MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Biological: MCRcI® stem cells


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>Low Dose of MCRcI® stem cells. | Biological: MCRcI® stem cells<br>* Intra-Coronary Administration of MCRcI® stem cells<br>* Other names: stem cells;|
| Experimental: Intermediate Dose<br>Intermediate Dose of MCRcI® stem cells. | Biological: MCRcI® stem cells<br>* Intra-Coronary Administration of MCRcI® stem cells<br>* Other names: stem cells;|
| Experimental: High Dose<br>High Dose of MCRcI® stem cells. | Biological: MCRcI® stem cells<br>* Intra-Coronary Administration of MCRcI® stem cells<br>* Other names: stem cells;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events | Number of adverse events | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle stroke volume | Echocardiogram assessment on left ventricle stroke volume (volume of blood pumped from the left ventricle per beat (ml). | 12 months | 
| End diastolic volume | Echocardiogram assessment on volume of blood in the left ventricle at the end of diastolic filling (ml) | 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). | 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. | 12 months |