Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01419704
Status:
WITHDRAWN
Last Update Posted:
2023-03-03
First Post:
2011-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies
Sponsor:
Talaris Therapeutics Inc.
Organization:
Study Overview
Official Title:
Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study completed at site, no active participants.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with hemoglobinopathies.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: