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

Launched by STANFORD UNIVERSITY · May 7, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to help patients who receive a kidney from a living donor. The researchers want to find out if a special treatment plan that includes radiation, specific medications, and a type of immune cell infusion can help patients stop taking anti-rejection drugs after their transplant. Anti-rejection drugs are usually needed to prevent the body from rejecting the new kidney, so finding a way to reduce or discontinue them could make life easier for kidney transplant recipients.

To participate in this study, you need to be an adult between 18 and 65 years old who is receiving a kidney from a living donor and has a specific match with that donor. You also need to be willing to sign consent forms and meet certain health criteria. If you join the trial, you will receive the new treatment and be closely monitored to see how well it works. This could be an exciting opportunity for those looking for advancements in kidney transplantation!

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.