drugset / Trial / NCT02150551

Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease

NCT02150551 ↗

Phase 1 Completed 1 enrolled Catherine Bollard
NaSingle-groupOpen-labelTreatment

Summary

In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies. The goals of this study are to test the safety and tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease. Mesenchymal stromal cells support the development of blood cells within the bone marrow. When isolated from a donor and infused into an animal or human, they have been demonstrated to travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection. These properties lead investigators to hypothesize that that these may be they may be beneficial in treating inflammatory bowel disease.

Timeline

Start
2018-06-07
Primary completion
2018-09-05
Completion
2018-09-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic bone marrow-derived mesenchymal stromal cells Cell therapy 1e+06 cells/kg Intravenous