Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
PROGENITOR
Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 coronary-artery-disease
Started May 2008
Typical duration for phase_1 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedAugust 6, 2013
May 1, 2008
1 year
June 5, 2008
August 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
6, 12 and 24 months
Secondary Outcomes (1)
Efficacy
6 months
Study Arms (2)
selected CD133+cells
ACTIVE COMPARATORTransendocardial injection of selected CD133+cells
no injection
NO INTERVENTIONBoths groups were treated with G-CSF, underwent an apheresis and NOGA mapping
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pilar Jimenez Quevedolead
- Fundación Mutua Madrileñacollaborator
Study Sites (1)
Hospital Clinico San Carlos
Madrid, Madrid, 28040, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pilar Jimenez-Quevedo, MD,PhD
Hostpial Clinico San Carlos
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 10, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2009
Study Completion
February 1, 2012
Last Updated
August 6, 2013
Record last verified: 2008-05