drugset / Trial / NCT01288053

Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease

NCT01288053 ↗

Phase 1/2 Terminated 9 enrolled Northwestern University
NaSingle-groupOpen-labelTreatment

Summary

Allogeneic transplantation has been a high-risk procedure, although non-myeloablative conditioning regimens (mini-transplantation) minimizes regimen related toxicity. The investigators, therefore, propose a phase I study of matched sibling allogeneic hematopoietic stem cell transplantation with non-myeloablative conditioning. In addition, graft versus host disease (GVHD) will be virtually eliminated by CAMPATH that removes donor T cells from the graft. The goal is to assess the toxicity/efficacy (phase I) of allogeneic non-myeloablative hematopoietic stem cell transplantation for high-risk Crohn's disease. In simplistic terms, this protocol is designed to ablate an aberrant immune system and then, similar to the use of marrow transplants for immunodeficient patients, reconstitute a new immune system with lymphocyte depleted marrow.

Timeline

Start
2010-01
Primary completion
2016-06
Completion
2016-06

Outcome

Outcome not reported

Stopped (Enrollment): “No participant enrolled more than two years. No plan to continue study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic Stem Cell Therapy Cell therapy — —

Indications