Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction (AMICI)
This study is currently recruiting participants.
Verified April 2013 by Angioblast Systems
Sponsor:
Angioblast Systems
Collaborators:
Mesoblast, Inc.
Mesoblast, Ltd.
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Angioblast Systems
ClinicalTrials.gov Identifier:
NCT01781390
First received: January 14, 2013
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
This is a double blind, randomized, placebo controlled study that will enroll 225 subjects with de novo anterior myocardial infarction due to a lesion of the left anterior descending coronary artery undergoing PCI. Eligible subjects will be enrolled and undergo revascularization of the culprit LAD followed by an intracoronary (IC) delivery of the assigned treatment, infused into the stented culprit artery. The study will determine the safety and feasibility of the IC infusion of investigational MPCs in this patient population.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Other: Mesenchymal Precursor Cells (MPC) Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Double Blind, Randomized, Placebo-controlled Clinical Trial of Intracoronary Infusion of Immunoselected, Bone Marrow-derived Stro3 Mesenchymal Precursor Cells (MPC) in the Treatment of Patients With ST-elevation Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by Angioblast Systems:
Primary Outcome Measures:
- Frequency of the total major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Occurrence of MACCE events including cardiac death, myocardial infarction, target vessel revascularization, stroke, new or worsening congestive heart failure during index hospitalization and cardiac hospitalizations due to congestive heart failure.
| Estimated Enrollment: | 225 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 12.5M MPCs
12.5M Mesenchymal Precursor Cell (MPC) administered via IC infusion
|
Other: Mesenchymal Precursor Cells (MPC) |
|
Experimental: 25M MPCs
25M Mesenchymal Precursor Cell (MPC) administered via IC infusion
|
Other: Mesenchymal Precursor Cells (MPC) |
|
Placebo Comparator: Placebo
Placebo via IC infusion
|
Other: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Clinical symptoms consistent with AMI (pain, etc.) from a minimum of 2 to maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI)
- De Novo anterior Acute Myocardial Infarct (AMI)
- Successful revascularization of the culprit lesion
- Female of child bearing potential willing to use contraception and must have negative pregnancy test upon screening
Key Exclusion Criteria:
- Prior AMI, known cardiomyopathy, or hospital admission for heart failure (HF)
- Significant valvular disease
- Need for staged treatment of coronary artery disease (CAD), or other interventional or surgical procedure to treat heart disease (planned or scheduled)
- Cardiogenic shock or hemodynamic instability within 24 hours of randomization
- Prior PCI to LAD
- Pacemaker, ICD (Implantable Cardioverter Defibrillator), or any other contra-indication for cardiac MRI
- Prior or current participation in any stem cell study or any other investigational trial in the past 30 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781390
Contacts
| Contact: Priya Raina | 212 993 7925 | priya.raina@mesoblast.com |
| Contact: Rebecca Cohen | 212 993 7922 | rebecca.cohen@mesoblast.com |
Locations
| Australia, New South Wales | |
| St. George Hospital | Recruiting |
| Kogarah, New South Wales, Australia, 2217 | |
| Principal Investigator: Ananth Prasan | |
| John Hunter Hospital | Recruiting |
| New Lambton Heights, New South Wales, Australia, 2305 | |
| Principal Investigator: Sukumaran Thambar | |
| Australia, Victoria | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Principal Investigator: Gishel New | |
| The Northern Hospital | Recruiting |
| Epping, Victoria, Australia, 3076 | |
| Principal Investigator: William Van Gaal | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | Not yet recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Principal Investigator: Michelle Ammerer | |
| Australia | |
| Royal Perth Hospital | Recruiting |
| Perth, Australia, 6000 | |
| Principal Investigator: Shetty Sharad | |
| Belgium | |
| UZ Brussel Klinische | Recruiting |
| Brussel, Belgium, 1090 | |
| Principal Investigator: Danny Schoors | |
| Denmark | |
| Rigshospitalet | Recruiting |
| Kobenhavn, Denmark, 2100 | |
| Principal Investigator: Jens Kastrup | |
| New Zealand | |
| Christchurch Hospital | Not yet recruiting |
| Christchurch, New Zealand, 2214 | |
| Principal Investigator: John Elliot | |
| Waikato Hospital | Recruiting |
| Hamilton, New Zealand, 3240 | |
| Principal Investigator: Gerry Devlin | |
Sponsors and Collaborators
Angioblast Systems
Mesoblast, Inc.
Mesoblast, Ltd.
Teva Pharmaceuticals USA
Investigators
| Study Director: | Peter Adams, MD | Mesoblast, Inc. |
| Principal Investigator: | Eric Duckers, MD | UMC Utrecht |
More Information
No publications provided
| Responsible Party: | Angioblast Systems |
| ClinicalTrials.gov Identifier: | NCT01781390 History of Changes |
| Other Study ID Numbers: | ANG.AMI-IC001 |
| Study First Received: | January 14, 2013 |
| Last Updated: | April 29, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee Austria: Agency for Health and Food Safety Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) New Zealand: Medsafe Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Sweden: Medical Products Agency |
Keywords provided by Angioblast Systems:
|
Acute Myocardial Infarction STEMI Heart Attack AMI Stem Cells |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013