Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients
Sponsored by Taiwan Bio Therapeutics Inc.
About this trial
Last updated 8 months ago
Study ID
202002401A0
Status
Recruiting
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
20 to 80 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 2 years ago
What is this trial about?
This study will test the hypothesis intracoronary administration of OmniMSC-AMI
(allogenic bone marrow-derived mesenchymal stem cells) just after finishing the primary
percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction
(STEMI) patients without cardiogenic shock is safe and may provide benefit on improving
left ventricular ejection fraction (LVEF) during clinical follow-up.
What are the participation requirements?
Inclusion Criteria
- Patents, with age ≤20 or ≤80 years old.
- Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction):
1. Chest pain onset.
2. 12-lead EKG:V1-V6 ≥ consecutive lead ST-segment elevation ≥1 mm.
3. TnT-I elevation.
- Into emergency ≤ 6h upon AMI presentation.
- Patients are willing to receive the treatment and sign the informed consent.
Exclusion Criteria
- Age < 20 or >80 years old.
- History of
1. Malignancy.
2. Sepsis (abnormal WBC count elevation).
3. Hematologic disorder.
4. AIDS.
5. Advanced liver cirrhosis.
6. CKD stage 5 with Ccr <15 ml/min.
- AMI occurrence > 6 hours
- Non-first AMI.
- Pregnancy or breastfeeding.
- Prison.
- Cancer treatment within 2 years.
- Expected lifespan < 6 months.
- Non-suitable candidate evaluated by PI.
- Participating in other clinical trials.
Locations
Location
Status
Recruiting