Clinical trial NCT04340609: Stem Cell in Acute Myocardial Infarction
Official title: Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Allogeneic Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells
Intravenous Mesenchymal Stem Cells
Intracoronary Mesenechymal Stem Cells
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac events (MACE) endpoints of mortality
timeFrame: 2 weeks after stem cell
measure: Major adverse cardiac events (MACE) endpoints of mortality
timeFrame: 3 months after stem cell
measure: Major adverse cardiac events (MACE) endpoints of mortality
timeFrame: 6 months after stem cell
measure: Major adverse cardiac events (MACE) endpoints of mortality
timeFrame: 12 months after stem cell
measure: Re-infarction
timeFrame: 2 weeks after stem cell
measure: Re-infarction
timeFrame: 3 months after stem cell
measure: Re-infarction
timeFrame: 6 months after stem cell
measure: Re-infarction
timeFrame: 12 months after stem cell
measure: Target vessel revascularization (TVR)
timeFrame: 2 weeks after stem cell
measure: Target vessel revascularization (TVR)
timeFrame: 3 months after stem cell
measure: Target vessel revascularization (TVR)
timeFrame: 6 months after stem cell
measure: Target vessel revascularization (TVR)
timeFrame: 12 months after stem cell
measure: Heart failure hospitalization
timeFrame: 2 weeks after stem cell
measure: Heart failure hospitalization
timeFrame: 3 months after stem cell
measure: Heart failure hospitalization
timeFrame: 6 months after stem cell
measure: Heart failure hospitalization
timeFrame: 12 months after stem cell
Secondary outcomes:
measure: Cardiac MRI
timeFrame: 6 months after stem cell
measure: Cardiac MRI
timeFrame: 12 months after stem cell
measure: Echocardiography
timeFrame: 6 months after stem cell
measure: Echocardiography
timeFrame: 12 months after stem cell
measure: Electrocardiography (ECG)
timeFrame: 3 months after stem cell
measure: Electrocardiography (ECG)
timeFrame: 6 months after stem cell
measure: Electrocardiography (ECG)
timeFrame: 12 months after stem cell
measure: Wellness Parameter
timeFrame: 6 months after stem cell
measure: Laboratory Assessment
timeFrame: 12 months after stem cell
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Prodia StemCell Indonesia
Study officials:
References: