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

NCT00908622 | Terminated Phase 2

• 1 other identifier: MIO/REG/PERCUTÁNEO
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Old Myocardial Infarction

Keywords

Percutaneous implantation of autologous myoblasts

Outcome Measures

Primary Outcomes (1)

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

  12 months after surgery

Secondary Outcomes (4)

• Wall motion score index measured with echocardigraphy and magnetic resonance in the ITT population

  12 month after surgery

• Viability measured with echocardigraphy and magnetic resonance in the ITT population

  12 month after surgery

• Incidence of cardiac arrythmias in the ITT population

  12 month after surgery

• Ejection fraction measured with echocardiography in the ITT population

  12 month after surgery

Study Arms (2)

Skeletal myoblasts

EXPERIMENTAL

Percutaneous autologous myoblast implantation

Procedure: Percutaneous autologous myoblast implantation

No cells

PLACEBO COMPARATOR

Percutaneous culture medium without cells implantation

Procedure: Cardiac revascularization

Interventions

Percutaneous autologous myoblast implantation PROCEDURE

Endocavity implantation of autologous myoblasts

Also known as: Cellular therapy

Skeletal myoblasts

Cardiac revascularization PROCEDURE

Cardiac revascularization

No cells

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Finabiotech: collaborator

Study Sites (2)

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Interventions

Cell- and Tissue-Based Therapy; Myocardial Revascularization

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Felipe Prósper, MD, Ph.D.

  Clínica Universidad de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2009
• First Posted: May 27, 2009
• Study Start: March 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 11, 2015

Record last verified: 2015-09

Locations

ES (2)