COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Cell Therapy In 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. Identifier: NCT00333827
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : March 13, 2017
Financiadora de Estudos e Projetos
Information provided by (Responsible Party):
Bernardo Rangel Tura, Ministry of Health, Brazil

Brief Summary:
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: optimal therapy for cardiaca failure Procedure: cell Phase 3

Detailed Description:

This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.

The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.

Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy
Study Start Date : January 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Active Comparator: Optimal Therapy
Optimal therapy for cardiac failure
Drug: optimal therapy for cardiaca failure
optimal therapy for cardiaca failure

Experimental: cell therapy
stem cell
Procedure: cell
stem cell

Primary Outcome Measures :
  1. increase of the ejection fraction of the left ventricle [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Death by any cause [ Time Frame: 1 year ]
  2. Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline [ Time Frame: 1 year ]
  3. Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire [ Time Frame: 6 month ]
  4. Difference in NYHA functional class [ Time Frame: 6 month ]
  5. Percent number of patients that reached an absolute increase of 5% in ejection fraction [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of dilated cardiomyopathy according to WHO criteria
  • Syndromic heart failure in functional class III or IV of the NYHA
  • Enrollment and continuous follow-up in cardiac out-patient clinic
  • Adequate medical therapy after optimization therapy
  • Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule

Exclusion Criteria:

  • Valvular diseases, except functional mitral or tricuspid reflow
  • Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
  • Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
  • Sustained ventricular tachycardia
  • Abusive use of alcohol or illicit drugs
  • Pregnancy
  • Use of cardio toxic drugs
  • Any co-morbidity with impact in life expectancy in 2 years
  • Renal function compromised (creatinine above 2 mg/dl)

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 identifier (NCT number): NCT00333827

Layout table for location information
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Brazil, 22.240-006
Sponsors and Collaborators
Ministry of Health, Brazil
Financiadora de Estudos e Projetos
Layout table for investigator information
Study Director: Antonio Carlos C de Carvalho, MD,PhD INCL
Study Chair: Bernardo R Tura, Md,MsC INCL
Principal Investigator: Augusto Z Bozza, MD INCL

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Bernardo Rangel Tura, Professor, Ministry of Health, Brazil Identifier: NCT00333827    
Other Study ID Numbers: EMRTCC-MCD
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Keywords provided by Bernardo Rangel Tura, Ministry of Health, Brazil:
Dilated Cardiomyopathy
stem cells
Randomized Controlled Trials
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases