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Stable AnginaPhase 2RegentVselNCT01660581

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

A Phase 2 study testing intramyocardial injection (electromechanical mapping based) in people with Stable Angina, run by Medical University of Silesia at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stable Angina
What is being tested?
intramyocardial injection (electromechanical mapping based)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 sitePoland
Study dates
Jun 2012to Sep 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Acute coronary syndrome in less than 6 months prior to enrollment
  • Heart failure NYHA III-IV
  • LVEF <35%
  • Presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
  • Previous cardioverter-defibrillator or cardiac stimulator implantation
  • Allergy to contrast agents
Show all 12Show fewer
  • History of malignancy
  • HIV, HBV, HCV infection
  • Life expectancy less than 6 months
  • Bleeding diathesis
  • Renal insufficiency (GFR < 30 mL/min/1.73m2)
  • Pregnancy, lactation, or ineffective contraception in women of childbearing potential

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

    Katowice-Ochojec, Silesian, 40-635

Other trials in Poland

About this study

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. RegentVsel

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.

Read the 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
Being tested
intramyocardial injection (electromechanical mapping based), Placebo
Keywords
CD133+, stem cells, Coronary Artery Disease, Stable Angina Pectoris
Medical subject headings
Angina, Stable, Macular Dystrophy, Retinal, 2, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intramyocardial injection (electromechanical mapping based)Biological

    Patient will undergo 3D electric and mechanical intracardiac mapping; based on maps generated intramyocardial administration of autologous CD133+ cells or placebo will be performed.

  • PlaceboBiological

    Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.

Study groups in NCT01660581
Study groupRoleWhat they receive
CD133+Experimentalintramyocardial injection (electromechanical mapping based) of autological CD133+ cells, isolated from bone marrow
Receives: Biological: intramyocardial injection (electromechanical mapping based)
PlaceboPlacebo comparatorintramyocardial injection (electromechanical mapping based) of placebo - 0,9% NaCl plus 0,5% solution of patients' serum
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial perfusion change

    Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT)

    Measured: 4 months after application of cell therapy

Secondary outcomes (6)

  1. Global and segmental contractility change and myocardial perfusion change

    Global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast

    Measured: MRI 4 months and echocardiography 4 and 12 months after application of cell therapy

  2. Exercise tolerance

    Exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)

    Measured: 4 and 12 months after application of cell therapy

  3. Occurrence of symptomatic angina

    CCS, nitrates usage

    Measured: 1, 4, 6 and 12 months after application of cell therapy

  4. Quality of life

    Quality of life assessed by standard questionnaires: SF37, Seattle Angina

    Measured: 1, 4, 6 and 12 months after application of cell therapy

  5. Occurrence of ventricular arrhythmia

    24 hrs ECG monitoring

    Measured: 1, 4, 6 and 12 months after application of cell therapy

  6. Occurrence of in-stent restenosis and progression of artherosclerotic lesions in remained coronary artery segments

    Assessed by Intravascular Ultrasound (IVUS) and Optical coherence tomography (OCT) examination

    Measured: 4 months after application of cell therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01660581
Sponsor's protocol ID
Regent Vsel
Other IDs
2011-005435-98
Acronym
RegentVsel
Status last verified
Sep 2017
First submitted
6 Aug 2012
Last updated
28 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Abdel-Latif A, Bolli R, Tleyjeh IM, Montori VM, Perin EC, Hornung CA, Zuba-Surma EK, Al-Mallah M, Dawn B. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. doi: 10.1001/archinte.167.10.989.

    PubMed 17533201

  • Lipinski MJ, Biondi-Zoccai GG, Abbate A, Khianey R, Sheiban I, Bartunek J, Vanderheyden M, Kim HS, Kang HJ, Strauer BE, Vetrovec GW. Impact of intracoronary cell therapy on left ventricular function in the setting of acute myocardial infarction: a collaborative systematic review and meta-analysis of controlled clinical trials. J Am Coll Cardiol. 2007 Oct 30;50(18):1761-7. doi: 10.1016/j.jacc.2007.07.041. Epub 2007 Oct 15.

    PubMed 17964040

  • Wojakowski W, Tendera M, Zebzda A, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Krol M, Ochala A, Kozakiewicz K, Ratajczak MZ. Mobilization of CD34(+), CD117(+), CXCR4(+), c-met(+) stem cells is correlated with left ventricular ejection fraction and plasma NT-proBNP levels in patients with acute myocardial infarction. Eur Heart J. 2006 Feb;27(3):283-9. doi: 10.1093/eurheartj/ehi628. Epub 2005 Nov 2.

    PubMed 16267071

  • Wojakowski W, Tendera M, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Ochala A, Ratajczak MZ. Mobilization of CD34/CXCR4+, CD34/CD117+, c-met+ stem cells, and mononuclear cells expressing early cardiac, muscle, and endothelial markers into peripheral blood in patients with acute myocardial infarction. Circulation. 2004 Nov 16;110(20):3213-20. doi: 10.1161/01.CIR.0000147609.39780.02. Epub 2004 Nov 8.

    PubMed 15533859

  • van Ramshorst J, Bax JJ, Beeres SL, Dibbets-Schneider P, Roes SD, Stokkel MP, de Roos A, Fibbe WE, Zwaginga JJ, Boersma E, Schalij MJ, Atsma DE. Intramyocardial bone marrow cell injection for chronic myocardial ischemia: a randomized controlled trial. JAMA. 2009 May 20;301(19):1997-2004. doi: 10.1001/jama.2009.685.

    PubMed 19454638

  • Dimmeler S, Burchfield J, Zeiher AM. Cell-based therapy of myocardial infarction. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):208-16. doi: 10.1161/ATVBAHA.107.155317. Epub 2007 Oct 19.

    PubMed 17951319

  • Wojakowski W, Jadczyk T, Michalewska-Wludarczyk A, Parma Z, Markiewicz M, Rychlik W, Kostkiewicz M, Gruszczynska K, Blach A, Dzier Zak-Mietla M, Wanha W, Ciosek J, Ochala B, Rzeszutko L, Cybulski W, Partyka L, Zasada W, Wludarczyk W, Dworowy S, Kuczmik W, Smolka G, Pawlowski T, Ochala A, Tendera M. Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial. Circ Res. 2017 Feb 17;120(4):670-680. doi: 10.1161/CIRCRESAHA.116.309009. Epub 2016 Nov 30.

    PubMed 27903568

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intramyocardial injection (electromechanical mapping based) in people with Stable Angina, run by Medical University of Silesia at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial perfusion change (time frame: 4 months after application of cell therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01660581, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.

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