Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment
NCT04571203 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-05-11
Summary
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.
Conditions
- Immune Tolerance
Interventions
- BIOLOGICAL
-
Combined Deceased Donor Kidney and Hematopoietic Cell Transplants
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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Robert Lowsky, MD · Stanford University
-
Stephan Busque, MD · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-06
- Primary Completion
- 2025-10-01
- Completion
- 2029-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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