Coronary Artery Disease Clinical Trial
Official title:
Phase II Study for the Transfer of Bone Marrow-Derived Mononuclear and Mesenchymal StemCells Into the Myocardium for the Treatment of Severe Coronary Ischemia
The present investigation will be a Phase II, single center, placebo-controlled, randomized,
dose escalation, infusion modality (intracoronary vs transendocardial injection using the
Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular
injection catheter) transplantation of an autologous (your own stem cells) combination of
bone marrow-derived stem cells into myocardium 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(CI).
In this trial we will determine whether the combination stem cell treatment is safe,
feasible and results in the development of mature stable and/or collateral vessels and
improvement of cardiac function.
Coronary Ischemia (CI) 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 of
the vessels of the heart and are not candidates for percutaneous revascularization or
surgical procedures.
Enrolled individuals (60) will be divided in 2 Treatment groups for the infusion of the cell
/placebo product:
1. Treatment Group A (30 individuals, including patients and placebo controls) will
receive the product by intracoronary infusion,
2. Treatment Group B (30 individuals, including patients and placebo controls) will
receive the product by transendocardial injections.
In turn, each Treatment Group will consist of 2 subgroups of individuals that will
receive the infusion of one of the two doses established of the cell product:
3. In treatment SubGroup 1, 10 individuals will receive the "low dose" of the cell product
and 5 individuals will receive the placebo product.
4. In treatment SubGroup 2, 10 individuals will receive the "high dose" of the cell
product and 5 individuals will receive the placebo product
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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