EPC by Intracoronary Injection in Patients With Chronic Stable Angina

October 19, 2006 updated by: TheraVitae Ltd.

A Study for Testing Safety and Efficacy of the Administration of Blood-Borne Autologous Endothelial Progenitor Cells to Alleviate Anginal Symptoms and Myocardial Ischemia in Patients With Severe Anginal Syndrome

Study title:A Study for Testing Safety and Efficacy of the administration of Blood-Borne Autologous Endothelial Progenitor Cells to Alleviate Anginal Symptoms and Myocardial Ischemia in Patients with Severe Anginal Syndrome

Principle Investigator: Assoc. Prof. Damras,Tresukosol,M.D.,Head of Cardiac Catherlization unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj Hospital,Mahidol University

Study objective : To determine the safety and efficacy of intracoronary injection of blood-borne autologous EPCs in relieving symptoms of angina pectoris in symptomatic patients treated with maximal medical therapy with an occluded coronary artery supplying ischemic myocardium Study Design : Phase II, a single center,a non-randomized,open-label trial,

Study population :

Total expected no. of patients : 24

main selection criteria :

  • Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery supplying an ischemic viable myocardial region as shown on Sesta-mibi scan. On coronary angiography,the occluded coronary artery must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the EPC if the vessel remains occluded despite the attempted angioplasty efforts.
  • Age 18-80 years
  • Ejection fraction >35 % on Sesta-mibi scan
  • Sestamibi scan (myocardial perfusion) during exercise or dipyridamole,demonstrating regional reversible ischemia in an area relating to the occluded coronary artery.

Investigational Product : At D-8 250 ml of blood drawn from the patients for production of autologous EPCs or ACPs (VescellTM), On D0 ,at least 1.5 million EPCs with viability >75 % suspended in 6 ml sterile cell culture medium will be injected to the same patients by intracoronary artery.

The study consists of 4 periods:Screening ( D-14to-9&D-8,Treatment(D0),Acute Safety follow-up (D1&D2),Chronic follow-up (D30,D90&D180)period ,total follow-up of each case is 6 months.

Evaluation criteria :

Safety : no.& duration of adverse event & serious adverse event

Efficacy :

  • change from baseline to 1,3,6 months of CCS, 6-minute walking test
  • change from baseline to 3 & 6 months of Sesta-mibi scan
  • change from baseline to 3 & 6 months of symptom-limited exercise time,exercise-induced ischemia & METs on Sesta-mibi scan Duration of study: July 2004-December 2006

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Israel
      • Kiryat Weizmann Science Park, Nes Zionna, Israel, 74140
        • Dr. Valentin Fulga

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 supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the EPC if the vessel remains occluded despite the attempted angioplasty efforts.
  • 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 EPCs in the harvested blood).
  • Inability to communicate (that may interfere with the clinical evaluation
  • Myocardial infarction during the preceding 3 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 temp. 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety : no.& duration of adverse event & serious adverse event
Efficacy :change from baseline to 1,3,6 months of CCS, 6-minute walking test

Secondary Outcome Measures

Outcome Measure
Efficacy : change from baseline to 3 & 6 months of Sesta-mibi scan
: change from baseline to 3 & 6 months of symptom-limited exercise time,exercise-induced ischemia & METs on Sesta-mibi scan

Collaborators and Investigators

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

Sponsor

TheraVitae Ltd.

Collaborators

Mahidol University

Investigators

  • Principal Investigator: Damras Tresukosol, M.D., Head of Cardiac Catherlization unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj Hospital,Mahidol University ,BKK,Thailand

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

July 1, 2004

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

October 5, 2006

First Submitted That Met QC Criteria

October 5, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

October 20, 2006

Last Update Submitted That Met QC Criteria

October 19, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV-001

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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