Coronary Artery DiseasePhase 1MCRcI®NCT04052191
MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease
A Phase 1 study testing MCRcI® stem cells in people with Coronary Artery Disease, run by Honya Medical Inc at 1 site in Taiwan.
Trial summary
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- MCRcI® stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Diffuse Coronary Artery Disease
- Age 20~80
- Participants have received proper medication
- Canadian Cardiovascular Society class II- IV Angina.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
HONYA Medical Inc
Tainan, 74147
Jackson TK Liu, MD, +88665055006, info@honyamedical.com
About this study
Official title: Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
- Conditions
- Coronary Artery Disease
- Being tested
- MCRcI® stem cells
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCRcI® stem cellsBiological
Also called stem cells
Intra-Coronary Administration of MCRcI® stem cells
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Low Dose of MCRcI® stem cells. Receives: Biological: MCRcI® stem cells |
| Intermediate Dose | Experimental | Intermediate Dose of MCRcI® stem cells. Receives: Biological: MCRcI® stem cells |
| High Dose | Experimental | High Dose of MCRcI® stem cells. Receives: Biological: MCRcI® stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Number of adverse events
Measured: 6 months
Secondary outcomes (4)
Left ventricle stroke volume
Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml).
Measured: 12 months
End diastolic volume
Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml)
Measured: 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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Honya Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Fang Y Lee, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052191
- Sponsor's protocol ID
- KCG17121910001
- Acronym
- MCRcI®
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2019
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04052191
- Acronym / sponsor ID
- MCRcI® / KCG17121910001
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Honya Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: MCRcI® stem cellsLow Dose of MCRcI® stem cells. |
| Intermediate Dose | Experimental | Biological: MCRcI® stem cellsIntermediate Dose of MCRcI® stem cells. |
| High Dose | Experimental | Biological: MCRcI® stem cellsHigh Dose of MCRcI® stem cells. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Diffuse Coronary Artery Disease
- Age 20~80
- Participants have received proper medication
- Canadian Cardiovascular Society class II- IV Angina.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCRcI® stem cellsAlso: stem cellsIntra-Coronary Administration of MCRcI® stem cells | Biological | High Dose, Intermediate Dose, Low Dose |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: 6 months
Number of adverse events
4 secondary outcomes
Left ventricle stroke volume
Time frame: 12 months
End diastolic volume
Time frame: 12 months
Left ventricular ejection fraction (LVEF)
Time frame: 12 months
Severity of angina symptom using Canadian Cardiovascular Society grading.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Y Lee, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCRcI® stem cells in people with Coronary Artery Disease, run by Honya Medical Inc at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jackson TK Liu, MD (+886921167980, honyamedical@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.