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

NCT01660581 | Completed Phase 2

• 2 other identifiers: Regent Vsel2011-005435-98
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina

Keywords

CD133+; stem cells; Coronary Artery Disease; Stable Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Myocardial perfusion change

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

  4 months after application of cell therapy

Secondary Outcomes (6)

• Global and segmental contractility change and myocardial perfusion change

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

• Exercise tolerance

  4 and 12 months after application of cell therapy

• Occurrence of symptomatic angina

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

• Quality of life

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

• Occurrence of ventricular arrhythmia

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

Study Arms (2)

CD133+

EXPERIMENTAL

intramyocardial injection (electromechanical mapping based) of autological CD133+ cells, isolated from bone marrow

Biological: intramyocardial injection (electromechanical mapping based)

Placebo

PLACEBO COMPARATOR

intramyocardial injection (electromechanical mapping based) of placebo - 0,9% NaCl plus 0,5% solution of patients' serum

Biological: Placebo

Interventions

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.

CD133+

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

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

Katowice-Ochojec, Silesian, 40-635, Poland

Location

Related Publications (7)

• 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.

  PMID: 17533201 BACKGROUND

• 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.

  PMID: 17964040 BACKGROUND

• 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.

  PMID: 16267071 BACKGROUND

• 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.

  PMID: 15533859 BACKGROUND

• 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.

  PMID: 19454638 BACKGROUND

• 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.

  PMID: 17951319 BACKGROUND

• 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.

  PMID: 27903568 DERIVED

MeSH Terms

Conditions

Angina, Stable; Macular Dystrophy, Retinal, 2; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Wojciech Wojakowski, MD, PhD

  Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach Górnośląskie Centrum Medyczne III Klinika Kardiologii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

PL (1)