A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. REGENT-VSEL Study. - REGENT VSE

Phase 1

• Conditions: Stable angina pectoris CCS II-IV; MedDRA version: 14.1Level: LLTClassification code 10049194Term: Stable angina pectorisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005435-98-PL
• Lead Sponsor: Slaski Uniwersytet Medyczny w Katowicach

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-24
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
2.Presence of = 1 miocardium segment with ischemia features in Tc-99m SPECT
3.Patients disqualified from revascularization procedures by heart-team
4.Patient age > 18 and < 75 year old
5.Patient must provide written informed consent for participation in study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.acute coronary syndrome in less than 6 months prior to enrollment
2.heart failure NYHA III-IV
3.LVEF<35%
4.presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
5.status after cardioverter defibrillator or cardiac stimulator implantation
6.allergy to contrast agents
7.malignancy in medical interview
8.HIV, HBV, HCV infection
9.status associated with life expectancy less than 6 months
10.bleeding diathesis
11.renal insufficiency (GFR < 30 mL/min/1.73m2)
12.pregnancy, lactation, or lack of effective contraception in women of childbearing age

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.Assessment of influence of direct administration of isolated from bone marrow, autological CD133+ cells on improvement of myocardial perfusion and function and decrease of occurrence of symptomatic angina of patients with angina resistant to pharmacological treatment without possibility of effective revascularization<br>2.Assessment of therapy safety <br>;Secondary Objective: ;Primary end point(s): Myocardial perfusion change assessed by perfusion scintigraphy<br>(99mTc SPECT) 4 months after application of cell therapy<br>;Timepoint(s) of evaluation of this end point: 4 months after application of cell therapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast<br><br>2.exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)<br><br>3.occurrence of symptomatic angina (CCS, nitrates usage)<br>4.quality of life assessed by standard questionnaires (SF37, Seattle Angina)<br>;Timepoint(s) of evaluation of this end point: 1. 4 months after application of cell therapy<br>2. 4 and 6 months after application of cell therapy<br>3. 1, 4, 6 and 12 months after application of cell therapy<br>4. 1, 4, 6 and 12 months after application of cell therapy<br>