Clinical Trial: Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies

Brief Summary: The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with hemoglobinopathies.

Detailed Summary: This proposal is a phase I/II feasibility study to demonstrate that mixed chimerism can be established with minimal risk in recipients with hemoglobinopathies treated with Campath-1H-based nonmyeloablative conditioning and graft engineering to reduce the risk of Graft Versus Host Disease (GVHD), but preserve engraftment of donor cells.
Sponsor: University of Louisville

Current Primary Outcome: Proportion of Hemoglobin A and S [ Time Frame: one month to three years ]

Red blood cell contents by hemoglobin electrophoresis


Original Primary Outcome: Bone Marrow Engraftment,Chimerism and No Evidence of Graft-versus-Host-Disease [ Time Frame: From thirty days to three years ]

Current Secondary Outcome: Enriched Hematopoetic Stem Cell Engraftment [ Time Frame: One month to three years ]

Original Secondary Outcome:

Information By: University of Louisville

Dates:
Date Received: October 20, 2008
Date Started: January 2005
Date Completion: May 2030
Last Updated: March 31, 2017
Last Verified: March 2017