- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00050765
Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
A Phase I Multi-Center Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation in Patients With a Previous MI and Placement of an ICD Requiring De Novo Coronary Artery Bypass Graft Therapy
Study Overview
Status
Intervention / Treatment
Detailed Description
MyoCell™ mediated cellular cardiomyoplasty is a novel therapeutic approach to the management of progressive heart failure in patients who have damaged myocardial tissue resulting from a myocardial infarct. MyoCell™ consists of patient autologous skeletal myoblasts which are expanded ex vivo and supplied as a cell suspension in a buffered salts solution for injection into the area of damaged, akinetic myocardium with the goal of having the myoblasts populate the implant area and generate elastic, contractile skeletal muscle-like tissue within the damaged myocardium. Because the physiological goal is to replace inelastic, fibrous myocardial scar tissue with skeletal muscle-like tissue, originating from the cellular implants, this therapeutic approach is termed "cellular cardiomyoplasty" or "CCM".
The purpose of this trial is to assess the safety of MyoCell™(expanded autologous skeletal myoblasts) using a dose escalation methodology following epicardial injection into myocardial scar tissue in patients who have experienced anterior, lateral, posterior or inferior wall myocardial infarction, require coronary artery bypass graft (CABG) surgery and who have an implantable cardioverter defibrillator (ICD) in place (ICD can be implanted during the CABG procedure or 3 to 4 days post CABG procedure). Safety endpoints will be the evaluation of the nature and frequency of Adverse Events during the 12-month period following MyoCell™ treatment.
If a patient meets the baseline enrollment criteria, a 5-10 gram skeletal muscle biopsy will be obtained for myoblast isolation and expansion in vitro at Bioheart's designated facility for MyoCell™ production. Biopsy will occur 3 - 4 weeks prior to the anticipated implantation of the MyoCell™ product. At the time of the patient's CABG surgery MyoCell™ will be injected into the akinetic myocardial scar in the region of a previous infarct utilizing a sterile hypodermic syringe fitted with a 25 gauge needle.
This will be a dose escalation study with 3 cohort groups consisting of 5 patients each. A report of the 1 month safety data from each cohort will be presented to the data safety monitoring board for permission to go to the next higher dosage. In the first cohort of this dose escalation study; 2 injections will be performed, for the second cohort; 6 injections and for the third cohort; 18 injections depending on the size of the infarct scar, so as to inject the entire myocardial infarct scar akinetic area.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Doug Owens, RN, BSN
- Phone Number: 100 (954) 835-1500
- Email: dowens@bioheartinc.com
Study Locations
-
-
Florida
-
Ft. Lauderdale, Florida, United States, 33326
- Bioheart, Inc
-
Contact:
- Richard Spencer, JD, MBA
- Phone Number: (954) 835-1500
- Email: RSpencer@bioheartinc.com
-
Contact:
- Doug Owends, RN, BSN, CCRA
- Phone Number: (954) 835-1500
- Email: dowens@bioheartinc.com
-
Principal Investigator:
- Warren Sherman, MD
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- ACRI
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
-
Contact:
- Gary Schaer, MD FACC
- Phone Number: 312-942-4655
- Email: gschaer@rush.edu
-
Contact:
- Carrie Schlaffer, BS, CCRC
- Phone Number: (312) 942-8901
- Email: Carrie_Schlaffer@rush.edu
-
Principal Investigator:
- Gary L Schaer, MD FACC
-
Sub-Investigator:
- Robert March, MD
-
-
New York
-
New York, New York, United States, 10029
- Mt. Sinai Medical Center
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Defined region of myocardial dysfunction related to previous myocardial infarction involving the anterior, lateral, posterior or inferior walls, > 12 weeks old at the scheduled time of MyoCell™ implantation procedure
- Patients must have an implantable cardioverter defibrillator (ICD) in place or, patients must receive ICD placement during the CABG procedure or 3 to 4 days after the CABG procedure
- Planned CABG procedure for revascularization
- Heart failure patient in New York Heart Association Symptom Class 2 or 3 who is on optimal medical therapy
- Age > 18 and < 80 years
- Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts
- Target region wall thickness > 6 mm by echocardiography
- Left ventricular ejection fraction > 20% and < 40% by radionuclide ventriculography or left ventricular angiography at screening
- If a female of childbearing potential, urine pregnancy test must be negative
- Able to give written informed consent
Exclusion Criteria:
- Patient medically unable to undergo CABG surgery
- Any patient who has had a documented myocardial infarction (ECG changes or elevated cardiac enzymes consistent with MI) within 30 days of the scheduled surgical revascularization and cellular implantation procedure.
- Known sensitivity to gentamicin sulfate and/or amphotericin-B
- Exposure to any investigational drug or procedure within 4 weeks prior to study entry
- The use or expected use of antineoplastic drugs
- History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.) as determined by a board certified pathologist examining sample of patients muscle biopsy
- Previous angiogenic therapy and/or myocardial laser therapy
- History of cancer within 5 years, except for basal cell carcinoma of the skin
- PSA suggestive of carcinoma of the prostate (i.e., > 4)
- Patient with CEA >2.5 ng/mL or end stage renal disease
- Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis. If the panel includes antibodies to the HBc and HBV-sAg, then an expert will be consulted.
- Females who are pregnant or nursing. Females of childbearing potential must be using to the investigator's satisfaction, a medically accepted method of birth control (e.g., but not limited to, oral or implanted contraceptive therapy or intrauterine devices) and agree to continue for the duration of the study.
- Any illness which might affect patient's survival over the study follow-up period
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
- Patient with an any previous cardiac surgery
- Patient with valvular disease greater than mild in degree which is considered the primary cause of their heart failure
- Patient in New York Heart Association Symptom Class 1 or 4
- Patient with serum creatinine > 2.5
- No informed consent or unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol BMI-US-01-001
- Version F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on MyoCell™ Autologous Myoblasts
-
Bioheart, Inc.UnknownMyocardial Infarction | Coronary Artery Disease | Congestive Heart FailureUnited States
-
Assistance Publique - Hôpitaux de ParisAssociation Française contre les Myopathies (AFM), ParisCompletedMuscular Dystrophy, OculopharyngealFrance
-
Clinica Universidad de Navarra, Universidad de...Fina BiotechTerminated
-
Avita MedicalCompletedDiabetic Foot UlcerUnited Kingdom
-
Johannes Gutenberg University MainzCompleted
-
ProChon Biotech LtdUnknownSymptomatic Cartilage Defects of the Femoral CondyleUnited States, Israel
-
M.C. Kruyt, MD, PhDKuros BioSciences B.V.Active, not recruitingSpinal FusionNetherlands
-
Castle Creek Biosciences, LLC.CompletedDysphonia Resulting From Vocal Fold Scarring | Age-related DysphoniaUnited States
-
Avita MedicalBiomedical Advanced Research and Development AuthorityTerminatedSkin; DeformityUnited States
-
Arteriocyte, Inc.Department of Health and Human ServicesUnknownAcute Deep Partial Thickness Thermal BurnsUnited States