MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Phase 1

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Biological: MCRcI® stem cells

• Registration Number: NCT04052191
• Lead Sponsor: Honya Medical Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Study Start: 2025-12-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low Dose	MCRcI® stem cells	Low Dose of MCRcI® stem cells.
Intermediate Dose	MCRcI® stem cells	Intermediate Dose of MCRcI® stem cells.
High Dose	MCRcI® stem cells	High Dose of MCRcI® stem cells.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events	6 months	Number of adverse events

Secondary Outcome Measures

Name	Time	Method
Left ventricle stroke volume	12 months	Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
End diastolic volume	12 months	Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)
Left ventricular ejection fraction (LVEF)	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.	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.

Trial Locations

Locations (1)

HONYA Medical Inc; 🇨🇳 Tainan, Taiwan