MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

NCT04052191 — Phase 1, Not yet recruiting, 40 participants, Honya Medical Inc

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

Registry	NCT04052191, acronym MCRcI®
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: single, treatment
Enrollment	40 (Estimated)
Sponsor	Honya Medical Inc (Industry); collaborators: Chang Gung Memorial Hospital
Conditions	Coronary Artery Disease
Interventions	MCRcI® stem cells (Biological)
Dates	start 2025-12-01 (estimated), primary completion 2026-01-01 (estimated), completion 2026-12-01 (estimated), first posted 2019-08-09, last updated 2024-10-03
Locations	1 site in Taiwan

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Low Dose	Experimental	Biological: MCRcI® stem cells	Low Dose of MCRcI® stem cells.
Intermediate Dose	Experimental	Biological: MCRcI® stem cells	Intermediate Dose of MCRcI® stem cells.
High Dose	Experimental	Biological: MCRcI® stem cells	High Dose of MCRcI® stem cells.

MCRcI® stem cells (Biological), also known as stem cells: Intra-Coronary Administration of MCRcI® stem cells

+Outcome measures

Primary outcomes

Incidence of Treatment Emergent Adverse Events [6 months]: Number of adverse events

Secondary outcomes

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.

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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)

Facility	City	Country	Status
HONYA Medical Inc	Tainan	Taiwan

+Investigators

Fang Y Lee, MD, Principal investigator, Chang Gung Memorial Hospital

My Notes

Public

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