Intracardiac CD133+ Cells in Patients With No-option Resistant Angina (Regent Vsel)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Medical University of Silesia
Sponsor:
Information provided by (Responsible Party):
Wojciech Wojakowski MD, PhD, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT01660581
First received: August 6, 2012
Last updated: February 12, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Stable Angina
Biological: intramyocardial injection (electromechanical mapping based)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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. Regent Vsel Study.

Resource links provided by NLM:


Further study details as provided by Medical University of Silesia:

Primary Outcome Measures:
  • Myocardial perfusion change [ Time Frame: 4 months after application of cell therapy ] [ Designated as safety issue: No ]
    Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT)


Secondary Outcome Measures:
  • Global and segmental contractility change and myocardial perfusion change [ Time Frame: MRI 4 months and echocardiography 4 and 12 months after application of cell therapy ] [ Designated as safety issue: No ]
    Global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast

  • Exercise tolerance [ Time Frame: 4 and 12 months after application of cell therapy ] [ Designated as safety issue: No ]
    Exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)

  • Occurrence of symptomatic angina [ Time Frame: 1, 4, 6 and 12 months after application of cell therapy ] [ Designated as safety issue: Yes ]
    CCS, nitrates usage

  • Quality of life [ Time Frame: 1, 4, 6 and 12 months after application of cell therapy ] [ Designated as safety issue: No ]
    Quality of life assessed by standard questionnaires: SF37, Seattle Angina

  • Occurrence of ventricular arrhythmia [ Time Frame: 1, 4, 6 and 12 months after application of cell therapy ] [ Designated as safety issue: Yes ]
    24 hrs ECG monitoring

  • Occurrence of in-stent restenosis and progression of artherosclerotic lesions in remained coronary artery segments [ Time Frame: 4 months after application of cell therapy ] [ Designated as safety issue: Yes ]
    Assessed by Intravascular Ultrasound (IVUS) and Optical coherence tomography (OCT) examination


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD133+
intramyocardial injection (electromechanical mapping based) of autological CD133+ cells, isolated from bone marrow
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.
Placebo Comparator: Placebo
intramyocardial injection (electromechanical mapping based) of placebo - 0,9% NaCl plus 0,5% solution of patients' serum
Biological: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660581

Contacts
Contact: Wojciech Wojakowski, MD, PhD +48 32 2523930 wojtek.wojakowski@gmail.com

Locations
Poland
Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Recruiting
Katowice-Ochojec, Silesian, Poland, 40-635
Contact: Wojciech Wojakowski, MD, PhD    +48 32 2523930    wojtek.wojakowski@gmail.com   
Principal Investigator: Wojciech Wojakowski, MD, PhD         
Sponsors and Collaborators
Medical University of Silesia
Investigators
Principal Investigator: Wojciech Wojakowski, MD, PhD Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne III Klinika Kardiologii
  More Information

Publications:

Responsible Party: Wojciech Wojakowski MD, PhD, MD, PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT01660581     History of Changes
Other Study ID Numbers: Regent Vsel, 2011-005435-98
Study First Received: August 6, 2012
Last Updated: February 12, 2014
Health Authority: Poland: Komisja Bioetyczna Slaski Uniwersytet Medyczny
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Medical University of Silesia:
CD133+
stem cells
Coronary Artery Disease
Stable Angina Pectoris

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014