A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With ST Segment Elevation Myocardial Infarction (STEMI)

NCT01770613 | Withdrawn Phase 2 DMC

• 1 other identifier: STEM 103-M-STEMI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

ST Segment Elevation Myocardial Infarction (STEMI); Allogeneic Mesenchymal Bone Marrow Cells

Keywords

Adult; Allogeneic; Stem; Cells; Myocardial; Infarction

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of aMBMC intravenous administration during the twelve month study period as determined by major adverse events MACE endpoint.

  12 months

Secondary Outcomes (7)

• The change from baseline on physical exam conducted at day 14 and at 1, 3, 6 and 12 months post-administration, as available:

  12 months

• • LV end diastolic volume

  12 months

• • LV end systolic volume

  12 months

• • Infarct size measured by MRI, with and without contrast (only for patients eligible for MRI)

  12 months

• • Global Left Ventricular Ejection Fraction (measured by echocardiography)

  12 months

Study Arms (2)

Stem Cells

EXPERIMENTAL

ALLOGENEIC MESENCHYMAL BONE MARROW CELLS

Biological: Stem cells

Control

PLACEBO COMPARATOR

Lactated Ringer's Solution

Biological: Stem cells

Interventions

Stem cells BIOLOGICAL

Allogeneic mesenchymal stem cells

Control; Stem Cells

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stemedica Cell Technologies, Inc.: lead
• CardioCell LLC: collaborator

Study Sites (2)

Mercy Gilbert and Chandler Medical Center

Gilbert, Arizona, 85224, United States

Location

Emory University Hospital

Atlanta, Georgia, 30033, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nabil Dib, MD, MSc, FACC

  Mercy Gilbert Medical Center, Dignity Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 18, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (2)