Trials / Completed
CompletedNCT00643981
Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia
Phase I Study to See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- TCA Cellular Therapy · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Coronary Ischemia
- Coronary Disease
- Coronary Artery Disease
- Coronary Atherosclerosis
- Coronary Arteriosclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-12-01
- Completion
- 2009-02-01
- First posted
- 2008-03-26
- Last updated
- 2011-04-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00643981. Inclusion in this directory is not an endorsement.