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.

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.

Conditions

• Idiopathic Dilated Cardiomyopathy

Interventions

DRUG

Infusion of autologous mononuclear bone marrow cells

Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)

DRUG

Placebo infusion

Placebo infusion plus conventional medical treatment (as indicated by clinician)

Sponsors & Collaborators

• Iniciativa Andaluza en Terapias Avanzadas

  collaborator OTHER

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

  lead OTHER

Principal Investigators

• Miguel Romero Moreno, MD, PhD · Hospital Universitario Reina Sofía

• Manuel Sobrino Marquez, MD · Hospitales Universitarios Virgen del Rocío

• Luis A Iñigo García, MD · Hospital Costa del Sol

• Ricardo Zayas Rueda, MD · Hospital Universitario Puerta del Mar

• Manuel De Mora Martín, MD, PhD · Hospital Regional U. Carlos Haya

• Silvia López Fernández, MD · University Hospital Virgen de las Nieves

• José Francisco Díaz Fernández, MD · Hospital Universitario Juan Ramón Jimenez

• Jesús Oneto Otero, MD · Hospital de Jerez

• Rafael Ruiz Salmerón, MD · Hospital Universitario Virgen Macarena

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-06

Primary Completion

2018-10-19

Completion

2020-04-21

Countries

• Spain

Study Locations