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

NCT04050163 | Completed Phase 1 DMC

• 1 other identifier: csho19052112001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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)

Conditions

Myocardial Infarction

Keywords

Heart Attack

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Number of Adverse Events

  12 months

Secondary Outcomes (5)

• Left ventricle stroke volume

  12 months

• End diastolic volume

  12 months

• Left ventricular ejection fraction (LVEF)

  12 months

• Participants Functional Activity by NYHA Classification

  12 months

• Participants Functional Activity by CCS Classification

  12 months

Study Arms (3)

Low Dose

EXPERIMENTAL

Cells dosage, 0.5x10\^7 cells/kg body weight

Biological: MiSaver®

Intermediate Dose (aka Effective or High)

EXPERIMENTAL

Cells dosage, 1.6x10\^7 cells/kg body weight

Biological: MiSaver®

Toxic Dose

EXPERIMENTAL

Cells dosage, 5.0 x10\^7 cells/kg body weight

Biological: MiSaver®

Interventions

MiSaver® BIOLOGICAL

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

Also known as: stem cells

Intermediate Dose (aka Effective or High); Low Dose; Toxic Dose

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Honya Medical Inc: lead
• Chung Shan Medical University: collaborator

Study Sites (2)

Chung Shan Medical University Hospital

Taichung, Taichung City, 402, Taiwan

Location

HONYA Medical Inc

Tainan, 74147, Taiwan

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single/participant blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential dose escalating

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: January 26, 2021
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)