Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384514
Status:
UNKNOWN
Last Update Posted:
2006-10-20
First Post:
2006-10-05
Brief Title:
EPC by Intracoronary Injection in Patients With Chronic Stable Angina
Sponsor:
TheraVitae Ltd
Organization:
TheraVitae Ltd
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study titleA 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 DamrasTresukosolMDHead of Cardiac Catherlization unitDivision of CardiologyDepartment of MedicineFaculty of Medicine Siriraj HospitalMahidol 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 centera non-randomizedopen-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 angiographythe 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 dipyridamoledemonstrating 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 15 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 periodsScreening D-14to-9D-8TreatmentD0Acute Safety follow-up D1D2Chronic follow-up D30D90D180period 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 136 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 timeexercise-induced ischemia METs on Sesta-mibi scan Duration of study July 2004-December 2006
Principle Investigator Assoc Prof DamrasTresukosolMDHead of Cardiac Catherlization unitDivision of CardiologyDepartment of MedicineFaculty of Medicine Siriraj HospitalMahidol 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 centera non-randomizedopen-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 angiographythe 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 dipyridamoledemonstrating 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 15 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 periodsScreening D-14to-9D-8TreatmentD0Acute Safety follow-up D1D2Chronic follow-up D30D90D180period 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 136 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 timeexercise-induced ischemia METs on Sesta-mibi scan Duration of study July 2004-December 2006
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None