An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)

PHASE3CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

March 25, 2014

Study Completion Date

March 25, 2014

Conditions
Critical Limb Ischemia
Interventions
BIOLOGICAL

Ixmyelocel-T

On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.

OTHER

Placebo

On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.

Trial Locations (86)

10029

Mount Sinai Medical Center, New York

11794

Stony Brook University Medical Center, Stony Brook

14203

University of Buffalo Surgeons Inc., Buffalo

15212

Allegheny General Hospital, Pittsburgh

15232

Veterans' Administration Medical Center, Pittsburgh

15240

VA Pittsburgh Healthcare System, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

19140

Temple University Hospital, Philadelphia

21201

University of Maryland Medical Center, Baltimore

21218

Union Memorial Hospital, Baltimore

25304

Charleston Area Medical Center - Memorial Hospital, Charleston

27157

Wake Forest Baptist Health, Winston-Salem

27599

University of North Carolina Hospital, Chapel Hill

27710

Duke University Medical Center, Durham

30060

Vascular Surgical Associates, P.C., Marietta

32216

First Coast Cardiovascular Institute, P.A., Jacksonville

32501

Baptist Hospital, Pensacola

Cardiology Consultants, Pensacola

32605

Florida Research Network, LLC, Gainesville

32608

Malcom Randall Veterans Affairs Medical Center, Gainesville

32806

Orlando Health, Orlando

32960

Grove Place Surgery Center, Vero Beach

33136

University of Miami Hospital, Miami

33308

Holy Cross Hospital, Fort Lauderdale

33435

Bethesda Memorial Hospital - Clinical Research Center, Boynton Beach

35211

Cardiology PC, Birmingham

35243

Cardio-Thoracic Surgeons, P.C., Birmingham

35294

University Of Alabama At Birmingham, Birmingham

37212

Vanderbilt University Medical Center, Nashville

39401

Hattiesburg Clinic, P.A., Hattiesburg

43606

Jobst Vascular Institute, Toledo

43614

University of Toledo Medical Center, Toledo

44106

University Hospitals Case Medical Center, Cleveland

46290

St. Vincent Medical Group, Inc., Indianapolis

46804

Indiana/Ohio Heart, Fort Wayne

48072

Cardiology and Vascular Associates, P.C., Berkley

48105

VA Ann Arbor Healthcare System, Ann Arbor

48124

Oakwood Hospital and Medical Center, Dearborn

48197

Saint Joseph Mercy Hospital, Ypsilanti

48201

John D. Dingell VA Medical Center, Detroit

48202

Henry Ford Hospital, Detroit

48439

Integrated Vascular Vein Center of Michigan, Grand Blanc

48507

Michigan Vascular Research Center, Flint

48602

Michigan CardioVascular Institutue at Covenant Medical Center, Saginaw

50324

Heartland Vascular Medicine and Surgery, Windsor Heights

53203

Medical College of Wisconsin, Milwaukee

53211

Columbia Saint Mary's, Milwaukee

53217

Wheaton Franciscan Medical Group, Inc., Milwaukee

53792

University of Wisconsin, Madison

55407

Abbott Northwestern Hospital / Minneapolis Heart Institute-Vascular Clinic, Minneapolis

55417

Minneapolis VA Health Care System, Minneapolis

55455

University of Minnesota Medical School, Minneapolis

60612

Rush University Medical Center, Chicago

University of Illinois at Chicago - Clinical Sciences North, Chicago

62702

Memorial Medical Center, Springfield

64111

Saint Luke's Hospital, Kansas City

68105

Omaha VAMC, Omaha

70121

Ochsner Clinic foundation, New Orleans

72204

Arkansas Primary Care Clinic, P.A., Little Rock

72205

Central Arkansas Veteran's Healthcare System, Little Rock

73104

University of Oklahoma Health Science Center, Oklahoma City

75208

DFW Vascular Group, LLP, Dallas

77030

Texas Heart Institute at St. Luke's Episcopal Hospital, Houston

The Methodist Hospital, Houston

78229

Audie L Murphy VA Hospital - Pathology Laboratory, San Antonio

80045

University of Colorado Denver - Anschutz Medical Campus, Aurora

84132

University of Utah, Salt Lake City

85006

Arizona Heart Institute, Phoenix

85012

Carl T. Hayden VA Medical Center, Phoenix

85724

University of Arizona, Tucson

90095

UCLA Gonda Venous Center & Ambulatory Procedure Unit, Los Angeles

92103

University of California San Diego Medical Center, San Diego

92120

Kaiser Permanente Medical Center, San Diego

92357

VA Loma Linda Healthcare, Loma Linda

94520

John Muir Medical Center - Concord Campus, Concord

95819

Sutter Medical Group - Cardiology, Sacramento

98122

Swedish Medical Center, Seattle

98195

University of Washington, Seattle

98405

Cascade Vascular Associates, P.S., Tacoma

94143-0222

University of California San Francisco - Division of Vascular and Endovascular Surgery, San Francisco

06520

Yale School of Medicine, New Haven

02115

Brigham and Women's Hospital, Boston

02118

Boston Medical Center, Boston

01655

UMASS Memorial Health Care, Worcester

03756

Dartmouth-Hitchcock Medical Center, Lebanon

07052

Vascular Access Center of West Orange, West Orange

All Listed Sponsors
lead

Vericel Corporation

INDUSTRY

NCT01483898 - An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI) | Biotech Hunter | Biotech Hunter