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

August 30, 2007 updated by: TheraVitae Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TheraVitae Ltd.

Investigators

  • Principal Investigator: Dan Tzivoni, MD, Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Anticipated)

August 1, 2007

Study Registration Dates

First Submitted

December 27, 2006

First Submitted That Met QC Criteria

December 27, 2006

First Posted (Estimate)

December 28, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2007

Last Update Submitted That Met QC Criteria

August 30, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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