Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

October 31, 2016

Conditions
Myocardial Ischemia
Interventions
DEVICE

ADRCs processed by the Celution System

Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.

DEVICE

Placebo Comparator: Lactated Ringer's and Subject's Blood

Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.

Trial Locations (8)

27705

Duke University Hospital, Durham

32610

University of Florida, Gainesville

33613

Florida Hospital-Pepin Heart Institute, Tampa

35211

Cardiology, P.C., Birmingham

55407

Minneapolis Heart Institute Foundation, Minneapolis

77030

Texas Heart Institute, Houston

84132

University of Utah Health Care, Salt Lake City

92037

Scripps Clinic - Torrey Pines, Scripps Green Hospital, La Jolla

Sponsors
All Listed Sponsors
lead

Cytori Therapeutics

INDUSTRY