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

Primary Purpose

Safety Issues

Status
Not yet recruiting
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
OmniMSC-AMI
Sponsored by
Taiwan Bio Therapeutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety Issues focused on measuring MSC, AMI, PCI

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patents, with age ≤20 or ≤80 years old. Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction): Chest pain onset. 12-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. Exclusion Criteria: 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. Participating in other clinical trials.

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose allogeneic mesenchymal stromal cells

High dose allogeneic mesenchymal stromal cells

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heart function after AMI
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Heart function after treatment
Cardiac MRI and 2-D/3-D echo LVEF results after administration

Full Information

First Posted
January 31, 2023
Last Updated
February 9, 2023
Sponsor
Taiwan Bio Therapeutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05724576
Brief Title
Intracoronary Administration of OmniMSC-AMI for Acute ST-segment Elevation Myocardial Infarction Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Bio Therapeutics Co., Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues
Keywords
MSC, AMI, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose allogeneic mesenchymal stromal cells
Arm Type
Experimental
Arm Description
Intracoronary administration 1.5 x 10^7 OmniMSC-AMI in first AMI patients who just underwent primary PCI
Arm Title
High dose allogeneic mesenchymal stromal cells
Arm Type
Experimental
Arm Description
Intracoronary administration 3.0 x 10^7 OmniMSC-AMI in first AMI who just underwent primary PCI
Intervention Type
Biological
Intervention Name(s)
OmniMSC-AMI
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of adverse events occurring in given time frame shall be reported to evaluate overall safety.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Heart function after AMI
Description
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Time Frame
1-7 days
Title
Heart function after treatment
Description
Cardiac MRI and 2-D/3-D echo LVEF results after administration
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patents, with age ≤20 or ≤80 years old. Fit to the definition of ST-elevation myocardial infarction (anterior myocardial infarction): Chest pain onset. 12-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. Exclusion Criteria: 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. Participating in other clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Huang, PhD
Phone
02-26956382
Ext
512
Email
timothy.huang@twbio-thera.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hon-Kan Yip, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung city
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hon-Kan Yip, MD
Email
han.gung@msa.hinet.net

12. IPD Sharing Statement

Learn more about this trial

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

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