Stem Cell in Acute Myocardial Infarction (AMI)

PT. Prodia Stem Cell Indonesia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Myocardial Infarction

Treatments: Biological: Mesenchymal Stem Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04340609

CT/AMI/01/2019

Details and patient eligibility

About

The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.

Enrollment: 4 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
• Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of < 45% by echocardiography.
• 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,
• Willingness to attend all scheduled safety follow-up visits
• Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF <45).

Exclusion criteria

• 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,
• Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb < 10 g/dL, WBC < 4 or > 11x109/L, or platelets < 100x109/L), kidney failure (creatinine level > 2.5 mg/dL, or creatinine clearance < 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
• Prosthetic valves,
• Hypertrophic or restrictive cardiomyopathy,
• Women of child-bearing potential,
• Inability to comply with the protocol,
• Currently using implantable electronic defibrillator or pacemaker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Intravenous Group

Experimental group

Description:

Dosage of intravenous route is 2 million MSCs/kg for each subject.

Treatment:

Biological: Mesenchymal Stem Cells

Intracoronary Group

Experimental group

Description:

Dosage of intracoronary route is ±50 million MSCs for each subject.

Treatment:

Biological: Mesenchymal Stem Cells

Control Group

No Intervention group

Description:

Standard treatment of acute myocardia infarction