NCT01049919

Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)

MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).

Detailed description

This is a prospective, randomized, double-blind, placebo controlled, multicenter trial intended for subjects with critical limb ischemia (CLI) that are unsuitable for revascularization. The investigational treatment utilizes autologous concentrated bone marrow aspirate (cBMA) at the point of care. The bone marrow aspirate is obtained from the subject's hip, concentrated with a bone marrow concentration device, and delivered intramuscularly to the affected limb. Subjects meeting the inclusion/exclusion criteria will be randomized to receive either the investigational treatment (cBMA) or a placebo control (sham treatment).

Conditions

• Critical Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Bone marrow concentration device	Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
PROCEDURE	Placebo procedure (sham)	Sham bone marrow aspiration, sham delivery to affected limb

Timeline

• Start date: 2010-06-01
• Primary completion: 2016-06-01
• Completion: 2020-02-01
• First posted: 2010-01-15
• Last updated: 2021-05-28
• Results posted: 2021-05-28

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study