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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT02033278
First received: January 9, 2014
Last updated: July 29, 2015
Last verified: June 2015
  Purpose

Clinical trial phase II-III, 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.


Condition Intervention Phase
Idiopathic Dilated Cardiomyopathy
Drug: Infusion of autologous mononuclear bone marrow cells
Drug: Placebo infusion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Phase II-III Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.

Resource links provided by NLM:


Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Changes in ventricular function determined angiographically [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of clinical improvement based on the absence of major cardiac events (MACE) during follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Presence or absence of symptoms or arrhythmias [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evolution time since diagnosis of idiopathic dilated cardiomyopathy to the inclusion of the patient. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: January 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infusion of autologous mononuclear bone marrow cells
Infusion of autologous mononuclear bone marrow cells more conventional medical treatment
Drug: Infusion of autologous mononuclear bone marrow cells
Infusion of autologous mononuclear bone marrow cells more conventional medical treatment
Placebo Comparator: Placebo infusion
Placebo infusion more conventional medical treatment
Drug: Placebo infusion
Placebo infusion more conventional medical treatment

Detailed Description:

The study population correspond to male and female patients with idiopathic dilated cardiomyopathy.

51 patients diagnosed with this disease are included. After inclusion, will proceed to the random allocation to study group or control group in a 2:1 ratio, 34 patients in the treatment group and 17 in the control group.

The total duration is expected to be 48 months: The inclusion period is 24 months and each patient assigned to the experimental group will be followed for 24 months, whereas that one ramdomized to the control group, will have a folow-up of 12 months. Upon completion there of, the patients will be followed in routine clinical practice.

This is a double blind study, in which all patients will perform the bone marrow harvesting.

All patients will receive the best medical treatment individualized (ACEIs or Angiotensin II receptor blocker, beta-blockers, diuretics and eplerenone) for at least 6 months prior to their participation in the clinical trial, so that the situation is stable and pharmacological basal condition is the same for everyone.

The bone marrow cells of patients assigned to placebo group will be cryopreserved, and once the trial is completed, the blind will be opened and all the patients who had been randomized to the control group, may be processed by the route of compassionate use with their own mononuclear bone marrow cells previously frozen.

The patients who are randomized to experimental group will be treated by the conventional treatment + infusion of autologous mononuclear bone marrow cells not expanded whereas the patients who are randomized to control group will be treated by the conventional treatment + infusion of placebo.

The main objective is to assess comparative the efficacy of intracoronary injection of bone marrow stem cells autologous to improve ventricular function in patients with idiopathic dilated cardiomyopathy who receive conventional medical treatment, compared with a control group who receive a infusion of placebo and conventional medical treatment. The improvement in ventricular function assessed by changes in angiographically determined ejection fraction.

Secondary objectives of the study are:

- To analyze the predictors of good clinical response, functional and biological treatment with adult stem cells autologous mononuclear bone marrow not expanded in terms of functional recovery.

The following parameters were evaluated: Functional class (NYHA), Natriuretic peptide B, Stress test (exercise time), Echocardiographic parameters of ventricular function, for example LVEF (%), TDV (ml), TSV (ml) and TAPSE (ms) and Biological parameters of cellular functionality, for example CD133 +, CD34 +, CD34 +/CD177 + and CD34 +/CD38- in %.

- To determine, in the light of the obtained results, the application protocol suitable cell therapy for the treatment of dilated cardiomyopathy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes and ages between 18 and 70 years.
  2. Patients diagnosed with dilated cardiomyopathy established by echocardiography with symptoms and / or signs of heart failure of idiopathic etiology.
  3. Minimum evolution since diagnosis 6 months
  4. Absence of coronary lesions tested with multislice CT and / or hemodynamic study realized after the incorporation of the patient in the clinical trial or during 6 previous months the signature of the informed consent for participation in the clinical trial.
  5. Patients with stable 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> 110 ml/m2.
  7. Presence of sinus rhythm.
  8. Patients give their informed consent for participation in the clinical trial consent.
  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
  10. Women of childbearing potential must have negative results on a pregnancy test at the time of inclusion in the study and agree to use a medically approved method of contraception while on study.

Exclusion Criteria:

  1. Dilated cardiomyopathy of toxic origin, or ischemic storage diseases.
  2. Recent history of myocarditis.
  3. Patients amenable to treatment with resynchronization
  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 women, lactating, or of childbearing age not using effective contraception.
  8. Patients who are currently participating or have completed their participation in a clinical trial at a period less than 3 months.
  9. Patients with malignant or pre-malignant tumors
  10. Positive serology for hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
  11. Patients at the time of study entry are taking any medications prohibited by the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033278

Contacts
Contact: Ana Cardesa 0034 955014090 ana.cardesa@juntadeanlacia.es

Locations
Spain
Hospital Universitario Puerta del Mar Active, not recruiting
Cádiz, Spain
Hopistal Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: José Suárez de Lezo Cruz-Conde, MD, PhD         
Principal Investigator: José Suárez de Lezo Cruz-Conde, MD, PhD         
Hopistal Universitario Virgen de la Victoria Active, not recruiting
Málaga, Spain
Hospital Regional U. Carlos Haya Recruiting
Málaga, Spain, 29014
Contact: Manuel De Mora Martín, MD, PhD         
Principal Investigator: Manuel De Mora Martín, MD, PhD         
Hospital Universitario de Valme Recruiting
Sevilla, Spain, 41014
Contact: Luis Pastor Torre, MD, PhD         
Principal Investigator: Luis Pastor Torre, MD, PhD         
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
Study Chair: José Suárez de Lezo Cruz Conde, MD, PhD Hospital Universitario Reina Sofía
Principal Investigator: Eduardo de Teresa Galván, MD, PhD Hospital Universitario Virgen de la Victoria
Principal Investigator: Luis Pastor Torre, MD, PhD Hospital Universitario de Valme
Principal Investigator: Manuel Sancho Jaldón, MD, PhD Hospital Universitario Puerta del Mar
Principal Investigator: Manuel De Mora Martín, MD, PhD Hospital Regional U. Carlos Haya
  More Information

Additional Information:
No publications provided

Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02033278     History of Changes
Other Study ID Numbers: CMMo/MD/2013
Study First Received: January 9, 2014
Last Updated: July 29, 2015
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 30, 2015