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

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908622
First Posted: May 27, 2009
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Finabiotech
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
  Purpose
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 Intervention Phase
Old Myocardial Infarction Procedure: Percutaneous autologous myoblast implantation Procedure: Cardiac revascularization Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Ejection fraction and wall motion score index measured with M-mode and echocardiography [ Time Frame: 12 months after surgery ]

Secondary Outcome Measures:
  • Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population [ Time Frame: 12 month after surgery ]
  • Viability measured with echocardigraphy and magnetic resonance in the ITT population [ Time Frame: 12 month after surgery ]
  • Incidence of cardiac arrythmias in the ITT population [ Time Frame: 12 month after surgery ]
  • Ejection fraction measured with echocardiography in the ITT population [ Time Frame: 12 month after surgery ]

Enrollment: 38
Study Start Date: March 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Skeletal myoblasts
Percutaneous autologous myoblast implantation
Procedure: Percutaneous autologous myoblast implantation
Endocavity implantation of autologous myoblasts
Other Name: Cellular therapy
Placebo Comparator: No cells
Percutaneous culture medium without cells implantation
Procedure: Cardiac revascularization
Cardiac revascularization

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908622


Locations
Spain
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
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
  More Information

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00908622     History of Changes
Other Study ID Numbers: MIO/REG/PERCUTÁNEO
First Submitted: May 25, 2009
First Posted: May 27, 2009
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Percutaneous implantation of autologous myoblasts

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases