Coronary Artery DiseasePhase 1/2PROGENITORNCT00694642
Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
A Phase 1/2 study testing Selected CD 133+ cells in people with Coronary Artery Disease and Refractory Angina, run by Pilar Jimenez Quevedo at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Refractory Angina
- What is being tested?
- Selected CD 133+ cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- May 2008to Feb 2012
- 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
- Functional class II- IV angina on maximal medical therapy
- Myocardial Ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques
- Patients should not be amenable to any type of revascularization procedure (percutaneous or surgical)
- Signed informed consent
Who cannot join
- Age <18 years or >75 years.
- Atrial fibrillation.
- LV thrombus
- Acute myocardial infarction in the last 3 months
- An LV wall thickness of <8 mm at the target site for cell injection
- A history of malignancy in the last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.
Read the detailed description
The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.
- Conditions
- Coronary Artery Disease, Refractory Angina
- Being tested
- Selected CD 133+ cells
- Keywords
- Refractory angina
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected CD 133+ cellsBiological
Endothelial progenitor cell CD 133
| Study group | Role | What they receive |
|---|---|---|
| selected CD133+cells | Active comparator | Transendocardial injection of selected CD133+cells Receives: Biological: Selected CD 133+ cells |
| no injection | No intervention | Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac and cerebrovascular event
cardiovascular death, non-fatal myocardial infarction (MI), ischemic stroke, need for revascularization or , procedure-related complications (: pericardial effusion/cardiac tamponade, vascular complications and sustained ventricular arrhythmias).
Measured: 6, 12 and 24 months
Secondary outcomes (1)
Efficacy
The change in the myocardial perfusion defect at baseline versus follow-up measured by Single Photon Emission Computed Tomography (SPECT). Treadmill test, and clinical evaluation (CCS, nº angina episodes/month, nº nitroglycerin /month, Quality of life by seattle questionnaire)
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 posted10 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionFeb 2012
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pilar Jimenez Quevedo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Responsible party
- Sponsor-investigator, Pilar Jimenez Quevedo, Hospital San Carlos, Madrid
- Investigators
- Pilar Jimenez-Quevedo, MD,PhD, Principal investigator, Hostpial Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694642
- Sponsor's protocol ID
- progenitorCD133
- Acronym
- PROGENITOR
- Status last verified
- May 2008
- First submitted
- 5 Jun 2008
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
- ClinicalTrials.gov ID
- NCT00694642
- Acronym / sponsor ID
- PROGENITOR / progenitorCD133
- Conditions
- Coronary Artery Disease, Refractory Angina
- Keywords
- Refractory angina
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pilar Jimenez QuevedoUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Jun 2008 (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.
The purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.
Detailed description
The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selected CD133+cells | Active comparator | Biological: Selected CD 133+ cellsTransendocardial injection of selected CD133+cells |
| no injection | No intervention | –Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Functional class II- IV angina on maximal medical therapy
- Myocardial Ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques
- Patients should not be amenable to any type of revascularization procedure (percutaneous or surgical)
- Signed informed consent
Key exclusion criteria (6 listed)
- Age <18 years or >75 years.
- Atrial fibrillation.
- LV thrombus
- Acute myocardial infarction in the last 3 months
- An LV wall thickness of <8 mm at the target site for cell injection
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 |
|---|---|---|
| Selected CD 133+ cellsEndothelial progenitor cell CD 133 | Biological | selected CD133+cells |
Primary outcome
major adverse cardiac and cerebrovascular event
Time frame: 6, 12 and 24 months
cardiovascular death, non-fatal myocardial infarction (MI), ischemic stroke, need for revascularization or , procedure-related complications (: pericardial effusion/cardiac tamponade, vascular complications and sustained ventricular arrhythmias).
1 secondary outcome
Efficacy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2013.
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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.
Pilar Jimenez-Quevedo, MD,PhD principal investigator
Hostpial Clinico San Carlos
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 Selected CD 133+ cells in people with Coronary Artery Disease and Refractory Angina, run by Pilar Jimenez Quevedo at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 6 Aug 2013. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
major adverse cardiac and cerebrovascular event (time frame: 6, 12 and 24 months). 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 6 Aug 2013.