Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)
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ClinicalTrials.gov Identifier: NCT01458405 |
Recruitment Status :
Terminated
(On February 28, 2019, Capricor ceased ongoing follow-up activities and terminated the ALLSTAR trial to focus resourcing on its active CAP-1002 program, HOPE-2.)
First Posted : October 24, 2011
Last Update Posted : April 9, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | October 20, 2011 | |||
First Posted Date ICMJE | October 24, 2011 | |||
Last Update Posted Date | April 9, 2019 | |||
Actual Study Start Date ICMJE | November 13, 2012 | |||
Actual Primary Completion Date | July 3, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Infarct size assessed by MRI [ Time Frame: 12 Months ] The primary safety endpoint is the proportion of patients that experience active myocarditis possibly attributable to treatment accompanied by the presence of circulating antibodies specific to the CAP-1002 CDC donor, death due to ventricular tachycardia or ventricular fibrillation, sudden unexpected death, or a major adverse cardiac event (MACE).
The primary efficacy endpoint is relative percentage improvement in infarct size assessed by MRI for the CAP-1002 group compared to the placebo group at 12 months post-infusion.
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Original Primary Outcome Measures ICMJE |
Infarct size assessed by MRI | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration | |||
Official Title ICMJE | Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction | |||
Brief Summary | The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Myocardial Infarction | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
156 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 28, 2019 | |||
Actual Primary Completion Date | July 3, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01458405 | |||
Other Study ID Numbers ICMJE | 1002-01 RC3HL103356-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Capricor Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Capricor Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Capricor Inc. | |||
Verification Date | April 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |