Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 11:51 AM
Study NCT ID:
NCT00498069
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2007-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)
Sponsor:
Harvest Technologies
Organization:
Study Overview
Official Title:
Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis
Detailed Description:
Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The buffy coat is concentrated by removing plasma. The resultant concentrate of cells is injected into ischemic tissues of the lower limb.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: