MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— MCRcI®  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04052191
• Other study ID #: KCG17121910001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Honya Medical Inc
• Contact: Jackson TK Liu, MD
• Phone: +886921167980
• Email: honyamedical[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Taiwan	HONYA Medical Inc	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Honya Medical Inc	Chang Gung Memorial Hospital

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	6 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 (ml)	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	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.	12 months