Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated. Coronary ischemia is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart. CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina. The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart. Patients eligible to participate in this study are those suffering from severe blockages to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures. Once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart. Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works. Patients will be evaluated for 6 months after cell transplant.

Official Title
-----------------
Phase I Study to See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia

Conditions
-----------------
Coronary Ischemia, Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Coronary Arteriosclerosis

Intervention / Treatment
-----------------
* Biological: MESENDO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female age 18-20 Angina Pectoris: CCS Class II or IV or angina symptom equivalent 70% blockage in at least one epicardial vessel documented within 6 months Stable medical therapy Reversible perfusion defects by SPECT Not a candidate for percutaneous intervention or coronary by-pass surgery Exclusion Criteria: Previous angiogenic therapy or myocardial laser therapy Severe valvular heart disease Recent malignancy or radiation therapy within 6 months Renal insufficiency with creatinine greater that 2.7 White blood count greater than 13,000 or lower than 3,000 Platelet count lower than 60,000 or higher that 500,000 Pregnant or planning to become pregnant History of skeletal muscle disease AST or ALT greater than two times upper limit of normal

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MESENDO|2 ml of the final cell mixture will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by laboratory assessments, ecg, temperature and holter monitor |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by SPECT scan and 2-D Echo |  | 6 months |