Last updated on March 2018

Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Idiopathic Dilated Cardiomyopathy
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Patients of both sexes and ages between 18 and 70 years.
  2. Patients diagnosed with dilated cardiomyopathy established by echocardiography.
  3. Minimum evolution since diagnosis of 6 months.
  4. Absence of coronary injury tested with multislice CT and/or hemodynamic study performed after study entry, or within the previous 36 months (or before in specific low risk clinical profiles) if no angina symptomatology is present.
  5. Patients receiving optimized medical therapy for at least 6 months prior to enrollment (individually adjusted according to functional status).
  6. Ejection fraction of the left ventricle <40% or ejection fraction of the left ventricle 40% -50% if left ventricular tele-diastolic volume is > 110 ml/m2.
  7. Presence of sinus rhythm.
  8. Writen informed consent for participation in the trial.
  9. Normal laboratory parameters, defined by: Leukocytes 3000; Neutrophils 1500; Platelets 100,000; Aspartate aminotransferase / Alanine aminotransferase 2.5 standard range institution; Creatinine 2.5 mg / dL; Haemoglobin > 9 g/dL
  10. Women of childbearing potential must have negative results on a pregnancy test and agree to use medically approved methods of contraception thoughout follow up.

Exclusion Criteria:

  1. Secondary Dilated cardiomyopathy.
  2. Recent history of myocarditis (< 6 months prior to study entry).
  3. Patients amenable to receive cardiac resynchronization therapy
  4. Patients in active waiting list for heart transplantation.
  5. Coexistence of other serious systemic diseases.
  6. Coexistence of any type of blood disease
  7. Pregnant or breastfeeding women; or women of childbearing potential not comminting to use effective contraception.
  8. Patients who are currently participating, or have completed their participation in a clinical trial within the last 3 months. Patients who have participated in any advanced therapies clinical trial any time previously.
  9. Patients with malignant or pre-malignant tumors.
  10. Positive serology for hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
  11. Use of any protocolo prohibited medication. A wash-out period of 2 months can be considered for inclusion in the trial.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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