ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
- Conditions
- Myocardial Ischemia
- Registration Number
- NCT00545610
- Lead Sponsor
- Lisata Therapeutics, Inc.
- Brief Summary
The purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in subjects with chronic refractory myocardial ischemia. No treatments will be administered during this study. However, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779
- Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Long-term safety of intramyocardial injections of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia over a 12-month follow-up period. 12 months
- Secondary Outcome Measures
Name Time Method Long-term efficacy of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia and the effects of this treatment on quality of life (QoL) over a 12-month follow-up period 12 months
Trial Locations
- Locations (23)
Caritas St. Elizabeth´s Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The Medical Group of St. Joseph´s
🇺🇸Atlanta, Georgia, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Scripps Green Hospital / Scripps Clinical Hospital
🇺🇸La Jolla, California, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
Stanford University Hospital and Clinics
🇺🇸Stanford, California, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Cardiology, PC
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Cardiovascular Institute Florida Hospital
🇺🇸Orlando, Florida, United States
Heart Care Associates, LLC
🇺🇸Milwaukee, Wisconsin, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Cornell University
🇺🇸New York, New York, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States