MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Overview

Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.

Full Title of Study: “Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2020

Interventions

  • Biological: MCRcI® stem cells
    • Intra-Coronary Administration of MCRcI® stem cells

Arms, Groups and Cohorts

  • Experimental: Low Dose
    • Low Dose of MCRcI® stem cells.
  • Experimental: Intermediate Dose
    • Intermediate Dose of MCRcI® stem cells.
  • Experimental: High Dose
    • High Dose of MCRcI® stem cells.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Treatment Emergent Adverse Events
    • Time Frame: 6 months
    • Number of adverse events

Secondary Measures

  • 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).
  • End diastolic volume
    • Time Frame: 12 months
    • Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)
  • 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).
  • Severity of angina symptom using Canadian Cardiovascular Society grading.
    • Time Frame: 12 months
    • Canadian Cardiovascular Society grading of angina pectoris is a classification system used to grade the severity of exertional angina. Scale ranges 0 ~ IV (most sever), with 0 Asymptomatic Angina, I Angina only with strenuous exertion, II Angina with moderate exertion, III Angina with mild exertion and IV Angina at rest.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with Diffuse Coronary Artery Disease
  • Age 20~80
  • Participants have received proper medication
  • Canadian Cardiovascular Society class II- IV Angina.

Exclusion Criteria

  • Age <20 or >80
  • Pregnant or breast feeding
  • Positive adventitious infection (such as HIV, hepatitis )
  • History of Myocardial Infarction within past 3 months
  • Severe aortic or mitral valve narrowing
  • 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
  • Kiney disease on renal dialysis.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Honya Medical Inc
  • Collaborator
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fang Y Lee, MD, Principal Investigator, Chang Gung Memorial Hospital
  • Overall Contact(s)
    • Jackson TK Liu, MD, +886921167980, honyamedical@gmail.com

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