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Tracking Information | |||||
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First Received Date † | November 14, 2006 | ||||
Last Updated Date | November 15, 2006 | ||||
Start Date † | June 2004 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00400959 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | CD133+ Autologous Cells After Myocardial Infarction | ||||
Official Title † | Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction | ||||
Brief Summary | 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:
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Detailed Description | |||||
Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Acute Myocardial Infarction | ||||
Intervention † | Procedure: cd133+cell intracoronary administration | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 15 | ||||
Completion Date | October 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Italy | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00400959 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Fondazione Ospedale Maggiore Policlinico Milano | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Fondazione Ospedale Maggiore Policlinico Milano | ||||
Verification Date | November 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |