321
Participants
Start Date
April 30, 2006
Primary Completion Date
March 31, 2008
Study Completion Date
March 31, 2009
CLBS14 (low-dose)
Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 1 x 10\^5 (=100000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.
CLBS14 (high-dose)
Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 5 x 10\^5 (=500000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.
placebo injection
Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Placebo will be delivered in 10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma into the target areas of myocardial ischemia.
New York Presbyterian Hospital - Columbia University Medical Center, New York
New York Presbyterian Hospital - Weill Cornell Medical College of Cornell University, New York
University of Pittsburgh Medical Center, Pittsburgh
Washington Hospital Center, Washington D.C.
Saint Joseph's Research Institute, Atlanta
University of Florida Health Science Center, Jacksonville
University of Florida Health Science Center, Gainesville
Central Florida Cardiology Group, Orlando
Holy Cross Hospital, Fort Lauderdale
Cardiology PC, Birmingham
University Hospitals Case Medical Center, Cleveland
The Lindner Clinical Trial Center, Cincinnati
University of Cincinnati Medical Center, Cincinnati
University of Iowa Hospitals & Clinic, Iowa City
Comprehensive Cardiovascular Care Group, Milwaukee
University of Wisconsin Medical School, Madison
Abbott Northwestern Hospital, Minneapolis
Northwestern University Medical Center, Bluhm Cardiovascluar Institute, Chicago
Rush University Medical Center, Chicago
Arizona Heart Institute, Phoenix
Mayo Clinic Hospital, Phoenix
Scripps Memorial Hospital, La Jolla
Stanford University Hospital and Clinics, Stanford
Swedish Heart & Vascular - Swedish Medical Center, Seattle
Massachusetts General Hospital, Boston
Caritas Saint Elizabeth's Medical Center, Boston
Lead Sponsor
Lisata Therapeutics, Inc.
INDUSTRY