Not yet recruiting NCT04052191
MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MCRcI® stem cells.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intra-Coronary Administration of MCRcI® (Myo-Cardial Regenerative Cellular Injection) Improves Left Ventricular Function in Patients With Diffuse Coronary Artery Disease
Overview
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
Interventions
- Biological MCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Primary outcome measures
- Incidence of Treatment Emergent Adverse Events [Time frame: 6 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- HONYA Medical Inc — Tainan
Identifiers
NCT: NCT04052191 · KCG17121910001