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.

NCT02033278 | Terminated Phase 2 DMC

• 1 other identifier: CMMo/MD/2013
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in ventricular function measured angiographically.

  24 months

Secondary Outcomes (5)

• Degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up.

  24 months

• Clinical and analytical progress (NYHA grade & BNP)

  24 months

• Time of evolution since diagnosis of idiopathic dilated cardiomyopathy prior to study entry.

  24 months

• Functional recovery as measured with ergometry

  24 months

• Echocardiography and Electrocardiography variables

  24 months

Study Arms (2)

Infusion of autologous mononuclear bone marrow cells

EXPERIMENTAL

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

Drug: Infusion of autologous mononuclear bone marrow cells

Placebo infusion

PLACEBO COMPARATOR

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

Drug: Placebo infusion

Interventions

Infusion of autologous mononuclear bone marrow cells DRUG

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

Infusion of autologous mononuclear bone marrow cells

Placebo infusion DRUG

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

Placebo infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes and ages between 18 and 70 years.
• Patients diagnosed with dilated cardiomyopathy established by echocardiography.
• Minimum evolution since diagnosis of 6 months.
• 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.
• Patients receiving optimized medical therapy for at least 6 months prior to enrollment (individually adjusted according to functional status).
• 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.
• Presence of sinus rhythm.
• Writen informed consent for participation in the trial.
• 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
• Women of childbearing potential must have negative results on a pregnancy test and agree to use medically approved methods of contraception thoughout follow up.

You may not qualify if:

• Secondary Dilated cardiomyopathy.
• Recent history of myocarditis (\< 6 months prior to study entry).
• Patients amenable to receive cardiac resynchronization therapy
• Patients in active waiting list for heart transplantation.
• Coexistence of other serious systemic diseases.
• Coexistence of any type of blood disease
• Pregnant or breastfeeding women; or women of childbearing potential not comminting to use effective contraception.
• 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.
• Patients with malignant or pre-malignant tumors.
• Positive serology for hepatitis B virus, hepatitis C virus or human immunodeficiency virus.

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (9)

Hospital Universitario Puerta del Mar

Cadiz, Spain

Location

Hopistal Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital Universitario Juan Ramón Jimenez

Huelva, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Spain

Location

Hospital Costa del Sol

Marbella, Spain

Location

Hospital Regional U. Carlos Haya

Málaga, 29014, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Related Publications (1)

• Romero M, Suarez-de-Lezo J, Herrera C, Pan M, Lopez-Aguilera J, Suarez-de-Lezo J Jr, Baeza-Garzon F, Hidalgo-Lesmes FJ, Fernandez-Lopez O, Martinez-Atienza J, Cebrian E, Martin-Palanco V, Jimenez-Moreno R, Gutierrez-Fernandez R, Nogueras S, Carmona MD, Ojeda S, Cuende N, Mata R. Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol. BMC Cardiovasc Disord. 2019 Aug 22;19(1):203. doi: 10.1186/s12872-019-1182-4.

  PMID: 31438858 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Miguel Romero Moreno, MD, PhD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

• Manuel Sobrino Marquez, MD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Luis A Iñigo García, MD

  Hospital Costa del Sol

  PRINCIPAL INVESTIGATOR

• Ricardo Zayas Rueda, MD

  Hospital Universitario Puerta del Mar

  PRINCIPAL INVESTIGATOR

• Manuel De Mora Martín, MD, PhD

  Hospital Regional U. Carlos Haya

  PRINCIPAL INVESTIGATOR

• Silvia López Fernández, MD

  University Hospital Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

• José Francisco Díaz Fernández, MD

  Hospital Universitario Juan Ramón Jimenez

  PRINCIPAL INVESTIGATOR

• Jesús Oneto Otero, MD

  Hospital de Jerez

  PRINCIPAL INVESTIGATOR

• Rafael Ruiz Salmerón, MD

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: January 6, 2014
• Primary Completion: October 19, 2018
• Study Completion: April 21, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

ES (9)