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.

• Status: Terminated
• Trial end date: 2020-04-21
• Target enrollment: 0
• Participant gender: All

Summary

Clinical trial phase IIb, double-blind, randomized, controlled with placebo. There is sufficient preliminary evidence to consider intracoronary injection of bone marrow progenitor cells as a viable, safe and beneficial treatment in patients with dilated cardiomyopathy, although the biological mechanism of action of bone marrow cells in the myocardium is not known. In this project we propose to investigate comparatively and from a biological and clinical point of view the applicability of regenerative therapy with autologous bone marrow cells in patients with dilated cardiomyopathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborator: Iniciativa Andaluza en Terapias Avanzadas

Criteria

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.