A Phase 1 interventional study of MESENDO in Coronary Ischemia, Coronary Disease and Coronary Artery Disease, sponsored by TCA Cellular Therapy. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-04-28.
Sponsored by TCA Cellular Therapy · Phase 1, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 10 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →TCA Cellular Therapy is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Safety as measured by laboratory assessments, ecg, temperature and holter monitor
Time frame: 2 weeks
Efficacy as measured by SPECT scan and 2-D Echo
Time frame: 6 months
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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TCA Cellular Therapy