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Completed

NCT Number: NCT04050163

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

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)

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chung Shan Medical University Hospital, Taichung, Taichung City, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MiSaver®

Biological

Intravenous administration of MiSaver® Stem Cell via peripheral vein access.

Other names: stem cells

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events

    Time frame: 12 months

    Number of Adverse Events

Secondary outcomes

  1. 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).

  2. End diastolic volume

    Time frame: 12 months

    Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc)

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Honya Medical Inc

Industry

Collaborators

  • Chung Shan Medical University

Registry information

Official study title

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

Acronym: MiSaver®

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2019
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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