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Treatment With Autologous Skeletal Myoblasts

Primary Purpose

Old Myocardial Infarction

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Intra-lesion injection of autologous skeletal myoblasts
Revascularisation
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 Intra-lesion injection of autologous myoblasts

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery.
  • History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years.
  • Ejection fraction from 25% to 45%.
  • Evidence of no regional viability by dobutamine echocardiography.
  • Aged from 30-80 years old.
  • Negative serology to HIV, HBV and HCV.
  • Patients without organ dysfunction.
  • Negative pregnancy test (women of childbearing age).
  • Informed consent granted.

Exclusion Criteria:

  • History of myocardial infarction in the 4 weeks prior to the inclusion in the study.
  • Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device).
  • History of cancer (except basocellular carcinoma) 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

  • Hospital Clínico Universitario de Santiago
  • Clínica Universitaria de Navarra
  • Hospital Gregorio Marañón
  • Hospital Clínico San Carlos
  • Hospital Clínico Universitario de Salamanca
  • Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Skeletal myoblasts

Placebo

Arm Description

Patients who are receiving skeletal myoblasts

Revascularisation surgery

Outcomes

Primary Outcome Measures

The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.

Secondary Outcome Measures

Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.

Full Information

First Posted
September 10, 2009
Last Updated
June 7, 2012
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Fina Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00975234
Brief Title
Treatment With Autologous Skeletal Myoblasts
Official Title
Phase II, Randomised, Controlled Study of Treatment With Revascularisation Surgery With or Without Injection of Autologous Skeletal Myoblasts in Patients With Old Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.
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. Depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (HF) syndrome. The molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. In the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. There are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. The objective of this study is compare improvement in global and regional cardiac function in patients with old MI obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Myocardial Infarction
Keywords
Intra-lesion injection of autologous myoblasts

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Skeletal myoblasts
Arm Type
Experimental
Arm Description
Patients who are receiving skeletal myoblasts
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Revascularisation surgery
Intervention Type
Procedure
Intervention Name(s)
Intra-lesion injection of autologous skeletal myoblasts
Intervention Description
Intra-lesion injection
Intervention Type
Procedure
Intervention Name(s)
Revascularisation
Intervention Description
Revascularisation surgery
Primary Outcome Measure Information:
Title
The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.
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 a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery. History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years. Ejection fraction from 25% to 45%. Evidence of no regional viability by dobutamine echocardiography. Aged from 30-80 years old. Negative serology to HIV, HBV and HCV. Patients without organ dysfunction. Negative pregnancy test (women of childbearing age). Informed consent granted. Exclusion Criteria: History of myocardial infarction in the 4 weeks prior to the inclusion in the study. Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device). History of cancer (except basocellular carcinoma) 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, PhD
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
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
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

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Treatment With Autologous Skeletal Myoblasts

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