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.
This study has been terminated.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00102128
First received: January 21, 2005
Last updated: August 3, 2009
Last verified: November 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Heart Failure Ischemic Heart Disease Ischemic Cardiomyopathy |
Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure |
Resource links provided by NLM:
MedlinePlus related topics:
Cardiomyopathy
Coronary Artery Disease
Heart Attack
Heart Diseases
Heart Failure
Scars
U.S. FDA Resources
Further study details as provided by Genzyme:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | March 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102128
Locations
| Belgium | |
| Genzyme Corporation | |
| Aalst, Belgium | |
| Genzyme Corporation | |
| Brussels, Belgium | |
| Genzyme Corporation | |
| Gent, Belgium | |
| Genzyme Corporation | |
| Leuven, Belgium | |
| France | |
| Genzyme Corporation | |
| Besancon, France | |
| Genzyme Corporation | |
| Bordeaux, France | |
| Genzyme Corporation | |
| Caen, France | |
| Genzyme Corporation | |
| Clermont Ferrand, France | |
| Genzyme Corporation | |
| Grenoble, France | |
| Genzyme Corporation | |
| Lille, France | |
| Genzyme Corporation | |
| Lyon, France | |
| Genzyme Corporation | |
| Nantes, France | |
| Genzyme Corporation | |
| Paris, France | |
| Genzyme Corporation | |
| Rennes, France | |
| Genzyme Corporation | |
| Rouen, France | |
| Genzyme Corporation | |
| Toulouse, France | |
| Germany | |
| Genzyme Corporation | |
| Bad Oeynhausen, Germany | |
| Genzyme Corporation | |
| Hamburg, Germany | |
| Genzyme Corporation | |
| Hannover, Germany | |
| Italy | |
| Genzyme Corporation | |
| Bologna, Italy | |
| Genzyme Corporation | |
| Genova, Italy | |
| Genzyme Corporation | |
| Milan, Italy | |
| Genzyme Corporation | |
| Treviso, Italy | |
| Genzyme Corporation | |
| Udine, Italy | |
| Switzerland | |
| Genzyme Corporation | |
| Lausanne, Switzerland | |
| United Kingdom | |
| Genzyme Corporation | |
| Cambridge, United Kingdom | |
| Genzyme Corporation | |
| London, United Kingdom | |
| Genzyme Corporation | |
| Southampton, United Kingdom | |
Sponsors and Collaborators
Genzyme
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
No publications provided
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00102128 History of Changes |
| Other Study ID Numbers: | SMC00202 |
| Study First Received: | January 21, 2005 |
| Last Updated: | August 3, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Heart Failure Ischemia Cardiomyopathies |
Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013