Kidney and Blood Stem Cell Transplantation That Eliminates Requirement for Immunosuppressive Drugs

StatusUnknown
PhasePhase 1/2
Started

Record status This record was last updated June 18, 2021 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jun 2021); last known: Active, Not Recruiting
  2. Primary and study completion dates: Jul 2021 to Jul 2026
    • Trial status: Active, Not Recruiting to Unknown
    v19
  3. Re-verified, no change to tracked fieldsv18
  4. Phase: Phase 1 to Phase 1/2
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: Immune tolerance (Device) to Hematopoietic cell transplantation (Biological), Total lymphoid irradiation (Radiation)
    • Site details revised
    v17
  5. Re-verified, no change to tracked fieldsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary and study completion dates: Jul 2016 to Jul 2021v15
  2. Re-verified, no change to tracked fieldsv14
  3. Primary and study completion dates: Jul 2015 to Jul 2016
    • Eligibility criteria shortened, about 7 words
    • Publications: 3 to 5
    • Study description expanded, about 3 words
    v13
  4. Primary endpoints: 3 to 1
    • Interventions: Kidney transplantation (Procedure) to Immune tolerance (Device)
    v12
  5. Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI) to Stanford University
    • Primary and study completion dates: Jul 2010 to Jul 2015
    • Collaborators expanded, about 7 words
    v11
  6. Primary and study completion dates: Jul 2009 to Jul 2010v10
  7. 2 versions Re-verified since Aug 7, 2008, no change to tracked fieldsv8-v9
  8. Primary endpoints revised (3)
    • Primary completion date: Jul 2009
    • Interventions: Blood Stem Cell Transplantation (Procedure), Kidney Transplantation (Procedure) to Kidney transplantation (Procedure)
    • Study arms: 0 to 1
    v7
  9. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v6
  10. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  11. Study completion date: Jul 2009v4
  12. Study description revised
    • Eligibility criteria shortened, about 1 word
    v3
  13. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone Marrow Transplantation are enrolling patients into a research study to determine if blood stem cells injected after kidney transplantation, in combination with lymphoid irradiation ,will change the immune system such that immunosuppressive drugs can be completely withdrawn. Patients must have a healthy, completely human leukocyte antigen (HLA)-matched brother or sister as the organ and stem cell donor. One to two months before kidney transplant surgery, blood stem cells will be removed from the donor and the cells will be frozen. After transplant surgery, the recipient will receive radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the stem cells. The stem cells will be injected at the end of the two-week treatment. If the stem cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation. Patients will be followed in the Stanford clinics for transplant patients. Patients who live outside of the San Francisco Bay Area must remain near Stanford for six weeks after transplant surgery.
Trial Details
NCT Number NCT00319657
Lead Sponsor Stanford University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Immune Tolerance
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov