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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by TheraVitae Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
TheraVitae Ltd.
ClinicalTrials.gov Identifier:
NCT00416663
First received: December 27, 2006
Last updated: August 30, 2007
Last verified: December 2006
  Purpose

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 Intervention Phase
Angina Pectoris
Procedure: Intracoronary administration of autologous ACPs
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TheraVitae Ltd.:

Primary Outcome Measures:
  • Safety of the procedure as manifested in the post treatment observation and [ Time Frame: 6 months ]
  • tests. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: August 2007
Estimated Study Completion Date: August 2007
Arms Assigned Interventions
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 Name: VescellTM

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416663

Contacts
Contact: Astrid Rojansky, M.H.A. +972-(0)2-6555956 astrid@szmc.org.il
Contact: Danny Belkin, Ph.D. +972-(0)8-9409170 ext 18 dbelkin@theravitae.com

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Sponsors and Collaborators
TheraVitae Ltd.
Investigators
Principal Investigator: Dan Tzivoni, MD Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00416663     History of Changes
Other Study ID Numbers: TV-013
Study First Received: December 27, 2006
Last Updated: August 30, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by TheraVitae Ltd.:
Stem cells
Progenitor cells
Angina Pectoris
Heart Failure
Angiogenesis

Additional relevant MeSH terms:
Angina Pectoris
Heart Failure
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014