A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With ST Segment Elevation Myocardial Infarction (STEMI)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stemedica Cell Technologies, Inc.
First received: January 14, 2013
Last updated: December 2, 2014
Last verified: December 2014
The purpose of this study is to assess the safety and tolerability of human allogeneic mesenchymal bone marrow cells (aMBMC) administered intravenously to subjects with ST Segment Elevation Myocardial Infarction (STEMI).
ST Segment Elevation Myocardial Infarction (STEMI)
Allogeneic Mesenchymal Bone Marrow Cells
Biological: Stem cells
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A PHASE IIa, DOUBLE-BLINDED, MULTI-CENTER, RANDOMIZED STUDY TO ASSESS THE SAFETY,TOLERABILITY, AND PRELIMINARY EFFICACY OF A SINGLE INTRAVENOUS DOSE OF ALLOGENEIC MESENCHYMAL BONE MARROW CELLS TO SUBJECTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)
Primary Outcome Measures:
- The safety and tolerability of aMBMC intravenous administration during the twelve month study period as determined by major adverse events MACE endpoint. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The change from baseline on physical exam conducted at day 14 and at 1, 3, 6 and 12 months post-administration, as available: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • LV end diastolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • LV end systolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • Infarct size measured by MRI, with and without contrast (only for patients eligible for MRI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • Global Left Ventricular Ejection Fraction (measured by echocardiography) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • SF-36 Health Assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- • Incidence of Ventricular Arrhythmias requiring intervention at 1 and 3 months post-administration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2016 (Final data collection date for primary outcome measure)
Experimental: Stem Cells
ALLOGENEIC MESENCHYMAL BONE MARROW CELLS
Biological: Stem cells
Allogeneic mesenchymal stem cells
Placebo Comparator: Control
Lactated Ringer's Solution
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males and females 18-85 years of age.
- First ST Segment Elevation Myocardial Infarction (STEMI) of ischemic etiology affecting the left ventricle within 7 days of study enrollment. Myocardial infarction is defined as ECG evidence of clinically significant ST-segment elevation (>1mm [0.1 mV] in at least 2 contiguous precordial leads or in at least 2 adjacent limb leads).
Subject had successful revascularization within 12 hours of symptoms as evidenced by residual stenosis < 30% and TIMI antegrade flow II or III in the culprit vessel. Revascularization may include one of the following:
- PCI angioplasty/stenting placement
- Thrombolytic therapy
- LVEF ≤45% as determined by 16-lead quantitative 2D echocardiography more than 24 hours after revascularization.
- Life expectancy greater than 12 months.
- Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.
Reasonable expectation that subject will receive standard post myocardial infarction care, unless contraindicated, including medications:
• Anticoagulation (e.g. aspirin, clopidogrel, ticlopidine, prasugrel, etc.), beta-blockers, ace inhibitors, and statin agents, as tolerated.
- Attend all scheduled safety follow-up visits.
Hemodynamic instability as demonstrated by any of the following:
- Requirement of intra-aortic balloon pump of left ventricular assist device.
- Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥60 mmHg.
- History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
- Clinically-significant hematologic, hepatic, or renal impairment within 24 hours of study procedure as determined by screening clinical laboratory tests. Severe chronic anemia or hematocrit ≤24%. Liver function tests (total bilirubin at 3 times upper limit of normal, or creatinine level ≥3mg/dL).
- Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject.
- Participation in another study with an investigational drug or device within 3 months prior to stem cell administration.
- History within the past year of drug or alcohol abuse.
- Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study.
- Inability to comply with the conditions of the protocol.
- Presence of a transplanted tissue or organ or left ventricular assist device (LVAD) (or the expectation of the same within the next 12 months).
- Planned Automatic Implantable Cardiac Defibrillator (AICD) or CRT within the next 12 months.
- Need for chronic intermittent inotropic therapy.
- Active myocarditis or early postpartum cardiomyopathy (within the first twelve months of delivery).
- Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study stem cell administration.
- Allergy to sodium citrate or any "caine" type of local anesthetic.
- Subject scheduled for hospice care.
- Clinically relevant abnormal findings in the clinical history, physical examination, ECG (e.g. life threatening arrhythmias, including QTc interval of ≥550 ms) or laboratory tests at the screening assessment that would interfere with the objectives of the study or that would, in the Investigator's opinion, preclude safe completion of the study.
- Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as subjects undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.
- Any other medical, social, or geographical factor that would make it unlikely that the subject could comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of noncompliance).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01770613
|Mercy Gilbert and Chandler Medical Center
|Gilbert, Arizona, United States, 85224 |
|Emory University Hospital
|Atlanta, Georgia, United States, 30033 |
|Sanford Health Cardiovascular Institute
|Sioux Falls, South Dakota, United States, 57105 |
Stemedica Cell Technologies, Inc.
||Nabil Dib, MD, MSc, FACC
||Mercy Gilbert Medical Center, Dignity Health
No publications provided
||Stemedica Cell Technologies, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 14, 2013
||December 2, 2014
||United States: Food and Drug Administration
Keywords provided by Stemedica Cell Technologies, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2015