Treatment With Autologous Skeletal Myoblasts

June 7, 2012 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Phase II, Randomised, Controlled Study of Treatment With Revascularisation Surgery With or Without Injection of Autologous Skeletal Myoblasts in Patients With Old Myocardial Infarction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Valencia, Spain, 46009
        • Hospital La Fe
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Hospital Clínico Universitario de Santiago
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fina Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Felipe Prosper, MD, PhD, 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mio/Reg/Quirur/Aleatorizado

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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