Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 160 for:    Idiopathic Dilated Cardiomyopathy

Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957826
Recruitment Status : Unknown
Verified November 2016 by Hospital General Universitario Gregorio Marañon.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : November 18, 2016
Sponsor:
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon

Tracking Information
First Submitted Date  ICMJE December 21, 2012
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • Major adverse cardiac adverse events. SAEs and AEs. [ Time Frame: change from enrollment( 1, 3, 6, 12, 18 and 24 months) ]
    Major adverse cardiac adverse events includes cerebral adverse events
  • NYHA functional class. [ Time Frame: Change from enrolment( 1, 3, 6, 12, 18, 24 months) ]
  • Incidence of complications with the use of NOGA XPTM catheters. [ Time Frame: Change from enrolment( 1, 3, 6, 12, 18, 24 months) ]
  • Laboratory parameters including C-reactive protein an brain natriuretic peptide [ Time Frame: Change from enrolment( 1, 3, 6, 12, 18, 24 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01957826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • NYHA Functional Class [ Time Frame: 1, 3, 6, 12, 18, 24 months ]
  • Max.oxygen consumption(MVO2),functional capacity. [ Time Frame: 6,12,24 months ]
  • Quality of life questionnaires [ Time Frame: 6,12 and 24 months ]
    include 36-item Short Form Survey(SF 36) and Minnesota Living UIT Heart Failure questionnaire
  • Extension. of perfusion defects(MRI/SPECT). [ Time Frame: 6 and 24 months ]
  • LVEF, ventricular vol.,wall motion score index(echocard./MRI/SPECT [ Time Frame: 6,12 and 24 months ]
  • LVEF(left ventriculogram, electromech. mapping parameters(NOGA XPTM)) [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy
Official Title  ICMJE Phase I/II Randomized Clinical Trial to Assess the Safety and Feasibility of Transendocardial Injection of Bone Marrow Autologous Mesenchymal Stem Cells in Patients With Idiopathic Dilated Cardiomyopathy.
Brief Summary The purpose of this study is to assess the safety, the feasibility and the efficacy of transendocardial injection of bone marrow-derived mesenchymal stem cells (MSCs) in patients with dilated idiopathic cardiomyopathy.
Detailed Description

Chronic congestive heart failure (CHF) is a public health problem that entails high rates of morbidity and mortality, and enormous costs for health systems worldwide. In the United States there are 5 million people living with CHF, and each year 60.000 people reach terminal phases of the disease, with mortality rates of 70-80% at two years. Although the first cause of CHF in developed countries is atherosclerotic coronary artery disease (CAD), dilated idiopathic cardiomyopathy (DCM) represents almost half of the cases of newly diagnosed CHF. Treatment of CHF includes pharmacological and non-pharmacological strategies, including implantable cardioverter defibrillators, cardiac resynchronization therapy and heart transplantation. Despite all these advances, CHF prognosis remains poor. Cardiac stem cell therapy emerged more than ten years ago as a new hope for CHF patients.

Although the most extensive evidence of the benefits of stem cell therapy for cardiovascular diseases refers to ischemic heart disease (CAD), initial experiences with stem cells for other conditions such as DCM are encouraging.

This randomized clinical trial will include 70 patients with DCM, left ventricular ejection fraction (LVEF) between 20% and 45%, and who are symptomatic in New York Heart Association (NYHA) functional class II-III/IV. In a first-in-man pilot phase, 10 patients will be treated with transendocardial injections of bone marrow-derived MSCs after cardiac catheterization and NOGA XPTM mapping of the left ventricle. A Data and Safety Monitoring Board (DSMB) will analyse the safety and feasibility of this first phase of the trial, and then 60 patients more will be randomized to receive MSCs or placebo (ratio 3:1).

