Old Myocardial InfarctionPhase 2NCT00975234
Treatment With Autologous Skeletal Myoblasts
A Phase 2 study testing Intra-lesion injection of autologous skeletal myoblasts and Revascularisation in people with Old Myocardial Infarction, run by Clinica Universidad de Navarra, Universidad de Navarra at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Old Myocardial Infarction
- What is being tested?
- Intra-lesion injection of autologous skeletal myoblasts and Revascularisation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 6 sitesSpain
- Study dates
- May 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Patients without organ dysfunction.
- Negative pregnancy test (women of childbearing age).
- Informed consent granted.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Hospital La Fe
Valencia, Valencia, 46009
About this study
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
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.
Read the 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.
- Conditions
- Old Myocardial Infarction
- Being tested
- Intra-lesion injection of autologous skeletal myoblasts, Revascularisation
- Keywords
- Intra-lesion injection of autologous myoblasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-lesion injection of autologous skeletal myoblastsProcedure or surgery
Intra-lesion injection
RevascularisationProcedure or surgery
Revascularisation surgery
| Study group | Role | What they receive |
|---|---|---|
| Skeletal myoblasts | Experimental | Patients who are receiving skeletal myoblasts Receives: Procedure: Intra-lesion injection of autologous skeletal myoblasts; Procedure: Revascularisation |
| Placebo | Placebo comparator | Revascularisation surgery Receives: Procedure: Revascularisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (1)
Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.
Measured: 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Fina Biotech
- Responsible party
- Sponsor
- Investigators
- Felipe Prósper, MD, PhD, Study director, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975234
- Sponsor's protocol ID
- Mio/Reg/Quirur/Aleatorizado
- Status last verified
- Jun 2012
- First submitted
- 10 Sep 2009
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00975234
- Acronym / sponsor ID
- Mio/Reg/Quirur/Aleatorizado
- Conditions
- Old Myocardial Infarction
- Keywords
- Intra-lesion injection of autologous myoblasts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Fina Biotech
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skeletal myoblasts | Experimental | Procedure: Intra-lesion injection of autologous skeletal myoblasts, Procedure: RevascularisationPatients who are receiving skeletal myoblasts |
| Placebo | Placebo comparator | Procedure: RevascularisationRevascularisation surgery |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-lesion injection of autologous skeletal myoblastsIntra-lesion injection | Procedure or surgery | Skeletal myoblasts |
| RevascularisationRevascularisation surgery | Procedure or surgery | Placebo, Skeletal myoblasts |
Primary outcome
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
1 secondary outcome
Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.
Time frame: 12 month after surgery
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Prósper, MD, PhD study director
Clinica Universidad de Navarra
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intra-lesion injection of autologous skeletal myoblasts and Revascularisation in people with Old Myocardial Infarction, run by Clinica Universidad de Navarra, Universidad de Navarra at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.