Efecto de la Infusión Intracoronaria de Células Progenitoras de Médula Ósea sobre la Regeneración Miocárdica en Pacientes con Miocardiopatía Dilatada. Estudio Cínico-Biológico. Effects of intracoronary infusion of bone marrow-derived progenitor cells on myocardial regeneration in patients with non-ischemic dilated cardiomyophathy. A clinico-biological study

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-003088-36-ES
• Date of registration: 11/09/2007
• Prospective Registration: Yes
• Primary sponsor: AININCAR
• Public title: Efecto de la Infusión Intracoronaria de Células Progenitoras de Médula Ósea sobre la Regeneración Miocárdica en Pacientes con Miocardiopatía Dilatada. Estudio Cínico-Biológico. Effects of intracoronary infusion of bone marrow-derived progenitor cells on myocardial regeneration in patients with non-ischemic dilated cardiomyophathy. A clinico-biological study
• Scientific title: Efecto de la Infusión Intracoronaria de Células Progenitoras de Médula Ósea sobre la Regeneración Miocárdica en Pacientes con Miocardiopatía Dilatada. Estudio Cínico-Biológico. Effects of intracoronary infusion of bone marrow-derived progenitor cells on myocardial regeneration in patients with non-ischemic dilated cardiomyophathy. A clinico-biological study
• Date of first enrolment: 15/02/2008
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003088-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1) Patients diagnosed of established of Idiopathic Dilated Cardiomyopathy
2) Left ventricular ejection fraction< 50%
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Dilated Cardiomyopathy of alcoholic or toxic origin
2) Patients older than 80 years
3) Miocarditis
4) Need for resinchronization
5) Being included in the waiting list for heart transplant
6) Pregnancy
7) Patients with any hematological disease
8) Patients with any other systemic disorder
9) Patients with any malignant or premalignat disease


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Miocardiopatía dilatada de origen idiopático Idiopathic Dilated Cardiomyopathy
MedDRA version: 9.1 Level: LLT Classification code 10059868 Term: Non-ischemic dilated cardiomyopathy

Intervention(s)

Product Name: Bone marrow mononuclear cells
Product Code: BMMNC
Pharmaceutical Form: Injection*

Primary Outcome(s)

Primary end point(s): 1) Improvement of the Left Ventricular function at the follow-up (6 months and 12 months) measured by angiography, magnetic nuclear resonance, echocardiography and treadmill direct oxygen comsumption
2) Improvement of the NYHA functional grade and quality of life

Main Objective: The main aim of the trial is to determine whether the intracoronary infusion of autologous bone marrow-derived stem cells is associated with improved ventricular function in patients with idiopathic dilated cardiomyopathy

Secondary Objective: We will try to correlate the level of the improvement in ventricular function with the cell content and the biological characteristics of the infused marrow.

Secondary ID(s)

TCMR0007/06