ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
A 12-Month Follow-Up Study to Protocol 24779 (A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia [ACT34-CMI])
1 other identifier
observational
150
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedNovember 28, 2018
November 1, 2018
2.5 years
October 16, 2007
November 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
Test 1 (n=50)
1 x 10\^5 (+/-10%) CD34+ cells/kg of body weight
Test 2 (n=50)
5 x 10\^5 (+/-10%) CD34+ cells/kg of body weight
Placebo (n=50)
Saline plus 5% autologous plasma
Eligibility Criteria
Subjects who have received treatment with Auto-CD34+ cells (1 x 10\^5 (+/-10%) CD34+ cells/kg or 5 x 10\^5 (+/-10%) CD34+ cells/kg)or with placebo (saline plus 5% autologous plasma) and who have completed the final study visit (Month 12) of the core therapeutic study 24779
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Cardiology, PC
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Scripps Green Hospital / Scripps Clinical Hospital
La Jolla, California, 92037, United States
Stanford University Hospital and Clinics
Stanford, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Florida Health Science Center
Jacksonville, Florida, United States
Cardiovascular Institute Florida Hospital
Orlando, Florida, United States
The Medical Group of St. Joseph´s
Atlanta, Georgia, United States
Northwestern University Medical School
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Caritas St. Elizabeth´s Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Cornell University
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
Heart Care Associates, LLC
Milwaukee, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Caladrius Study Director
Lisata Therapeutics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
October 1, 2007
Primary Completion
April 1, 2010
Study Completion
June 1, 2010
Last Updated
November 28, 2018
Record last verified: 2018-11