Coronary Artery DiseasePhase 2NCT00384514
EPC by Intracoronary Injection in Patients With Chronic Stable Angina
A Phase 2 study testing VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors in people with Coronary Artery Disease, run by TheraVitae Ltd. at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2004to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Dr. Valentin Fulga
Kiryat Weizmann Science Park, Nes Zionna, 74140
About this study
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
Read more
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
- Conditions
- Coronary Artery Disease
- Being tested
- VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors
- Keywords
- Coronary Artery disease with chronic stable angina
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VesCell (TM)-Autologous EPCs/Angiogenic Cell PrecursorsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJul 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- TheraVitae Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mahidol University
- Investigators
- Damras Tresukosol, M.D., Principal investigator, Head of Cardiac Catherlization unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj Hospital,Mahidol University ,BKK,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384514
- Sponsor's protocol ID
- TV-001
- Status last verified
- Oct 2006
- First submitted
- 5 Oct 2006
- Last updated
- 20 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00384514
- Acronym / sponsor ID
- TV-001
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery disease with chronic stable angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants
- Lead sponsor
- TheraVitae Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mahidol University
- Study start
- Jul 2004
- Study completion
- Sep 2006
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors | Device | – |
Primary outcome
Safety : no.& duration of adverse event & serious adverse event
Efficacy :change from baseline to 1,3,6 months of CCS, 6-minute walking test
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damras Tresukosol, M.D. principal investigator
Head of Cardiac Catherlization unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj Hospital,Mahidol University ,BKK,Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VesCell (TM)-Autologous EPCs/Angiogenic Cell Precursors in people with Coronary Artery Disease, run by TheraVitae Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety : no.& duration of adverse event & serious adverse event. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2006.