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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

• Patients who agree to participate in the study and sign an Informed Consent.

• Patients who have no known contraindication to administration of rabbit ATG or radiation.

• Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant

Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Illinois
Nothwestern University
RECRUITING
Chicago
Contact Information
Primary
Kevin Ly, BS
kevinly@stanford.edu
650-497-6057
Backup
Stephan Busque, MD
sbusque@stanford.edu
650-498-6189
Time Frame
Start Date: 2020-02-01
Estimated Completion Date: 2024-10-01
Participants
Target number of participants: 22
Treatments
Experimental: Combined kidney/stem cell transplants and recipient's Tregs
Preparatory regimen including TLI, TBI, ATG after kidney transplantation followed by infusion of donor CD34+, T cell and recipient Tregs
Authors
Lowsky Robert
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern University, California Institute for Regenerative Medicine (CIRM)
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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