A Study of Allogeneic Low Oxygen Mesenchymal Bone Marrow Cells in Subjects With Myocardial Infarction

NCT02672267 | Completed Phase 3 DMC

• 1 other identifier: CARDIO 1/2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).

Conditions

Myocardial Infarction

Keywords

AMI, hBMMSCs, stem cells,

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (5)

• The change from baseline on physical exam conducted at 1, 3 and 6 months post-administration

  6 months

• LV end diastolic volume

  3 months

• LV end systolic volume

  3 months

• Infarct size measured by MRI, with contrast

  3 months

• Global Left Ventricular Ejection Fraction

  3 months

Study Arms (2)

Stem Cells

EXPERIMENTAL

Experimental: Stem Cells ALLOGENEIC LOW OXYGEN MESENCHYMAL BONE MARROW CELLS Intervention: Biological: Stem cells

Biological: Stem cells

Placebo

PLACEBO COMPARATOR

Lactated Ringer's Solution

Other: Placebo

Interventions

Stem cells BIOLOGICAL

human Allogeneic Low Oxygen mesenchymal stem cells; Ischemia tolerant

Also known as: Allogeneic Low Oxygen mesenchymal stem cells

Stem Cells

Placebo OTHER

Lactated Ringer's Solution

Placebo

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 Acute Myocardial Infarction (STEMI, non STEMI) within 7 days of study enrollment. Myocardial infarction is defined as ECG, Lab and CMR evidences.
• 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
• 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).
• Porphyria.

Sponsors & Collaborators

• Altaco XXI, LLP: lead
• Duke University: collaborator

Study Sites (1)

National Research Medical Center

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Saule Abseitova, MD, Prof.

  National Research Medical Center

  PRINCIPAL INVESTIGATOR

• Daniyar Jumaniyazov, MD, PhD

  Altaco XXI, LLP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-04

Locations

KA (1)