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

Primary Purpose

Old Myocardial Infarction

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous autologous myoblast implantation
Cardiac revascularization
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Myocardial Infarction focused on measuring Percutaneous implantation of autologous myoblasts

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Universitaria de Navarra
  • Hospital Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Skeletal myoblasts

No cells

Arm Description

Percutaneous autologous myoblast implantation

Percutaneous culture medium without cells implantation

Outcomes

Primary Outcome Measures

Ejection fraction and wall motion score index measured with M-mode and echocardiography

Secondary Outcome Measures

Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population
Viability measured with echocardigraphy and magnetic resonance in the ITT population
Incidence of cardiac arrythmias in the ITT population
Ejection fraction measured with echocardiography in the ITT population

Full Information

First Posted
May 25, 2009
Last Updated
September 10, 2015
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Finabiotech
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1. Study Identification

Unique Protocol Identification Number
NCT00908622
Brief Title
Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction
Acronym
PERCUTANEO
Official Title
Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Finabiotech

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Myocardial Infarction
Keywords
Percutaneous implantation of autologous myoblasts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skeletal myoblasts
Arm Type
Experimental
Arm Description
Percutaneous autologous myoblast implantation
Arm Title
No cells
Arm Type
Placebo Comparator
Arm Description
Percutaneous culture medium without cells implantation
Intervention Type
Procedure
Intervention Name(s)
Percutaneous autologous myoblast implantation
Other Intervention Name(s)
Cellular therapy
Intervention Description
Endocavity implantation of autologous myoblasts
Intervention Type
Procedure
Intervention Name(s)
Cardiac revascularization
Intervention Description
Cardiac revascularization
Primary Outcome Measure Information:
Title
Ejection fraction and wall motion score index measured with M-mode and echocardiography
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population
Time Frame
12 month after surgery
Title
Viability measured with echocardigraphy and magnetic resonance in the ITT population
Time Frame
12 month after surgery
Title
Incidence of cardiac arrythmias in the ITT population
Time Frame
12 month after surgery
Title
Ejection fraction measured with echocardiography in the ITT population
Time Frame
12 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Prósper, MD, Ph.D.
Organizational Affiliation
Clínica Universidad de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

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

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