Status:
COMPLETED
Stem Cell in Acute Myocardial Infarction
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 intraveno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04340609
Start Date
March 11 2019
End Date
April 8 2022
Last Update
June 14 2022
Active Locations (1)
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1
PT Prodia StemCell Indonesia
Jakarta, Indonesia