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

Conditions

• Living Donor Kidney Transplantation

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs — BIOLOGICAL
  Living donor kidney transplant recipients will receive after a preparatory regimen of total lymphoid irradiation, total body irradiation and anti-thymocyte globulin an infusion of purified donor CD34+ of \>10 x10\^6 cells /Kg, 100 x 10\^6 donor T cell/ Kg and and an escalated dose of recipient Tregs starting at 25 x10\^6/Kg.

Study Details

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.

Key Dates

Start date

Feb 1, 2020

Status verified

Jun 2026

Primary completion

Nov 1, 2029

Completion

Dec 1, 2029

Study Design

Enrollment

22 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Count of participants with sustained mixed chimerism of >25% at 18 months [ Time Frame: Month 18 ]

Central Contacts

• Kevin Ly, BS
  650-497-6057
  [email protected]
• Stephan Busque, MD
  650-498-6189
  [email protected]

Locations (2)

Find similar trials in Palo Alto, CA