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

Myocardial Infarction Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050163
• Other study ID #: csho19052112001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 26, 2021
• Est. completion date: May 4, 2023

Study information

• Verified date: March 2024
• Source: Honya Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung	Taichung City
Taiwan	HONYA Medical Inc	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Honya Medical Inc	Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events	Number of Adverse Events	12 months
Secondary	Left ventricle stroke volume	Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).	12 months
Secondary	End diastolic volume	Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (cc)	12 months
Secondary	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).	12 months
Secondary	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.	12 months
Secondary	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.	12 months