EPC by Intracoronary Injection in Patients With Chronic Stable Angina

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by TheraVitae Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mahidol University
Information provided by:
TheraVitae Ltd.
ClinicalTrials.gov Identifier:
NCT00384514
First received: October 5, 2006
Last updated: October 19, 2006
Last verified: October 2006
  Purpose

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

Condition Intervention Phase
Coronary Artery Disease
Device: VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors
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 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

Resource links provided by NLM:


Further study details as provided by TheraVitae Ltd.:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 24
Study Start Date: July 2004
Estimated Study Completion Date: September 2006
  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 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
  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: NCT00384514

Locations
Israel
Dr. Valentin Fulga
Kiryat Weizmann Science Park, Nes Zionna, Israel, 74140
Sponsors and Collaborators
TheraVitae Ltd.
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00384514     History of Changes
Other Study ID Numbers: TV-001
Study First Received: October 5, 2006
Last Updated: October 19, 2006
Health Authority: Thailand: The Ethical Committee on Research Involving Human Subject ,Faculty of Medicine Siriraj Hospital,Mahidol University,Bangkok

Keywords provided by TheraVitae Ltd.:
Coronary Artery disease with chronic stable angina

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014