An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)

PHASE2CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

February 20, 2013

Primary Completion Date

February 1, 2016

Study Completion Date

March 7, 2018

Conditions
Ischemic Dilated Cardiomyopathy (IDCM)
Interventions
BIOLOGICAL

ixmyelocel-T

12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.

OTHER

Placebo

12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.

Trial Locations (36)

10032

Columbia University Medical Center, New York

15213

UPMC Cardiovascular Institute, Pittsburgh

15240

Veterans Administration Healthcare System, Pittsburgh

19140

Temple University, Philadelphia

30322

Emory University Hospital, Atlanta

30912

Georgia Regents University, Augusta

32117

Cardiology Research Associates, Daytona Beach

32224

Mayo Clinic Florida (Jacksonville), Jacksonville

32610

University of Florida - Division of Cardiology, Gainesville

33136

University of Miami - Miller School of Medicine, Miami

35211

Cardiology, P.C. & Center for Therapeutic Angiogenesis, Birmingham

35294

University of Alabama at Birmingham, Birmingham

38138

Stern Cardiovascular Foundation, Inc., Germantown

44106

University Hospitals - Case Medical Center, Cleveland

45219

The Carl and Edyth Linder Center for Research & Education at The Christ Hospital, Cincinnati

48602

Michigan CardioVascular Institute, Saginaw

53792

University of Wisconsin-Madison Cardiovascular Medicine, Madison

55905

Mayo Clinic, Rochester

60612

Rush University Medical Center, Chicago

70121

Ochsner Clinic Foundation, New Orleans

75226

Soltero Cardiovascular Research Center, Dallas

77030

Methodist DeBakey Heart and Vascular Center, Houston

84132

University of Utah Health Services Center, Salt Lake City

85054

Mayo Clinic Arizona, Phoenix

85297

Mercy Gilbert Medical Center, Gilbert

90048

Cedars-Sinai Heart and Lung Institute, Los Angeles

90095

University of California Los Angeles (UCLA), Los Angeles

92037

Scripps Clinic, La Jolla

UCSD Medical Center, La Jolla

93030

St. John's Regional Medical Center, Oxnard

94305

Stanford University, Stanford

98122

Swedish Medical Center - Cherry Hill Professional Building, Seattle

02114

Massachusetts General Hospital, Division of Cardiology, Boston

07112

Newark Beth Israel Hospital, Newark

T6G 287

University of Alberta Hospital, Edmonton

H1T 1C8

Montreal Heart Institute, Montreal

All Listed Sponsors
lead

Vericel Corporation

INDUSTRY

NCT01670981 - An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM) | Biotech Hunter | Biotech Hunter