Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jeffrey Veale, MD
Study ID
NCT03707262
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Kidney Transplant
  • Renal Transplant Rejection
  • Tolerance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Donor CD34+ and CD3+ cells — BIOLOGICAL
    Infusion of GCSF-mobilized, Miltenyi-enriched CD34+ hematopoietic stem/progenitor cells (HSPCs) (≥ 5 million cells/kg) and CD3+ cells (5 million cells/kg) from an HLA-identical sibling living donor, following pre-conditioning regimen of rATG and TLI.

Study Details

The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor. The investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as "mixed chimerism." Mixed chimerism may help create a state of "tolerance" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney. This study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.

Key Dates

Start date
Nov 6, 2019
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Donor CD34+ and CD3+ cell infusion
    The investigational products are (1) an intravenous infusion of granulocyte colony-stimulating factor (GCSF)-mobilized, Miltenyi-enriched CD34+ cells (≥ 5 million cells per kilogram) followed by (2) an infusion of CD3+ cells (5 million cells per kilogram) from an HLA-identical sibling living donor. The cells are infused around Day 11 post-transplant after the following pre-conditioning regimen: 1. 5 doses of rATG (1.5 mg/kg IV per day for 5 days, starting on the day of transplant) 2. 10 doses of TLI (120 centigray \[cGY\] x 10 fractions, starting the day after transplant)

Primary Outcome Measure

Withdrawal from immunosuppressive drugs [ Time Frame: 12 months post-kidney transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Dana Levin, MPH
[email protected]
310-794-8893
Jenny Lester, MPH
[email protected]
310-794-9728
Jeffrey Veale, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, Los Angeles· Los Angeles, CA

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