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

NATerminatedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

June 30, 2016

Study Completion Date

February 29, 2020

Conditions
Critical Limb IschemiaPeripheral Arterial DiseasePeripheral Vascular Disease
Interventions
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

Trial Locations (25)

10029

The Mount Sinai Hospital, New York

10065

Weill Cornell Medical College / New York-Presbyterian Hospital, New York

15240

VA Pittsburgh Healthcare System, Pittsburgh

19140

Temple University Hospital, Philadelphia

22908

University of Virginia Hospital, Charlottesville

30309

Piedmont Hospital, Atlanta

33136

University of Miami, Miami

40202

University of Louisville, Louisville

43215

Remington-Davis, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

The Cleveland Clinic, Cleveland

46202

Indiana University School of Medicine, Indianapolis

49503

Spectrum Health, Grand Rapids

52242

University of Iowa Hospitals and Clinics, Iowa City

53215

Aurora St. Luke's Medical Center, Milwaukee

60611

Northwestern University, Chicago

64111

Saint Luke's Hospital, Kansas City

68105

Nebraska-Western Iowa VA Healthcare System, Omaha

72205

Central Arkansas Veterans Healthcare System, Little Rock

77030

The Methodist Hospital, Houston

95817

University of California-Davis Medical Center, Sacramento

99204

Providence Sacred Heart Medical Center, Spokane

02111

Tufts Medical Center, Boston

01655

UMass Memorial Health Care, Worcester

07666

Holy Name Medical Center, Teaneck

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Zimmer Biomet

INDUSTRY