Clinical trial to evaluate the efficacy of intracoronary infusion of autologous bone marrow mononuclear in patients with dilated cardiomyopathy

Phase 1

• Conditions: dilated cardiomyopathy; MedDRA version: 14.1Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002015-98-ES
• Lead Sponsor: Fundación Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-12
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Patients with dilated cardiomiophaty

2. Minimal evolution from the diagnosis of 6 months

3.Absence of coronary injuries.

4.Patients with pharmacological stable treatment for at least 6 months prior to enrollment.

5.FEVI <40 % or FEVI 40 %-50 % if VTDVI> 110 ml/m2.

6.Presence sinus rhythm.

7.Patients who have given they informed consent for participation in the clinical trial.

8.The women of childbearing potential must have a negative pregnancy test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

Exclusion Criteria

1. Dilated cardiomyopathy of toxic origin, or ischemic diseases.
2. Recent history of myocarditis.
3. Patients suceptible of treatment with resynchronization
4. Patients in active waiting-list of cardiac Transplant
5. Coexistence of other systemic serious diseases.
6. Coexistence of any type of hematologic disease.
7. Pregnant women, Breast-Feeding, or in fertile age that they are not using a contraceptive effective method.
8. Patients with malignant or pre-malignant tumors.
9. Positive serology for HBV, HCV or HIV.
10. Patients who at the time of inclusion in the trial are taking any medications prohibited by the protocol. We define a washout period of two months in order to be included in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified