NCT00498069

Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Harvest Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemia

Interventions

Type	Name	Description
DEVICE	Harvest Smartprep2 BMAC System	injection of 40cc bmac
DEVICE	SmartPReP2 BMAC System	Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System
BIOLOGICAL	placebo	injection of placebo into ischemic tissue of the lower extremity

Timeline

• Start date: 2007-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2007-07-09
• Last updated: 2015-03-19

Locations

6 sites across 1 country: United States