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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MESENDO | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by laboratory assessments, ecg, temperature and holter monitor | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by SPECT scan and 2-D Echo | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCA Cellular Therapy, LLC | Covington | Louisiana | 70433 | United States |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |