Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
This study has been completed.
Sponsor:
Stempeutics Research Pvt Ltd
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT00883727
First received: April 17, 2009
Last updated: March 4, 2013
Last verified: March 2013
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | April 17, 2009 | ||||||||||||||||
| Last Updated Date | March 4, 2013 | ||||||||||||||||
| Start Date ICMJE | April 2009 | ||||||||||||||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
AE and ECG parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00883727 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Regional myocardial perfusion and infarct size [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI | ||||||||||||||||
| Official Title ICMJE | A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi) | ||||||||||||||||
| Brief Summary | This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Myocardial Infarction | ||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||
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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 | Completed | ||||||||||||||||
| Enrollment ICMJE | 20 | ||||||||||||||||
| Completion Date | August 2012 | ||||||||||||||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 20 Years to 70 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | India | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00883727 | ||||||||||||||||
| Other Study ID Numbers ICMJE | SRPL/AMI/07-08/001 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | Stempeutics Research Pvt Ltd | ||||||||||||||||
| Study Sponsor ICMJE | Stempeutics Research Pvt Ltd | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Stempeutics Research Pvt Ltd | ||||||||||||||||
| Verification Date | March 2013 | ||||||||||||||||
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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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