Coronary Artery Disease
Conditions
Brief summary
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
Interventions
BIOLOGICALMCRcI® stem cells
Intra-Coronary Administration of MCRcI® stem cells
Sponsors
Chang Gung Memorial Hospital
Honya Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant blind with dose.
Intervention model description
Dose escalation.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | 6 months | Number of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactJackson TK Liu, MD
Outcome results
None listed