Using stem cells to treat heart attacks

Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention-Phase I Clinical Trial to Assess the Safety.

This study is testing if giving stem cells directly into the heart can help people who have just had a heart attack feel better and recover more effectively.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Taiwan Bio Therapeutics Inc. (industry)
• Locations: 1 site (Kaohsiung City)
• Trial ID: NCT05724576 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and potential benefits of administering allogenic bone marrow-derived mesenchymal stem cells (OmniMSC-AMI) directly into the coronary arteries of patients who have experienced an ST-segment elevation myocardial infarction (STEMI) immediately after primary percutaneous coronary intervention (PCI). The goal is to determine if this treatment can improve left ventricular ejection fraction (LVEF) during follow-up. The study aims to address the significant myocardial damage that occurs after an AMI, which is a leading cause of mortality in cardiovascular disease. By leveraging the regenerative properties of mesenchymal stem cells, the research seeks to protect the heart muscle from further injury and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients aged 20 to 80 who have experienced a STEMI and are treated within 6 hours of symptom onset.

Not a fit: Patients with a history of malignancy, severe comorbidities, or those who are outside the age range of 20 to 80 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart function and survival rates in patients recovering from heart attacks.

How similar studies have performed: While the use of mesenchymal stem cells in cardiac applications is promising, this specific approach is novel and has not been extensively tested in similar contexts.

Eligibility criteria

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.

Where this trial is running

Kaohsiung City

• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Hon-Kan Yip, MD — Chang Gung Memorial Hospital
• Study coordinator: Timothy Huang, PhD

Conditions: Safety Issues, MSC, AMI, PCI