Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stephan Busque
Study ID
NCT03591302
Phase
PHASE1
Status
Recruiting
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Conditions

  • Immune Tolerance

Eligibility Criteria

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

Interventions

  • Hematopoietic cell transplantation — BIOLOGICAL
    Transplantation of hematopoietic stem cells from living donor.
  • Total Lymphoid irradiation — RADIATION
    Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.

Study Details

The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Key Dates

Start date
Feb 2, 2024
Status verified
Jun 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

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

Arms

  • Experimental: Immune tolerance, Kidney transplantation
    Intervention: HLA matched living donor recipients of a functioning kidney transplant graft at one year will receive hematopoietic cell transplantation and Total lymphoid irradiation. The intervention is intended to induce immune tolerance such as to allow withdrawal of the immunosuppressive drugs. Immune tolerance is achieved through the development of donor/recipient mixed chimerism following combined kidney and hematopoietic stem cell transplantation from the living donor.

Primary Outcome Measure

Percentage of patients no longer dependent on immunosuppressive drugs to maintain normal renal function. [ Time Frame: six months to up to five years post stem cell transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94304
Stephan Busque, MD MS
[email protected]
6504986189
John Scandling, MD (SUB_INVESTIGATOR)
Everett Meyer, MD (PRINCIPAL_INVESTIGATOR)
Robert Lowsky, MD (PRINCIPAL_INVESTIGATOR)
Hoppe Richard, MD (SUB_INVESTIGATOR)
Thomas A Pham, MD (SUB_INVESTIGATOR)
Stephan Busque, MD (PRINCIPAL_INVESTIGATOR)
Colin Lenihan, MD (SUB_INVESTIGATOR)
Michael Binkley, MD (SUB_INVESTIGATOR)
Kevin Sheehan, PhD (SUB_INVESTIGATOR)
Subramanian Sivarajan, MD (SUB_INVESTIGATOR)
Marc L Melcher, MD (SUB_INVESTIGATOR)

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By research site
Stanford University Medical Center· Palo Alto, CA

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