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Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial) (RECARDIO)

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ClinicalTrials.gov Identifier: NCT02059681
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Azienda Ospedaliera San Gerardo di Monza
Information provided by (Responsible Party):
Giulio Pompilio, Centro Cardiologico Monzino

Brief Summary:
The purpose of this study is to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment.

Condition or disease Intervention/treatment Phase
Chronic Myocardial Ischemia Other: Autologous bone marrow derived-CD133+ cells Phase 1

Detailed Description:

This will be a Phase I study investigating the safety and preliminary efficacy of endocavitary injection of bone-marrow-derived CD133+ cells in 15 patients with ischemic heart failure (IHF) not eligible for conventional revascularization. Patients eligible will undergo bone-marrow aspiration. On the day following bone-marrow aspiration patients will undergo fluoroscopy-based endocavitary intramyocardial injections of the target areas previously identified by gated-SPECT/CMR. CD133+ cells suspended in physiological saline supplemented with 5% human albumin solution will be injected into the myocardium via the endocardial route.

After discharge, efficacy follow-up will last 6-months safety follow-up (FU) will be extended up to 1 year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial)
Study Start Date : December 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: Autologous bone marrow derived-CD133+ cells
CD133+ cells (1-12x10^6) suspended in 10 ml physiological saline supplemented with 5% human albumin solution will be injected into the myocardium via the endocardial route; the whole 10 ml solution will be divided into 15-20 injections.
Other: Autologous bone marrow derived-CD133+ cells
Cell therapy




Primary Outcome Measures :
  1. Safety [ Time Frame: 1 year ]
    The primary objective of this study will be to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 6 months ]
    To determine the effects of autologous CD133+ cells as assessed before and 6-months after injection on a) regional myocardial perfusion on the basis of stress gated-SPECT and CMR when available; b) functional capacity on the basis of peak VO2 consumption at CPET.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ischemic heart failure not amenable to any type of revascularization procedure (percutaneous or surgical) as determined by one interventional cardiologist and one cardiovascular surgeon,
  2. Canadian Cardiovascular Society Angina functional class III to IV angina and/or symptoms of heart failure (NYHA score IIb to IV) under state-of-the-art maximal medical therapy,
  3. Left Ventricular Ejection Fraction between 20% and 45%,
  4. Peak V02 ≤ 21 mL/Kg/min,
  5. Presence of a reversible perfusion defect ≥ 10% of the left ventricular myocardium (at least 2 segments over 20) as determined by gated-SPECT, 6.18 years ≤ Age ≤ 75 years,

7.Hemodynamic stability, 8.Ability to accomplish a cardiopulmonary exercise testing, 9.Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before intervention and must be using oral or injectable contraception (non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start), 10.A signed consent form that has been approved by the institutional review board.

Exclusion Criteria:

  1. A high-risk acute coronary syndrome (ACS) or a myocardial infarction in the past 3 months,
  2. Presence of a documented unstable angina,
  3. Left ventricular thrombus, as documented by echocardiography,
  4. Evidence of a life-threatening arrhythmia,
  5. Presence of any severe mitral valve disease requiring valve replacement or reconstruction,
  6. Presence of a mechanical aortic valve,
  7. Presence of stenosis of the aortic valve, graded as ≥+2 equivalent to an orifice area of 1,5 cm2 or less,
  8. Presence of moderate to severe insufficiency of the aortic valve,
  9. A left ventricular wall thickness of <8 mm at the target site for cell injection, as assessed by 2-D echocardiography and/or cardiac MRI,
  10. Have a known, serious radiographic contrast allergy,
  11. Contraindications to bone-marrow aspiration,
  12. Be an organ transplant recipient,
  13. Have liver dysfunction, as evidenced by enzymes (AST,ALT) >3x the upper limits of normals,
  14. Severe renal failure (creatinine plasma levels > 2.5 mg/dl),
  15. A bleeding diathesis (defined as an INR greater than 1,5 not because of a reversible cause, i.e. warfarin),
  16. Have an hematologic abnormality without other explanation,
  17. Apparent infection (c-reactive protein (CPR)>30 mg/L, fever > 37 °C),
  18. An infectious-disease test result positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, treponema pallidum (VDRL), HTLV 1 and 2,
  19. Previous or current documented history of leukemia, myeloproliferative or myeloplastic disorders,
  20. Have a cardiac condition that limits lifespan to <1 y,
  21. A history of malignancy in the past 5 years,
  22. Have a history of drug or alcoholic abuse within the past 24 months,
  23. Be on chronic therapy with immunosuppressants,
  24. Pregnant or lactating status,
  25. Any condition that, in the judgment of the investigator, would place the patient at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059681


Contacts
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Contact: Giulio Pompilio, MD PhD +39 02 58002562 giulio.pompilio@ccfm.it
Contact: Beatrice Bassetti, MSc +39 02 58002027 beatrice.bassetti@ccfm.it

Locations
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Italy
Azienda Ospedaliera San Gerardo di Monza Recruiting
Monza, MB, Italy, 20900
Contact: Felice Achilli, MD         
Principal Investigator: Felice Achilli, MD         
Centro Cardiologico Monzino, IRCCS Recruiting
Milano, MI, Italy, 20138
Contact: Giulio Pompilio, MD PhD    +39 02 58002562    giulio.pompilio@ccfm.it   
Contact: Corrado Carbucicchio, MD    +39 02 58002616    corrado.carbucicchio@ccfm.it   
Principal Investigator: Giulio Pompilio, MD PhD         
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, TO, Italy, 10126
Contact: Sebastiano Marra, MD         
Principal Investigator: Sebastiano Marra, MD         
Sponsors and Collaborators
Centro Cardiologico Monzino
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Azienda Ospedaliera San Gerardo di Monza
Investigators
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Principal Investigator: Giulio Pompilio, MD PhD Centro Cardiologico Monzino, IRCCS

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giulio Pompilio, MD PhD, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT02059681     History of Changes
Other Study ID Numbers: S225/612
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Ischemia
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases