Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis (PROGENITOR)
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ClinicalTrials.gov Identifier: NCT00694642 |
Recruitment Status
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Completed
First Posted
: June 10, 2008
Last Update Posted
: August 6, 2013
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Sponsor:
Pilar Jimenez Quevedo
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Pilar Jimenez Quevedo, Hospital San Carlos, Madrid
Tracking Information | ||||
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First Submitted Date ICMJE | June 5, 2008 | |||
First Posted Date ICMJE | June 10, 2008 | |||
Last Update Posted Date | August 6, 2013 | |||
Study Start Date ICMJE | May 2008 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE |
Major adverse events [ Time Frame: 6, 12 and 24 months ] | |||
Change History | Complete list of historical versions of study NCT00694642 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Efficacy [ Time Frame: 6 months ] 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)
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Original Secondary Outcome Measures ICMJE |
The change in the myocardial perfusion defect at baseline versus follow-up measured by Magnetic Resonance and Single Photon Emission Computed Tomography (SPECT) [ Time Frame: 6, 12 and 24 months ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis | |||
Official Title ICMJE | Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis | |||
Brief 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: Selected CD 133+ cells
Endothelial progenitor cell CD 133 |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
28 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date | February 2012 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00694642 | |||
Other Study ID Numbers ICMJE | progenitorCD133 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pilar Jimenez Quevedo, Hospital San Carlos, Madrid | |||
Study Sponsor ICMJE | Pilar Jimenez Quevedo | |||
Collaborators ICMJE | Fundación Mutua Madrileña | |||
Investigators ICMJE |
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PRS Account | Hospital San Carlos, Madrid | |||
Verification Date | May 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |