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

September 10, 2015 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañon
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ejection fraction and wall motion score index measured with M-mode and echocardiography
Time Frame: 12 months after surgery
12 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Finabiotech

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 25, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIO/REG/PERCUTÁNEO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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