Stem Cell in Acute Myocardial Infarction

PT. Prodia Stem Cell Indonesia4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Mesenchymal Stem CellsBIOLOGICAL

The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

PT Prodia StemCell Indonesia

Jakarta, Indonesia