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

Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694642

Acronym

PROGENITOR

Enrollment

Registered

2008-06-10

Start date

2008-05-31

Completion date

2012-02-29

Last updated

2013-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Refractory Angina

Keywords

Refractory angina

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.

Interventions

BIOLOGICALSelected CD 133+ cells

Endothelial progenitor cell CD 133

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
major adverse cardiac and cerebrovascular event	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).

Secondary

Measure	Time frame	Description
Efficacy	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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026