Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease

swisstolerance.ch

This pilot study of combined kidney and hematopoietic stem cell transplantation attempts to establish a protocol to induce immunological tolerance as a new strategy to prevent renal graft rejection. If successful, this strategy would restore renal function, while avoiding the risks associated with long-term standard anti-rejection therapy, and would represent the first option to cure end-stage renal disease.

2015-09-01

2024-12-01

2025-12-01

Recruiting

16

Inclusion Criteria: * Patients, who are eligible for kidney transplantation * Males or females 18 - 70 years of age. * Subjects must have an HLA-matched sibling donor 25-70 years of age * Men and women of reproductive potential must agree to use a reliable method of birth control * Ability to understand and provide informed consent. Exclusion Criteria: * Evidence of uncontrolled active infection (including replicating HIV, Hepatitic B and Hepatitis C) as defined by: 1. clinical syndrome consistent with viral or bacterial infection, or 2. fever with a clinical site of infection identified, or 3. microbiologically documented infection * Contraindication to therapy with any one of the proposed agents (e.g. allergy to ATG). * Serologic positivity to HIV. * Women of childbearing age in whom adequate contraception cannot be maintained, pregnant women or nursing mothers. * Malignancy within the past two years, for which waiting time for transplantation is required by PENN registry consult, thereby excluding non-melanoma skin cancer and carcinoma in situ of the cervix. * Liver transaminases \> 3 x normal value. * Cardiac ejection fraction \< 50% by radionuclide ventriculography or echocardiography. * Forced Expiratory Volume (FEV1) \< 50% predicted or corrected Diffusing Capacity for Carbon Monoxide (DLCO) \< 50 % predicted. * Blood group incompatibility in the host-vs-graft direction. * High risk of primary kidney disease recurrence

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2023-12-01