drugset / Trial / NCT04804891

Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal Transplantation

NCT04804891 ↗

Phase 1 Recruiting 6 enrolled Columbia University Ossium Health, Inc. · collab
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to investigate the safety and feasibility of giving intestinal transplant patients CD34+ stem cells (the cells that make all the types of blood cells) obtained from their organ donor's bone marrow. The goal of this is to develop a post-transplant treatment strategy that controls rejection while reducing the high risk of infection and malignant disease associated with the high levels of immunosuppression medication(s) that intestinal and multi-organ transplant patients must take. Infusion of bone marrow cells from the same donor of the transplanted organ(s) could promote a state called "mixed chimerism" in which both donor cells and recipient cells coexist in the body with the ultimate goal of minimizing the amount of immunosuppression medication(s) needed.

Timeline

Start
2021-10-22
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CD34+ cells Cell therapy 1e+06 cells/kg —

Indications

No indication recorded.