What side effects are associated with this type of intervention?

Common treatments for renal disease, especially those involving immune system modulation like donor stem cells, often include immunosuppressive therapies. These treatments can lead to side effects such as increased risk of infections, liver enzyme elevation, pancreatitis, bone marrow suppression, and serious adverse events like severe infections or hospitalization. Plasmapheresis, another treatment used to remove circulating antibodies, can cause complications such as bleeding, infection, and low blood pressure.

What prior FDA approvals exist?

FDA-approved treatments for renal disease have traditionally focused on immunosuppressive therapies to prevent rejection in kidney transplant recipients. Commonly used drugs include mycophenolate mofetil, azathioprine, and cyclophosphamide, often combined with corticosteroids like prednisone. These treatments aim to modulate the immune system to prevent graft rejection. While the use of donor stem cells for immune system modulation is still under investigation, it represents a novel approach that could potentially reduce the need for long-term immunosuppressive drugs.

What other types of research exist?

Promising novel alternatives to donor stem cells for renal disease patients include: 1) Plasmapheresis combined with immunosuppressive therapy (e.g., cyclophosphamide, rituximab) for conditions like anti-GBM disease. 2) Use of rituximab or mycophenolate mofetil (MMF) as alternatives to cyclophosphamide in recurrent or relapsing cases. 3) Mesenchymal stem cells, particularly umbilical cord-derived, which have shown potential in treatment-refractory systemic lupus erythematosus nephritis. These therapies offer new avenues for managing renal diseases and modulating the immune system.

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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

No Placebo-Only Group

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 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.

Exclusion Criteria

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

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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

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

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.

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 Treatment1 Intervention

Induction of immune tolerance in Haplotype matched living donor kidney transplantation.

0 / 8Eligibility criteria met

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.