Image

Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients

Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients

Recruiting
20-80 years
All
Phase 1

Powered by AI

Overview

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.

Description

Despite state-of-the-art advances in the treatment of acute myocardial infarction (AMI), including early and prompt reperfusion therapy and advanced pharmaceutical therapy, AMI remains the leading cause of death of patients hospitalized for cardiovascular disease. Loss of myocardium after AMI, resulting in reducing LVEF and ultimately pump failure, are essential for unfavorable clinical outcomes and mortality, highlighting that to protect the myocardium from AMI-induced damage is the principal rule for treatment of the AMI patients. The pathological findings have clearly identified that loss of myocardium after AMI results from first ischemic necrosis, followed by ischemia-reperfusion injury, vigorous inflammatory reaction, generation of oxidative stress, and finally, upregulation of immune reaction. Thus, a phenomenon of "propagation of myocardium from injury to irrepressible death" at the moment just after AMI always occurs. These are the reasons why a satisfactory therapy for AMI is still difficult, highlighting the timing remains the Achilles' heel for salving the jeopardized myocardium. These raise the consideration of urgently to develop a new effective and safe treatment for patients.

Abundant data have shown mesenchymal stromal cells (MSC) pleiotropic capacities of anti-inflammation, immunomodulation, and tissue regeneration. Experimental studies have further demonstrated that MSC therapy effectively protected the organs from ischemic/ischemia-reperfusion injury. However, the therapeutic impact of stem cells on the clinical setting of AMI is still universally controversial. When investigators further look at the clinical trials, delayed time to apply the stem cells on AMI patients is universally consistent. Investigators have demonstrated that early intracoronary administration (i.e., at the time interval of 90 minutes after AMI induction) of OmniMSC-AMI significantly protected the left ventricular myocardium and improved LVEF in the mini-pig AMI model. The aforementioned issues and the results of our experimental study may support our hypothesis that immediate intracoronary administration of OmniMSC-AMI into the infarcted-related vessel in first AMI patients who just yet underwent primary PCI will be safe and may offer benefits in improving LVEF and outcome.

Eligibility

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.

Study details
    Safety Issues

NCT05724576

Taiwan Bio Therapeutics Co., Ltd.

22 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.