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

NCT00416663 | Unknown Phase 1 DMC

• 1 other identifier: TV-013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris

Keywords

Stem cells; Progenitor cells; Angina Pectoris; Heart Failure; Angiogenesis

Outcome Measures

Primary Outcomes (2)

• Safety of the procedure as manifested in the post treatment observation and

  6 months

• tests.

  6 months

Secondary Outcomes (4)

• 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

Study Arms (1)

single arm

EXPERIMENTAL

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

Procedure: Intracoronary administration of autologous ACPs

Interventions

Intracoronary administration of autologous ACPs PROCEDURE

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

Also known as: VescellTM

single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TheraVitae Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

• 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.

  PMID: 17052254 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dan Tzivoni, MD

  Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid Rojansky, M.H.A.

CONTACT

+972-(0)2-6555956; astrid@szmc.org.il

Danny Belkin, Ph.D.

CONTACT

+972-(0)8-9409170; dbelkin@theravitae.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 3, 2007

Record last verified: 2006-12

Locations

IL (1)