Treatment With Autologous Skeletal Myoblasts

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborator:
Fina Biotech
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00975234
First received: September 10, 2009
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Old Myocardial Infarction
Procedure: Intra-lesion injection of autologous skeletal myoblasts
Procedure: Revascularisation
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, Randomised, Controlled Study of Treatment With Revascularisation Surgery With or Without Injection of Autologous Skeletal Myoblasts in Patients With Old Myocardial Infarction

Resource links provided by NLM:


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

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. [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias. [ Time Frame: 12 month after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: May 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Skeletal myoblasts
Patients who are receiving skeletal myoblasts
Procedure: Intra-lesion injection of autologous skeletal myoblasts
Intra-lesion injection
Procedure: Revascularisation
Revascularisation surgery
Placebo Comparator: Placebo
Revascularisation surgery
Procedure: Revascularisation
Revascularisation surgery

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00975234

Locations
Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Hospital La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Fina Biotech
Investigators
Study Director: Felipe Prósper, MD, PhD Clinica Universidad de Navarra
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00975234     History of Changes
Other Study ID Numbers: Mio/Reg/Quirur/Aleatorizado
Study First Received: September 10, 2009
Last Updated: June 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Intra-lesion injection of autologous myoblasts

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

ClinicalTrials.gov processed this record on July 24, 2014