kidney disease coming back, but it's not FSGS.
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I have been treated with rabbit ATG or am allergic to rabbit proteins.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years and indefinitely if possible
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years and indefinitely if possible
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for renal disease, particularly those involving immune system modulation, include plasmapheresis, immunosuppressive therapy, and stem cell transplantation. Plasmapheresis removes harmful antibodies from the blood, reducing immune-mediated kidney damage.
Immunosuppressive drugs like cyclophosphamide and prednisone suppress the immune system to prevent further damage. Stem cell transplantation aims to reset the immune system, potentially reducing the need for long-term immunosuppression.
These treatments are vital for renal disease patients as they address the underlying immune mechanisms causing kidney damage, thereby improving kidney function and patient outcomes.
Therapies Targeting Epigenetic Alterations in Acute Kidney Injury-to-Chronic Kidney Disease Transition.
Therapies Targeting Epigenetic Alterations in Acute Kidney Injury-to-Chronic Kidney Disease Transition.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,905 Previous Clinical Trials
47,837,632 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,457 Previous Clinical Trials
17,494,720 Total Patients Enrolled
Everett MeyerLead Sponsor
4 Previous Clinical Trials
122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My body has a high level of antibodies against a transplant.I have had cancer before, but not skin cancer.My blood type matches the donor's.I am not allergic to rabbit ATG or radiation treatments.I am between 18 and 60 years old and have a matching living donor for a transplant.I have had an organ transplant.I am at high risk for my kidney disease coming back, but it's not FSGS.I agree to use birth control for 2 years after my transplant.I have been treated with rabbit ATG or am allergic to rabbit proteins.
Research Study Groups:
This trial has the following groups:- Group 1: Immune Tolerance, Kidney transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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