NCT01660581

Intracardiac CD133+ Cells in Patients With No-option Resistant Angina

A Randomized,Prospective,Double-blind Study to Evaluate Intracardiac Injections of Bone Marrow,Autologous CD133+Cells(Electromechanical Mapping Based)in Patients With Resistant Angina and no Effective Revascularization Option. RegentVsel

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells in patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. Cells will be isolated from patients bone marrow and administered directly into the muscle of left ventricle. The main objective is to assess the treatments' influence on improvement of myocardial perfusion and function, and on decrease of occurrence of symptomatic angina.

Detailed description

Patients with a Stable angina pectoris (CCS II-IV) can potentially benefit from treatment with autological CD133+ cell populations, which include cells with a higher expression of cardiac and endothelial differentiation markers. REGENT VSEL Trial will include Patients with Angina resistant to pharmacological treatment and without the possibility of effective revascularization. The main objective of the study is to assess the treatments influence on: * improvement of myocardial perfusion * global and segmental contractility (LVEF) * occurrence of symptomatic angina * quality of life Regent Vsel is a prospective, randomized, double blind, placebo-controlled study with a planned number of 60 Patients. Randomization will be carried out according to a 1:1 mode. Every Patient will undergo a bone marrow aspiration. CD133+ cells will be isolated from bone marrow aspirates. Patients randomized to experimental group will receive isolated cells (direct left ventricular muscle administration). Patients enrolled to control group will get only a placebo solution injected into the muscle.

Conditions

• Stable Angina

Interventions

Type	Name	Description
BIOLOGICAL	intramyocardial injection (electromechanical mapping based)	Patient will undergo 3D electric and mechanical intracardiac mapping; based on maps generated intramyocardial administration of autologous CD133+ cells or placebo will be performed.
BIOLOGICAL	Placebo	Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-08-08
• Last updated: 2017-09-28

Locations

1 site across 1 country: Poland