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| Tracking Information | |||||
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| First Received Date ICMJE | March 6, 2006 | ||||
| Last Updated Date | October 28, 2009 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Frequency of angina episodes [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Frequency of angina episodes | ||||
| Change History | Complete list of historical versions of study NCT00300053 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | ACT34-CMI -- Adult Autologous CD34+ Stem Cells | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of adult stem cells in patients with refractory chronic myocardial ischemia. |
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| Detailed Description | This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor for the reduction of angina episodes in patients with refractory chronic myocardial ischemia. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Myocardial Ischemia | ||||
| Intervention ICMJE | Device: stem cell injection | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* 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 ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00300053 | ||||
| Responsible Party | Peter Adams, Baxter Healthcare Corporation | ||||
| Study ID Numbers ICMJE | 24779 | ||||
| Study Sponsor ICMJE | Baxter Healthcare Corporation | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Baxter Healthcare Corporation | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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