ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 81
Updated:11/30/2018
Start Date:October 2007
End Date:June 2010

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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])

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.


Inclusion Criteria:

- 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
We found this trial at
23
sites
5669 Peachtree Dunwoody Road
Atlanta, Georgia 30342
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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201 East Huron Street
Chicago, Illinois 60611
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Birmingham, Alabama 35211
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736 Cambridge Street
Boston, Massachusetts 02135
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Cincinnati, Ohio 45219
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Jacksonville, Florida 32209
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La Jolla, CA
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Madison, Wisconsin 53792
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5555 North Port Washington Road
Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55407
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New York, New York 10021
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New York, New York 10032
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1111 South Semoran Boulevard
Orlando, Florida 32807
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Phoenix, Arizona
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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