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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
MiSaver®
Sponsored by
Honya Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Heart Attack

Eligibility Criteria

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

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

Sites / Locations

  • Chung Shan Medical University Hospital
  • HONYA Medical Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Dose

Intermediate Dose

Toxic Dose

Arm Description

Cells dosage, 1/vial for every 20kg body weight.

Cells dosage, 1/vial for every 10kg body weight.

Cells dosage, 2.5/vial for every 10kg body weight.

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events
Number of Adverse Events

Secondary Outcome Measures

Left ventricle stroke volume
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
End diastolic volume
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc)
Left ventricular ejection fraction (LVEF)
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).
Participants Functional Activity by NYHA Classification
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.
Participants Functional Activity by CCS Classification
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.

Full Information

First Posted
August 6, 2019
Last Updated
October 6, 2023
Sponsor
Honya Medical Inc
Collaborators
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04050163
Brief Title
MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)
Acronym
MiSaver®
Official Title
Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Honya Medical Inc
Collaborators
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Heart Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Sequential dose escalating
Masking
Participant
Masking Description
Single/participant blinded
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Cells dosage, 1/vial for every 20kg body weight.
Arm Title
Intermediate Dose
Arm Type
Experimental
Arm Description
Cells dosage, 1/vial for every 10kg body weight.
Arm Title
Toxic Dose
Arm Type
Experimental
Arm Description
Cells dosage, 2.5/vial for every 10kg body weight.
Intervention Type
Biological
Intervention Name(s)
MiSaver®
Other Intervention Name(s)
stem cells
Intervention Description
Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Number of Adverse Events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Left ventricle stroke volume
Description
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
Time Frame
12 months
Title
End diastolic volume
Description
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc)
Time Frame
12 months
Title
Left ventricular ejection fraction (LVEF)
Description
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).
Time Frame
12 months
Title
Participants Functional Activity by NYHA Classification
Description
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.
Time Frame
12 months
Title
Participants Functional Activity by CCS Classification
Description
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.
Time Frame
12 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: 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
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
State/Province
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
HONYA Medical Inc
City
Tainan
ZIP/Postal Code
74147
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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