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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2016
• Main ID: NCT02672267
• Date of registration: 01/02/2016
• Prospective Registration: No
• Primary sponsor: Altaco XXI, LLP
• Public title: A Study of Allogeneic Low Oxygen Mesenchymal Bone Marrow Cells in Subjects With Myocardial Infarction
• Scientific title: A Phase III, Double-blinded, Single Center, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Single Intravenous Dose of Allogeneic Ischemia Tolerant Human Mesenchymal Bone Marrow Cells to Subjects With Acute Myocardial Infarction
• Date of first enrolment: July 2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02672267
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Kazakhstan

Contacts

• Name: Daniyar Jumaniyazov, MD, PhD
• Affiliation: Altaco XXI, LLP

• Name: Saule Abseitova, MD, Prof.
• Affiliation: National Research Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females 18-85 years of age.

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

3. 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

4. Life expectancy greater than 12 months.

5. 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.

6. 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.

7. Attend all scheduled safety follow-up visits.

Exclusion Criteria:

1. 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.

2. History of cancer within the past 5 years, with the exception of localized basal or
squamous cell carcinoma.

3. 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).

4. 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.

5. Participation in another study with an investigational drug or device within 3 months
prior to stem cell administration.

6. History within the past year of drug or alcohol abuse.

7. 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.

8. Inability to comply with the conditions of the protocol.

9. Presence of a transplanted tissue or organ or left ventricular assist device (LVAD)
(or the expectation of the same within the next 12 months).

10. Planned Automatic Implantable Cardiac Defibrillator (AICD) or CRT within the next 12
months.

11. Need for chronic intermittent inotropic therapy.

12. Active myocarditis or early postpartum cardiomyopathy (within the first twelve months
of delivery).

13. Porphyria.

14. Allergy to sodium citrate or any "caine" type of local anesthetic.

15. Subject scheduled for hospice care.

16. 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.

17. 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.

18. 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).



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Intervention(s)

Biological: Stem cells

Other: Placebo

Primary Outcome(s)

The safety and tolerability of aMBMC intravenous administration during the six month study period as determined by major adverse events MACE endpoint [Time Frame: 6 months]

Secondary Outcome(s)

Infarct size measured by MRI, with contrast [Time Frame: 3 months]

Global Left Ventricular Ejection Fraction [Time Frame: 3 months]

LV end systolic volume [Time Frame: 3 months]

The change from baseline on physical exam conducted at 1, 3 and 6 months post-administration [Time Frame: 6 months]

LV end diastolic volume [Time Frame: 3 months]

Secondary ID(s)

CARDIO 1/2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke University