Angina PectorisPhase 1/2NCT00416663
Vescell(TM) for the Treatment of Patients With Severe Anginal Syndrome With or Without Heart Failure
A Phase 1/2 study testing Intracoronary administration of autologous ACPs in people with Angina Pectoris, run by TheraVitae Ltd. at 1 site in Israel.
Trial summary
Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal drug treatment or not willing or without option of undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Intracoronary administration of autologous ACPs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to Aug 2007
- Phase
- Phase 1/2
- 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 or bridging collaterals to a patent distal segment supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery or bridging collaterals must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the VesCellTM if the vessel remains occluded despite the attempted angioplasty efforts (prior to or during the study angiography).
- Patients with occluded target coronary artery (with or without bridging collaterals) that could not be treated with PCI.
- 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 ACPs in the harvested blood).
- Inability to communicate (that may interfere with the clinical evaluation of the patient)
- STEMI during the preceding 3 months
- PCI+stenting during the preceding three months
- Significant valvular disease or after valve replacement
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- 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 temperature above 38.40C for 2 consecutive days
- Patient unlikely to be available for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study for Testing Efficacy and Safety of the Administration of Vescell(TM) (Blood-Borne Autologous Angiogenic Cell Precursors) to Alleviate Anginal Symptoms and Myocardial Ischemia in Severe Anginal Syndrome +/- Heart Failure
Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal drug treatment or not willing or without option of undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). The use of ACPs aims to promote the formation of new vascularization and thus viable myocardial tissue.
Read the detailed description
Ten adult patients with severe angina pectoris with or without heart failure and no therapeutic alternative will undergo screening and be treated with an injection of Angiogenic Cell Precursors (ACPs), contained in VesCell (TM). 250 ml of blood will be drawn from the patient and from this blood sample progenitor cells will be generated and differentiated into ACPs. The product will be administered into the obstructed coronary arteries using a catheter. Following injection, patients will be hospitalized for 24-48 hours in intensive care and later as required by their medical condition. Patients will return for follow up testing at one, three and six months following treatment.
- Conditions
- Angina Pectoris
- Being tested
- Intracoronary administration of autologous ACPs
- Keywords
- Stem cells, Progenitor cells, Angina Pectoris, Heart Failure, Angiogenesis
- Medical subject headings
- Angina Pectoris, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary administration of autologous ACPsProcedure or surgery
Also called VescellTM
Stem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | open label,single arm,intervention is Angiogenic Cell Precusors(ACPs) Receives: Procedure: Intracoronary administration of autologous ACPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the procedure as manifested in the post treatment observation and
Measured: 6 months
tests.
Measured: 6 months
Secondary outcomes (4)
Changes from baseline to 1, 3 and 6 months in the CCS.
Measured: 6 months
Changes from baseline to 1, 3 and 6 months of modified Bruce exercise test.
Measured: 6 months
Changes from baseline to 6 months of exercise-induced ischemia on Sestamibi scan.
Measured: 6 months
Changes from baseline to 6 months of %LVEF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startAug 2007
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TheraVitae Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Tzivoni, MD, Principal investigator, Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416663
- Sponsor's protocol ID
- TV-013
- Status last verified
- Dec 2006
- First submitted
- 27 Dec 2006
- Last updated
- 3 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Porat Y, Porozov S, Belkin D, Shimoni D, Fisher Y, Belleli A, Czeiger D, Silverman WF, Belkin M, Battler A, Fulga V, Savion N. Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages. Br J Haematol. 2006 Dec;135(5):703-14. doi: 10.1111/j.1365-2141.2006.06344.x.
PubMed 17052254
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Testing Efficacy and Safety of the Administration of Vescell(TM) (Blood-Borne Autologous Angiogenic Cell Precursors) to Alleviate Anginal Symptoms and Myocardial Ischemia in Severe Anginal Syndrome +/- Heart Failure
- ClinicalTrials.gov ID
- NCT00416663
- Acronym / sponsor ID
- TV-013
- Conditions
- Angina Pectoris
- Keywords
- Stem cells, Progenitor cells, Angina Pectoris, Heart Failure, Angiogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- TheraVitae Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Study completion
- Aug 2007 (estimated)
- First posted
- 28 Dec 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.
Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal drug treatment or not willing or without option of undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). The use of ACPs aims to promote the formation of new vascularization and thus viable myocardial tissue.
Detailed description
Ten adult patients with severe angina pectoris with or without heart failure and no therapeutic alternative will undergo screening and be treated with an injection of Angiogenic Cell Precursors (ACPs), contained in VesCell (TM). 250 ml of blood will be drawn from the patient and from this blood sample progenitor cells will be generated and differentiated into ACPs. The product will be administered into the obstructed coronary arteries using a catheter. Following injection, patients will be hospitalized for 24-48 hours in intensive care and later as required by their medical condition. Patients will return for follow up testing at one, three and six months following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: Intracoronary administration of autologous ACPsopen label,single arm,intervention is Angiogenic Cell Precusors(ACPs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery or bridging collaterals to a patent distal segment supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery or bridging collaterals must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the VesCellTM if the vessel remains occluded despite the attempted angioplasty efforts (prior to or during the study angiography).
- Patients with occluded target coronary artery (with or without bridging collaterals) that could not be treated with PCI.
- 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
Key exclusion criteria (19 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 ACPs in the harvested blood).
- Inability to communicate (that may interfere with the clinical evaluation of the patient)
- STEMI during the preceding 3 months
- PCI+stenting during the preceding three months
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 |
|---|---|---|
| Intracoronary administration of autologous ACPsAlso: VescellTMStem cells type:ACPs. At least 1.5 million of ACPs per one time of treatment | Procedure or surgery | single arm |
Primary outcome
Safety of the procedure as manifested in the post treatment observation and
Time frame: 6 months
tests.
Time frame: 6 months
4 secondary outcomes
Changes from baseline to 1, 3 and 6 months in the CCS.
Time frame: 6 months
Changes from baseline to 1, 3 and 6 months of modified Bruce exercise test.
Time frame: 6 months
Changes from baseline to 6 months of exercise-induced ischemia on Sestamibi scan.
Time frame: 6 months
Changes from baseline to 6 months of %LVEF
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2007.
- Background: PubMed 17052254Porat Y, Porozov S, Belkin D, Shimoni D, Fisher Y, Belleli A, Czeiger D, Silverman WF, Belkin M, Battler A, Fulga V, Savion N. Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages. Br J Haematol. 2006 Dec;135(5):703-14. doi: 10.1111/j.1365-2141.2006.06344.x.
- Shaare Zedek Medical CenterLink provided by the sponsor.
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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.
Dan Tzivoni, MD principal investigator
Director, Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intracoronary administration of autologous ACPs in people with Angina Pectoris, 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 8 inclusion and 19 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 3 Sep 2007. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Astrid Rojansky, M.H.A. (+972-(0)2-6555956, astrid@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the procedure as manifested in the post treatment observation and (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT00416663, which also lists 1 linked publication.
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 3 Sep 2007.