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 |
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.
(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
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University of Cincinnati Medical Center Opening in 1823 as the country
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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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
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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