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.

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Brief Title

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.

Official Title

Multicenter Phase IIb 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.

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Changes in ventricular function measured angiographically.

Secondary Outcome

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

Condition

Idiopathic Dilated Cardiomyopathy

Intervention

Infusion of autologous mononuclear bone marrow cells

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

27

Start Date

January 6, 2014

Completion Date

April 2020

Primary Completion Date

April 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Patients of both sexes and ages between 18 and 70 years.

          2. Patients diagnosed with dilated cardiomyopathy established by echocardiography.

          3. Minimum evolution since diagnosis of 6 months.

          4. 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.

          5. Patients receiving optimized 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 is > 110 ml/m2.

          7. Presence of sinus rhythm.

          8. Writen informed consent for participation in the trial.

          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; Haemoglobin > 9 g/dL

         10. Women of childbearing potential must have negative results on a pregnancy test and
             agree to use medically approved methods of contraception thoughout follow up.

        Exclusion Criteria:

          1. Secondary Dilated cardiomyopathy.

          2. Recent history of myocarditis (< 6 months prior to study entry).

          3. Patients amenable to receive cardiac resynchronization therapy

          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 or breastfeeding women; or women of childbearing potential not comminting to
             use effective contraception.

          8. 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.

          9. Patients with malignant or pre-malignant tumors.

         10. Positive serology for hepatitis B virus, hepatitis C virus or human immunodeficiency
             virus.

         11. Use of any protocolo prohibited medication. A wash-out period of 2 months can be
             considered for inclusion in the trial.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Miguel Romero Moreno, MD, PhD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT02033278

Organization ID

CMMo/MD/2013


Responsible Party

Sponsor

Study Sponsor

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

Collaborators

 Iniciativa Andaluza en Terapias Avanzadas

Study Sponsor

Miguel Romero Moreno, MD, PhD, Principal Investigator, Hospital Universitario Reina Sofía


Verification Date

March 2020