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

NCT05724576 | Recruiting Phase 1 DMC

• 1 other identifier: 202002401A0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety Issues

Keywords

MSC; AMI; PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart function after AMI

  1-7 days

• Heart function after treatment

  6 months

Study Arms (2)

Low dose allogeneic mesenchymal stromal cells

EXPERIMENTAL

Intracoronary administration 1.5 x 10\^7 OmniMSC-AMI in first AMI patients who just underwent primary PCI

Biological: OmniMSC-AMI

High dose allogeneic mesenchymal stromal cells

EXPERIMENTAL

Intracoronary administration 3.0 x 10\^7 OmniMSC-AMI in first AMI who just underwent primary PCI

Biological: OmniMSC-AMI

Interventions

OmniMSC-AMI BIOLOGICAL

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).

High dose allogeneic mesenchymal stromal cells; Low dose allogeneic mesenchymal stromal cells

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patents, with age ≤20 or ≤80 years old.
• Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction):
• Chest pain onset.
• lead EKG:V1-V6 ≥ consecutive lead ST-segment elevation ≥1 mm.
• TnT-I elevation.
• Into emergency ≤ 6h upon AMI presentation.
• Patients are willing to receive the treatment and sign the informed consent.

You may not qualify if:

• Age \< 20 or \>80 years old.
• History of
• Malignancy.
• Sepsis (abnormal WBC count elevation).
• Hematologic disorder.
• AIDS.
• Advanced liver cirrhosis.
• 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.

Sponsors & Collaborators

• Taiwan Bio Therapeutics Inc.: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Study Officials

• Hon-Kan Yip, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Huang, PhD

CONTACT

02-26956382; timothy.huang@twbio-thera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 10 anterior wall STEMI patients without cardiogenic shock will be enrolled into group 1 (i.e., will receive 1.5 x 107 OmniMSC-AMI, n=5) and then group 2 (3.0 x 107 OmniMSC-AMI, n=5).

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 13, 2023
• Study Start: June 26, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

TW (1)