MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction) (MiSaver®)

March 27, 2024 updated by: Honya Medical Inc

Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.

The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 74147
        • HONYA Medical Inc
    • Taichung City
      • Taichung, Taichung City, Taiwan, 402
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 20~80
  • Acute Myocardial Infarction 1 to 10 days
  • Cardiac enzyme CK-MB or Troponin > 2X of high-end normal value
  • ST-elevation on EKG (STEMI)
  • Presence of regional wall motion abnormality
  • Left ventricular ejection fraction (LVEF) of ≤40%
  • Hemodynamically stable past 24 hour
  • Participants with adequate pulmonary function
  • Peripheral artery oxygen saturation ≥97%
  • Karnofsky performance status scores of ≥60.

Exclusion Criteria:

  • Age <20 or >80
  • Pregnant or breast feeding
  • Positive adventitious infections (such as HIV, hepatitis )
  • Revascularization via coronary artery bypass surgery is required
  • Coronary revascularization procedures is anticipated during the 6-month study period
  • Severe aortic or mitral valve narrowing
  • Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
  • Short of breath unable to receive PCI examination or treatment
  • Malignant tumor
  • Hematopoietic dysplasia
  • Severe organ disease
  • With less than 1 year of life expectancy
  • Chronic kidney disease with CCr<20ml/min
  • Kidney disease on renal dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose
Cells dosage, 0.5x10^7 cells/kg body weight
Biological: MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other Names:
  • stem cells
Experimental: Intermediate Dose (aka Effective or High)
Cells dosage, 1.6x10^7 cells/kg body weight
Biological: MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other Names:
  • stem cells
Experimental: Toxic Dose
Cells dosage, 5.0 x10^7 cells/kg body weight
Biological: MiSaver®
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other Names:
  • stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse Events
Time Frame: 12 months
Number of Adverse Events
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricle stroke volume
Time Frame: 12 months
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
12 months
Left ventricular ejection fraction (LVEF)
Time Frame: 12 months
Calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
12 months
End diastolic volume
Time Frame: 12 months
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc)
12 months
Participants Functional Activity by NYHA Classification
Time Frame: 12 months
The New York Heart Association (NYHA) Functional Classification is a useful tool for classifying the extent of functional limitations in patients with heart conditions. The system categorizes patients into one of four categories based on the level of limitation they experience during physical activity, with symptoms ranging from mild shortness of breath or angina to more severe breathing difficulties. The NYHA classification focuses specifically on limitations related to physical activity and provides a straightforward approach to assessing a patient's condition. By using this system, healthcare providers can quickly and easily determine the level of functional limitation in their patients and tailor treatment plans accordingly.
12 months
Participants Functional Activity by CCS Classification
Time Frame: 12 months
The Canadian Cardiovascular Society grading of angina pectoris, also known as the CCS Functional Classification, is a widely used clinical tool that classifies the severity of exertional angina. It allows doctors to assess the degree of angina severity in patients, and subsequently develop a tailored treatment plan. Although there are no definitive therapy guidelines specific to each class, healthcare providers can use the CCS grading system as a framework to guide treatment planning based on the severity of angina and other individual factors such as age and the risk of major cardiac complications. By utilizing the CCS grading system, healthcare providers can ensure that patients receive personalized treatment that addresses their unique needs and circumstances.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Honya Medical Inc

Collaborators

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Actual)

May 4, 2023

Study Completion (Actual)

May 4, 2023

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • csho19052112001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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