TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

Description

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.

Conditions

Living Donor Kidney Transplantation

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Study Overview

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Study Details

Study overview

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.

Phase 1 Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation

TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

Condition
Living Donor Kidney Transplantation
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94305

Chicago

Nothwestern University, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
  • 2. Patients who agree to participate in the study and sign an Informed Consent.
  • 3. Patients who have no known contraindication to administration of rabbit ATG or radiation.
  • 4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant
  • 1. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
  • 2. History of malignancy with the exception of non-melanoma skin malignancies.
  • 3. Pregnant women or nursing mothers.
  • 4. Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
  • 5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
  • 6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
  • 7. Prior organ transplantation
  • 8. High risk of primary kidney disease recurrence
  • 9. Advanced coronary or vascular disease.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Everett Meyer, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

2024-10-01