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

Primary Purpose

Coronary Artery Disease, Refractory Angina

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Selected CD 133+ cells
Sponsored by
Pilar Jimenez Quevedo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Refractory angina

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

selected CD133+cells

no injection

Arm Description

Transendocardial injection of selected CD133+cells

Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

First Posted
June 5, 2008
Last Updated
August 4, 2013
Sponsor
Pilar Jimenez Quevedo
Collaborators
Fundación Mutua Madrileña
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1. Study Identification

Unique Protocol Identification Number
NCT00694642
Brief Title
Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
Acronym
PROGENITOR
Official Title
Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pilar Jimenez Quevedo
Collaborators
Fundación Mutua Madrileña

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Refractory Angina
Keywords
Refractory angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
selected CD133+cells
Arm Type
Active Comparator
Arm Description
Transendocardial injection of selected CD133+cells
Arm Title
no injection
Arm Type
No Intervention
Arm Description
Boths groups were treated with G-CSF, underwent an apheresis and NOGA mapping
Intervention Type
Biological
Intervention Name(s)
Selected CD 133+ cells
Intervention Description
Endothelial progenitor cell CD 133
Primary Outcome Measure Information:
Title
major adverse cardiac and cerebrovascular event
Description
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).
Time Frame
6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Efficacy
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Jimenez-Quevedo, MD,PhD
Organizational Affiliation
Hostpial Clinico San Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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

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