Coronary Artery Disease Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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