NCT00975234

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

September 10, 2009

Last Update Submit

June 7, 2012

Conditions

Old Myocardial Infarction

Keywords

Intra-lesion injection of autologous myoblasts

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months after surgery

Secondary Outcomes (1)

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

    12 month after surgery

Study Arms (2)

Skeletal myoblasts

EXPERIMENTAL

Patients who are receiving skeletal myoblasts

Procedure: Intra-lesion injection of autologous skeletal myoblastsProcedure: Revascularisation

Placebo

PLACEBO COMPARATOR

Revascularisation surgery

Procedure: Revascularisation

Interventions

Intra-lesion injection of autologous skeletal myoblastsPROCEDURE

Intra-lesion injection

Skeletal myoblasts
RevascularisationPROCEDURE

Revascularisation surgery

PlaceboSkeletal myoblasts

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

Study Officials

  • Felipe Prósper, MD, PhD

    Clinica 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

September 10, 2009

First Posted

September 11, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

ES(6)