Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis (PROGENITOR)

Tracking Information
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; (submitted: August 4, 2013)	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).
Original Primary Outcome Measures ICMJE; (submitted: June 9, 2008)	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; (submitted: August 4, 2013)	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)
Original Secondary Outcome Measures ICMJE; (submitted: June 9, 2008)	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
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Coronary Artery Disease; Refractory Angina
Intervention ICMJE	Biological: Selected CD 133+ cells; Endothelial progenitor cell CD 133
Study Arms	Active Comparator: selected CD133+cells Transendocardial injection of selected CD133+cells Intervention: Biological: Selected CD 133+ cells; No Intervention: no injection Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 4, 2013)	28
Original Estimated Enrollment ICMJE; (submitted: June 9, 2008)	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: 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 Exclusion Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Pilar Jimenez-Quevedo, MD,PhD Hostpial Clinico San Carlos
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