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

Phase 2

Completed

• Conditions: Stable Angina
• Interventions: Biological: Placebo; Biological: intramyocardial injection (electromechanical mapping based)

• Registration Number: NCT01660581
• Lead Sponsor: Medical University of Silesia

Brief 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
2. Presence of ≥ 1 myocardial 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

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. Previous cardioverter-defibrillator or cardiac stimulator implantation
6. Allergy to contrast agents
7. History of malignancy
8. HIV, HBV, HCV infection
9. Life expectancy less than 6 months
10. Bleeding diathesis
11. Renal insufficiency (GFR < 30 mL/min/1.73m2)
12. Pregnancy, lactation, or ineffective contraception in women of childbearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	intramyocardial injection (electromechanical mapping based) of placebo - 0,9% NaCl plus 0,5% solution of patients' serum
CD133+	intramyocardial injection (electromechanical mapping based)	intramyocardial injection (electromechanical mapping based) of autological CD133+ cells, isolated from bone marrow

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion change	4 months after application of cell therapy	Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT)

Secondary Outcome Measures

Name	Time	Method
Occurrence of ventricular arrhythmia	1, 4, 6 and 12 months after application of cell therapy	24 hrs ECG monitoring
Exercise tolerance	4 and 12 months after application of cell therapy	Exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)
Global and segmental contractility change and myocardial perfusion change	MRI 4 months and echocardiography 4 and 12 months after application of cell therapy	Global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast
Occurrence of symptomatic angina	1, 4, 6 and 12 months after application of cell therapy	CCS, nitrates usage
Quality of life	1, 4, 6 and 12 months after application of cell therapy	Quality of life assessed by standard questionnaires: SF37, Seattle Angina
Occurrence of in-stent restenosis and progression of artherosclerotic lesions in remained coronary artery segments	4 months after application of cell therapy	Assessed by Intravascular Ultrasound (IVUS) and Optical coherence tomography (OCT) examination

Trial Locations

Locations (1)

Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca; 🇵🇱 Katowice-Ochojec, Silesian, Poland