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
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | September 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Dr. Valentin Fulga | Kiryat Weizmann Science Park, Nes Zionna |
Lead Sponsor | Collaborator |
---|---|
TheraVitae Ltd. | Mahidol University |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety : no.& duration of adverse event & serious adverse event | |||
Primary | Efficacy :change from baseline to 1,3,6 months of CCS, 6-minute walking test | |||
Secondary | Efficacy : change from baseline to 3 & 6 months of Sesta-mibi scan | |||
Secondary | : change from baseline to 3 & 6 months of symptom-limited exercise time,exercise-induced ischemia & METs on Sesta-mibi scan |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |