Coronary Artery Disease Clinical Trial
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
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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