MedTrace Logo

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

NCT01660581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-09-28

No results posted yet for this study

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.

Conditions

  • Stable Angina

Interventions

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.

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Principal Investigators

  • Wojciech Wojakowski, MD, PhD · Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne III Klinika Kardiologii

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Poland

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660581 on ClinicalTrials.gov