Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04571203
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Immune Tolerance

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Combined Deceased Donor Kidney and Hematopoietic Cell Transplants — BIOLOGICAL
    This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.

Study Details

This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.

Key Dates

Start date
May 6, 2022
Status verified
May 2022
Primary completion
Oct 1, 2025
Completion
Oct 1, 2029

Study Design

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

Arms

  • Experimental: Phase I Study of Combined DD Kidney and HCT Transplant
    Single arm Phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion

Primary Outcome Measure

Number of patients out of the total patients enrolled who received both the kidney and the bone marrow from the same donor. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-

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By research site
Stanford University· Palo Alto, CA

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