MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Phase 1Not Yet RecruitingNCT04052191

Honya Medical Inc40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

MCRcI® stem cellsBIOLOGICAL

Intra-Coronary Administration of MCRcI® stem cells

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

HONYA Medical Inc

Tainan, Taiwan

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events

Number of adverse events

Time frame: 6 months

Secondary Outcomes

Left ventricle stroke volume

Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).

Time frame: 12 months

End diastolic volume

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

Time frame: 12 months

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).

Time frame: 12 months

Severity of angina symptom using Canadian Cardiovascular Society grading.

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.

Time frame: 12 months

Central Contacts

Jackson TK Liu, MD

CONTACT

+886921167980 honyamedical@gmail.com

Data from ClinicalTrials.gov

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