Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal drug treatment or not willing or without option of undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). The use of ACPs aims to promote the formation of new vascularization and thus viable myocardial tissue.
Ten adult patients with severe angina pectoris with or without heart failure and no therapeutic alternative will undergo screening and be treated with an injection of Angiogenic Cell Precursors (ACPs), contained in VesCell (TM). 250 ml of blood will be drawn from the patient and from this blood sample progenitor cells will be generated and differentiated into ACPs. The product will be administered into the obstructed coronary arteries using a catheter. Following injection, patients will be hospitalized for 24-48 hours in intensive care and later as required by their medical condition. Patients will return for follow up testing at one, three and six months following treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment
Shaare Zedek Medical Center
Jerusalem, Israel
Safety of the procedure as manifested in the post treatment observation and
Time frame: 6 months
tests.
Time frame: 6 months
Changes from baseline to 1, 3 and 6 months in the CCS.
Time frame: 6 months
Changes from baseline to 1, 3 and 6 months of modified Bruce exercise test.
Time frame: 6 months
Changes from baseline to 6 months of exercise-induced ischemia on Sestamibi scan.
Time frame: 6 months
Changes from baseline to 6 months of %LVEF
Time frame: 6 months
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