Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)

PHASE3CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

August 31, 2015

Study Completion Date

November 30, 2015

Conditions
Critical Limb Ischemia
Interventions
DEVICE

BMAC injection

Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System

DEVICE

Placebo injection

Injection of placebo into ischemic tissue of the lower extremity

Trial Locations (34)

10025

St. Luke's Roosevelt, New York

11042

North Shore-Long Island Jewish, Lake Success

21287

Johns Hopkins Hospital, Baltimore

25304

Charleston Area Medical Center Institute, Charleston

27157

Wake Forest Baptist Health, Winston-Salem

27599

University of North Carolina at Chapel Hill, Chapel Hill

29401

Roper St Francis Medical Center, Charleston

29615

Greenville Health System, Greenville

32503

Coastal Vascular & Interventional, Pensacola

32804

Florida Hospital - Vascular Institute of Central Florida, Orlando

33606

USF / Tampa General, Tampa

37920

University of Tennessee, Knoxville

45267

University of Cincinnati, Cincinnati

45801

Regional Infectious Disease and Infusion Ctr, Lima

60190

Cadence Health, Central DuPage Hospital, Winfield

60612

University of Illinois-Chicago, Chicago

63141

Mercy Hospital, St Louis

64116

Kansas City Vascular, Kansas City

70121

Ochsner Clinic, New Orleans

71730

Medical Center of South Arkansas, El Dorado

74135

University of Oklahoma, Tulsa

75226

Baylor Medical Ctr, Dallas

77030

University of Texas - Houston Medical School, Houston

90033

USC Keck School of Medicine, Los Angeles

97239

Oregon Health Science University, Portland

98682

Peace Health Southwest Medical Center, Vancouver

35294-0012

University of Alabama, Birmingham

04102

Maine Medical Ctr, Portland

02111

Tufts Medical Center, Boston

02215

Beth Israel Deaconess, Boston

03756

Dartmouth Hitchcock Medical Ctr, Lebanon

08103

Cooper University Hospital, Camden

07666

Holy Name Medical Center, Teaneck

02903

Rhode Island Hospital, Providence

Sponsors
All Listed Sponsors
lead

Harvest Technologies

INDUSTRY