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Sponsored by: |
Fondazione Ospedale Maggiore Policlinico Milano |
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Information provided by: | Fondazione Ospedale Maggiore Policlinico Milano |
ClinicalTrials.gov Identifier: | NCT00400959 |
TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.
TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).
OBJECTIVES Primary:
To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.
Secondary:
Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Procedure: cd133+cell intracoronary administration |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction |
Estimated Enrollment: | 15 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | October 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Cell Factory, department of regenerative medicine, Policlinic of Milan | |
Milan, Italy |
Principal Investigator: | Rosaria Giordano, MD | Cell Factory Department of Regenerative Medicine Policlinic Milan |
Study ID Numbers: | CFT92002 |
Study First Received: | November 14, 2006 |
Last Updated: | November 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00400959 History of Changes |
Health Authority: | Italy: National Institute of Health |
cell therapy acute myocardial infarction |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |