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 Undergoing Primary Percutaneous Coronary Intervention-Phase I Clinical Trial to Assess the Safety.

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.

Study Overview

• Status: Recruiting
• Conditions: Safety Issues
• Intervention / Treatment: Biological: OmniMSC-AMI

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Timothy Huang, PhD; Phone Number: 512 02-26956382; Email: timothy.huang@twbio-thera.com

Study Locations

• Taiwan
  • Kaohsiung city, Taiwan
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Hon-Kan Yip, MD; Email: han.gung@msa.hinet.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose allogeneic mesenchymal stromal cells; Intracoronary administration 1.5 x 10^7 OmniMSC-AMI in first AMI patients who just underwent primary PCI	Biological: OmniMSC-AMI; 10 anterior wall STEMI patients without cardiogenic shock will be enrolled into low dose group 1 (1.5 x 10^7 OmniMSC-AMI, n=5) and then high dose group 2 (3.0 x 10^7 OmniMSC-AMI, n=5).
Experimental: High dose allogeneic mesenchymal stromal cells; Intracoronary administration 3.0 x 10^7 OmniMSC-AMI in first AMI who just underwent primary PCI	Biological: OmniMSC-AMI; 10 anterior wall STEMI patients without cardiogenic shock will be enrolled into low dose group 1 (1.5 x 10^7 OmniMSC-AMI, n=5) and then high dose group 2 (3.0 x 10^7 OmniMSC-AMI, n=5).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Number of adverse events occurring in given time frame shall be reported to evaluate overall safety.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart function after AMI	Cardiac MRI and 2-D/3-D echo LVEF results after administration	1-7 days
Heart function after treatment	Cardiac MRI and 2-D/3-D echo LVEF results after administration	6 months

Collaborators and Investigators

• Sponsor: Taiwan Bio Therapeutics Co., Ltd.
• Investigators: Principal Investigator: Hon-Kan Yip, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PCI; AMI; MSC
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 202002401A0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No