Ischemic Heart FailurePhase 2NCT00102128
Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.
A Phase 2 study testing Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation) in people with Ischemic Heart Failure and Ischemic Heart Disease, run by Genzyme, a Sanofi Company at 28 sites in 6 countries.
Trial summary
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Failure, Ischemic Heart Disease, Ischemic Cardiomyopathy
- What is being tested?
- Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
- How many people
- Not given
- Where
- 28 sitesin 6 countries
- Study dates
- Nov 2002to Apr 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support)
- Ejection fraction ≥15% and ≤35%
- Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening
Who cannot join
- Need for a rapid surgical coronary revascularization
- Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement)
- Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)
- Cardiomyopathy presumed to be of non-ischemic origin
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
France12 sites
Genzyme Corporation
Besançon
Genzyme Corporation
Bordeaux
Genzyme Corporation
Caen
Genzyme Corporation
Clermont-Ferrand
Genzyme Corporation
Grenoble
Genzyme Corporation
Lille
Genzyme Corporation
Lyon
Genzyme Corporation
Nantes
Genzyme Corporation
Paris
Genzyme Corporation
Rennes
Genzyme Corporation
Rouen
Genzyme Corporation
Toulouse
Italy5 sites
Genzyme Corporation
Bologna
Genzyme Corporation
Genova
Genzyme Corporation
Milan
Genzyme Corporation
Treviso
Genzyme Corporation
Udine
Belgium4 sites
Genzyme Corporation
Aalst
Genzyme Corporation
Brussels
Genzyme Corporation
Ghent
Genzyme Corporation
Leuven
Germany3 sites
Genzyme Corporation
Bad Oeynhausen
Genzyme Corporation
Hamburg
Genzyme Corporation
Hanover
United Kingdom3 sites
Genzyme Corporation
Cambridge
Genzyme Corporation
London
Genzyme Corporation
Southampton
About this study
Official title: Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
- Being tested
- Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography
Secondary outcomes (1)
Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2005 (estimated)
- Study startNov 2002
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: DMC recommended stop
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies 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
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102128
- Sponsor's protocol ID
- SMC00202
- Status last verified
- May 2015
- First submitted
- 21 Jan 2005
- Last updated
- 22 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT00102128
- Acronym / sponsor ID
- SMC00202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DMC recommended stop
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 24 Jan 2005 (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.
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support)
- Ejection fraction ≥15% and ≤35%
- Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening
Key exclusion criteria (4 listed)
- Need for a rapid surgical coronary revascularization
- Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement)
- Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)
- Cardiomyopathy presumed to be of non-ischemic origin
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 |
|---|---|---|
| Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation) | Drug | – |
Primary outcome
Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography
1 secondary outcome
Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke.
Results and safety
The study was stopped early (reason given: DMC recommended stop). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation) in people with Ischemic Heart Failure and Ischemic Heart Disease, run by Genzyme, a Sanofi Company at 28 sites in 6 countries.
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 3 inclusion and 4 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Italy, Belgium, Germany, United Kingdom and 1 more country. 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. 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: DMC recommended stop). 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?
Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography. 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 22 May 2015.