Vescell(TM) for the Treatment of Patients With Severe Anginal Syndrome With or Without Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study for Testing Efficacy and Safety of the Administration of Vescell(TM) (Blood-Borne Autologous Angiogenic Cell Precursors) to Alleviate Anginal Symptoms and Myocardial Ischemia in Severe Anginal Syndrome +/- Heart Failure

Conditions
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Angina Pectoris

Intervention / Treatment
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* Procedure: Intracoronary administration of autologous ACPs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery or bridging collaterals to a patent distal segment supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery or bridging collaterals must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the VesCellTM if the vessel remains occluded despite the attempted angioplasty efforts (prior to or during the study angiography). Patients with occluded target coronary artery (with or without bridging collaterals) that could not be treated with PCI. Patients are not candidates for or are not willing to undergo CABG surgery. Age 18 to 80 years Male or non-pregnant, non-lactating female Ejection fraction >35% on Sestamibi Sestamibi scan (myocardial perfusion) during exercise or dipyridamole, demonstrating regional reversible ischemia in an area relating to the occluded coronary artery. Informed consent obtained and consent form signed Exclusion Criteria: Patients not satisfying the coronary angiography and Sestamibi criteria. Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood). Inability to communicate (that may interfere with the clinical evaluation of the patient) STEMI during the preceding 3 months PCI+stenting during the preceding three months Significant valvular disease or after valve replacement After heart transplantation Cardiomyopathy Renal failure (creatinine 10% above the upper limit according to the hospital normograms) Hepatic failure Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male) Abnormal coagulation tests normal [platelets, PT (INR), PTT] Stroke within the preceding 3 years Malignancy within the preceding 3 years Concurrent chronic or acute infectious disease Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, insulin-dependent diabetes mellitus, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis) Chronic immunomodulating or cytotoxic drugs treatment Patients who have rectal temperature above 38.40C for 2 consecutive days Patient unlikely to be available for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>open label,single arm,intervention is Angiogenic Cell Precusors(ACPs) | Procedure: Intracoronary administration of autologous ACPs<br>* Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment<br>* Other names: VescellTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the procedure as manifested in the post treatment observation and |  | 6 months | 
| tests. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to 1, 3 and 6 months in the CCS. |  | 6 months | 
| Changes from baseline to 1, 3 and 6 months of modified Bruce exercise test. |  | 6 months | 
| Changes from baseline to 6 months of exercise-induced ischemia on Sestamibi scan. |  | 6 months | 
| Changes from baseline to 6 months of %LVEF |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cells, Progenitor cells, Angina Pectoris, Heart Failure, Angiogenesis