Safety and Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) Using an Injection Catheter = SEISMIC Trial - Full Text View

Sponsor:	Bioheart, Inc.
Information provided by:	Bioheart, Inc.
ClinicalTrials.gov Identifier:	NCT00375817

Purpose

To assess the efficacy and safety of MyoCell therapy on myocardial function in congestive heart failure patients, post-myocardial infarction

Condition	Intervention	Phase
Myocardial Infarction Heart Failure, Congestive	Procedure: Myoblasts injection with MyoCath catheter	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II, Open-Label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCell Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Heart Failure

U.S. FDA Resources

Further study details as provided by Bioheart, Inc.:

Primary Outcome Measures:

Overall Objective
To assess the effect and safety of MyoCell™ therapy on myocardial function in congestive heart failure patients, post-myocardial infarction(s). Primary Safety Objective
The primary safety objective defined for this study is as follows:
The MyoCell™ implant will be considered safe if the number of serious adverse events at 3 months and 6 months is less than that seen in the control group (receiving standard medical therapy), and falling within levels set in the statistical analysis pla
Primary MyoCellTM Efficacy Objective
The primary efficacy objective of SEISMIC is to demonstrate the response to MyoCell™ implantation on the change in LVEF at 3 and 6 months by MUGA compared to baseline. Comparisons on LVEF will also be made between the two randomized groups (i.e. MyoCell

Enrollment:	40
Study Start Date:	November 2005
Estimated Study Completion Date:	January 2008

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

defined region of myocardial dysfunction related to previous MI (most recent MI at least 90 days prior to muscle biopsy involving the anterior, lateral, posterior or inferior walls, assessed by the presence of a Q-wave on the ECG & a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography
NYHA class II or III
on optimal medical drug therapy for at least 2 months prior to study entry; defined by the most current ACC/AHA guidelines for the Evaluation & Management of chronic heart failure in the adult
>=18 and <=75 years old
need or feasibility for re-vascularization has been r/o by coronary or noninvasive stress testing within 30 days of screening, assessed using Dobutamine Stress Echocardiography
able to undergo surgical biopsy of the skeletal muscle & successful culture of the harvested myoblasts
well demarcated transmural myocardial scar (by echocardiography)Must have a minimum myocardial wall thickness of 5mm
must have been fitted w/ an ICD in place for the duration of the study at least 6 months prior to muscle biopsy
left ventricular EF at screening of >=20%, <=45% (by MUGA)
willing & able to give written informed consent
if female of childbearing potential, serum or urine pregnancy test must be negative w/in 2 weeks of study treatment

Exclusion Criteria:

MI w/in 90 days of the muscle biopsy
NYHA class I or IV
CABG w/in 6 months (180 days) prior to scheduled MyoCell implantation
PCI w/in 3 months (90 days) prior to scheduled MyoCell implantation
aortic valve replacement
heart failure secondary to valvular disease
left ventricular mural thrombus
known sensitivity to gentamicin sulfate and/or amphotericin-B
previous experimental angiogenic therapy and/or myocardial laser therapy
previous severe adverse reaction to nonionic radiocontrast agents
exposure to any investigational drug or procedure w/in 1 month prior to study entry or enrolled in any concurrent study that may confound the results of this study
serum creatinine >2.5 mg/dL or end stage renal disease
active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM>IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient's infectious status
females who are pregnant or nursing or of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
any illness which might affect patient's survival over the study follow up period or 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
patients on chronic immunosuppressive transplant therapy
ICDs implanted less than 6 months prior to cellular implantation procedure. ICDs reprogrammed during the course of treatment and stable for less than 3 months. Patients fitted w/a Bi-V pacer are excluded.
patients who, in the opinion of the investigator, are not suitable to participate, following review of the catheter information in appendix IV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375817

Locations

United States, Florida
Richard Spencer
Sunrise, Florida, United States, 33325

Sponsors and Collaborators

Bioheart, Inc.

Investigators

Principal Investigator:	Jozef - Bartunek, MD	Cardiovascular Center, Aalst
Principal Investigator:	Anthony - Gershlick, MD	Glenfield Hospital, University Hospitals of Leicester
Principal Investigator:	Christoph - Hehrlein, MD	University of Freiburg
Principal Investigator:	Carlos - Macaya, MD	Hospital Clinico San Carlos, Spain
Principal Investigator:	Christoph - Nienaber, MD	University, Rostock, Germany
Principal Investigator:	Nicholas - Peters, MD	St Mary's Hospital & Imperial College, London
Principal Investigator:	Joachim - Schofer, MD	Universitaires Herzzentrum Hamburg, Germany
Study Chair:	Patrick - Serruys, MD	Thorax Centre-Erasmus University, The Netherlands
Principal Investigator:	Tomasz - Siminiak, MD	Cardiac & Rehabilitation Hospital at Kowanowko,Poland
Principal Investigator:	Peter - Smits, MD	Medisch Centrum, Rijnmond Zuid, The Netherlands
Principal Investigator:	J. - Waltenberger, MD	Academisch Ziekenhuis Maastrict, The Netherlands
Principal Investigator:	Walter Van Mieghem, MD	ZOL Campus St. Jan, Genk, Belgium
Principal Investigator:	Victor Legrand, MD	University Hospital, Liege, Belgium

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00375817 History of Changes
Other Study ID Numbers:	BMI-EU-02-008
Study First Received:	September 11, 2006
Last Updated:	October 11, 2007
Health Authority:	The Netherlands: Germany: Belgium: Spain: UK: Poland: Ministries of Health

Additional relevant MeSH terms:

Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases

Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012