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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease Refractory Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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selected CD133+cells

Transendocardial injection of selected CD133+cells

Group Type ACTIVE_COMPARATOR

Selected CD 133+ cells

Intervention Type BIOLOGICAL

Endothelial progenitor cell CD 133

no injection

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Selected CD 133+ cells

Endothelial progenitor cell CD 133

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No