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:
Collaborator:
Finabiotech
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00908622
First received: May 25, 2009
Last updated: September 10, 2015
Last verified: September 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population [ Time Frame: 12 month after surgery ] [ Designated as safety issue: Yes ]
  • Viability measured with echocardigraphy and magnetic resonance in the ITT population [ Time Frame: 12 month after surgery ] [ Designated as safety issue: No ]
  • Incidence of cardiac arrythmias in the ITT population [ Time Frame: 12 month after surgery ] [ Designated as safety issue: No ]
  • Ejection fraction measured with echocardiography in the ITT population [ Time Frame: 12 month after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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 
Study First Received: May 25, 2009
Last Updated: September 10, 2015
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on May 05, 2016