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

Sponsor

TheraVitae Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00416663

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris	Procedure: Intracoronary administration of autologous ACPs	Phase 1/Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Anticipated Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm open label,single arm,intervention is Angiogenic Cell Precusors(ACPs)	Procedure: Intracoronary administration of autologous ACPs Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment Other Names: VescellTM

Arm

Intervention/Treatment

Experimental: single arm

open label,single arm,intervention is Angiogenic Cell Precusors(ACPs)

Procedure: Intracoronary administration of autologous ACPs

Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment

Other Names:

VescellTM

Outcome Measures

Primary Outcome Measures

Safety of the procedure as manifested in the post treatment observation and [6 months]
tests. [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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