Primary objectives include safety and feasibility variables, and secondary objectives include efficacy variables. All patients will be studied with a complete cardiac imaging protocol that includes: electrocardiography, echocardiography, treadmill tests with oxygen consumption, holter, laboratory analyses, magnetic resonance imaging (MRI), single photon emission computed tomography (SPECT), electromechanical mapping (NOGA XPTM) and quality of life questionnaires.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Idiopathic Dilated Cardiomyopathy
Intervention  ICMJE
  • Other: bone marrow-derived MSCs injection
    transendocardial injection of 30-40 million bone marrow-derived MSCs with the NOGA XPTM platform. 15 injections in the anterior wall of the left ventricle.
  • Other: placebo intervention
    placebo administration
Study Arms  ICMJE
  • Placebo Comparator: placebo comparator
    transendocardial injection of placebo solution
    Intervention: Other: placebo intervention
  • Experimental: bone marrow-derived MSCs injection
    transendocardial injection of 30-40 million bone marrow-derived MSCs with the NOGA XPTM platform. 15 injections in the anterior wall of the left ventricle.
    Intervention: Other: bone marrow-derived MSCs injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • II-III NYHA functional class, under optimal medical therapy.
  • LVEF ≥ 20% and ≤ 45% by echocardiography, SPECT or left ventriculogram one month prior to enrollment.
  • Anterior wall thickness ≥ 8 mm by echocardiography or MRI one month prior to enrollment.
  • Idiopathic DCM diagnosis (having excluded CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases) six months prior to enrollment.
  • Patients rejected for heart transplantation should have been discussed in the Heart Team at their respective centres, and a document stating the reason for exclusion will be kept in the medical record.
  • Able to exercise on a treadmill, MVO2 between ≥ 12 and ≤ 21 ml/Kg/min.
  • Hemodynamic stability (blood pressure > 100/40 mmHg, heart rate < 110 bpm and oxygen saturation > 95%).
  • Negative pregnancy test in women.
  • Signed informed consent

Exclusion Criteria:

  • Evidence of secondary dilated cardiomyopathy causes: CAD, valvular heart disease, cardiac toxic drugs, tachyarrhythmias, metabolic diseases, systemic diseases, infectious diseases, myocarditis or postpartum ventricular dysfunction.
  • Permanent atrial fibrillation.
  • Candidates for ICD or CRT devices. Patients with theses devices can be enrolled if the device has been implanted at least 6 months before inclusion, and only if no-response has been observed to CRT.
  • Candidates for heart transplantation if surgery is anticipated in the next 2 years.
  • Left ventricular thrombus by echocardiography, MRI or left ventriculogram.
  • Peripheral artery disease that precludes cardiac catheterization with 8 Fr sheaths. .
  • Anterior wall thickness < 8 mm by echocardiography or MRI one month prior to enrollment.
  • Chronic renal failure (creatinine > 2,5 mg/dL).
  • I or IV NYHA functional class. Cardiogenic shock is defined as systolic blood pressure < 90 mmHg with no response to fluids, or < 100 mmHg with inotropes and without bradycardia.
  • Previous history of drug abuse (alcohol, etc…).
  • Acute or chronic infectious disease (including B/C hepatitis and HIV).
  • Pregnancy or child-bearing period.
  • MRI contraindications: pacemakers, ICD, metalic prosthesis, etc.
  • Bleeding or coagulation disorders (INR > 2 without anticoagulation treatment).
  • Cancer history 5 years prior to enrollment.
  • Life expectancy less than 1 year.
  • Any disease or condition that the investigator finds decisive for exclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01957826
Other Study ID Numbers  ICMJE FIBHGM-ECNC017-2010
2010-024406-35 ( EudraCT Number )
MIYOCYTE ( Other Identifier: MYOCYTE )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital General Universitario Gregorio Marañon
Study Sponsor  ICMJE Hospital General Universitario Gregorio Marañon
Collaborators  ICMJE Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators  ICMJE
Study Chair: Francisco Fernandez Aviles, PhD Hospital General Universitario Gregorio Marañón
PRS Account Hospital General Universitario Gregorio Marañon
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP