MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease
MCRcI®
Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 coronary-artery-disease
Started Dec 2025
Shorter than P25 for phase_1 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedOctober 3, 2024
October 1, 2024
1 month
August 6, 2019
October 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment Emergent Adverse Events
Number of adverse events
6 months
Secondary Outcomes (4)
Left ventricle stroke volume
12 months
End diastolic volume
12 months
Left ventricular ejection fraction (LVEF)
12 months
Severity of angina symptom using Canadian Cardiovascular Society grading.
12 months
Study Arms (3)
Low Dose
EXPERIMENTALLow Dose of MCRcI® stem cells.
Intermediate Dose
EXPERIMENTALIntermediate Dose of MCRcI® stem cells.
High Dose
EXPERIMENTALHigh Dose of MCRcI® stem cells.
Interventions
Intra-Coronary Administration of MCRcI® stem cells
Eligibility Criteria
You may qualify if:
- Patients with Diffuse Coronary Artery Disease
- Age 20\~80
- Participants have received proper medication
- Canadian Cardiovascular Society class II- IV Angina.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Honya Medical Inclead
- Chang Gung Memorial Hospitalcollaborator
Study Sites (1)
HONYA Medical Inc
Tainan, 74147, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fang Y Lee, MD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant blind with dose.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 9, 2019
Study Start
December 1, 2025
Primary Completion
January 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 3, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share