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PERCUTANEO: Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra (Other)
Overall Status
Terminated
CT.gov ID
NCT00908622
Collaborator
Finabiotech (Other)
38
Enrollment
2
Locations
2
Arms
63
Duration (Months)
19
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous autologous myoblast implantation
  • Procedure: Cardiac revascularization
 Phase 2

Detailed Description

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Skeletal myoblasts

Percutaneous autologous myoblast implantation

Procedure: Percutaneous autologous myoblast implantation
Endocavity implantation of autologous myoblasts
Other Names:
  • Cellular therapy

    		•
    Placebo Comparator: No cells

    Percutaneous culture medium without cells implantation

    Procedure: Cardiac revascularization
    Cardiac revascularization

    Outcome Measures

    Primary Outcome Measures

    1. Ejection fraction and wall motion score index measured with M-mode and echocardiography [12 months after surgery]

    Secondary Outcome Measures

    1. Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population [12 month after surgery]

    2. Viability measured with echocardigraphy and magnetic resonance in the ITT population [12 month after surgery]

    3. Incidence of cardiac arrythmias in the ITT population [12 month after surgery]

    4. Ejection fraction measured with echocardiography in the ITT population [12 month after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with diagnosis of myocardial infarction, absence of viability.

    • Ejection fraction under 40% or 45% in symptomatic patients

    • Aged from 30-80 years old.

    • Negative pregnancy test (women of childbearing age)

    • Informed consent granted

    Exclusion Criteria:

    • Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI).

    • Myocardial infarction with more than 10 years of evolution.

    • Patients positive for HIV, HBV or HCB.

    • Patients with organ dysfunction: liver and kidney function

    • History of cancer or prior treatment with chemotherapy.

    • The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.

    • Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.

    • Pregnant or beast feeding women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clínica Universitaria de Navarra Pamplona Navarra Spain 31008
    2 Hospital Gregorio Marañón Madrid Spain 28007

    Sponsors and Collaborators

    • Clinica Universidad de Navarra, Universidad de Navarra
    • Finabiotech

    Investigators

    • Study Director: Felipe Prósper, MD, Ph.D., Clínica Universidad de Navarra

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinica Universidad de Navarra, Universidad de Navarra
    ClinicalTrials.gov Identifier:
    NCT00908622
    Other Study ID Numbers:
    • MIO/REG/PERCUTÁNEO
    First Posted:
    May 27, 2009
    Last Update Posted:
    Sep 11, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra
    Percutaneous implantation of autologous myoblasts
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Sep 11, 2015