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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | open label,single arm,intervention is Angiogenic Cell Precusors(ACPs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary administration of autologous ACPs | Procedure | Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the procedure as manifested in the post treatment observation and | 6 months | |
| tests. | 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astrid Rojansky, M.H.A. | Contact | +972-(0)2-6555956 | astrid@szmc.org.il | |
| Danny Belkin, Ph.D. | Contact | +972-(0)8-9409170 | 18 | dbelkin@theravitae.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Tzivoni, MD | Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17052254 | Background | Porat Y, Porozov S, Belkin D, Shimoni D, Fisher Y, Belleli A, Czeiger D, Silverman WF, Belkin M, Battler A, Fulga V, Savion N. Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages. Br J Haematol. 2006 Dec;135(5):703-14. doi: 10.1111/j.1365-2141.2006.06344.x. |
| Label | URL |
|---|---|
| Shaare Zedek Medical Center | View source |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 6 months |
| Changes from baseline to 6 months of %LVEF | 6 months |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |