Clinical trial NCT00375817: Safety and Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) Using an Injection Catheter = SEISMIC Trial
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myocardial Infarction
Heart Failure, Congestive
Lead sponsor: Bioheart, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Overall Objective
measure: To assess the effect and safety of MyoCell™ therapy on myocardial function in congestive heart failure patients, post-myocardial infarction(s). Primary Safety Objective
measure: The primary safety objective defined for this study is as follows:
measure: 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
measure: Primary MyoCellTM Efficacy Objective
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Sunrise
country: United States
facility: Richard Spencer
state: Florida
Study officials:
affiliation: Cardiovascular Center, Aalst
name: Jozef - Bartunek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glenfield Hospital, University Hospitals of Leicester
name: Anthony - Gershlick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freiburg
name: Christoph - Hehrlein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico San Carlos, Spain
name: Carlos - Macaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University, Rostock, Germany
name: Christoph - Nienaber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Mary's Hospital & Imperial College, London
name: Nicholas - Peters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaires Herzzentrum Hamburg, Germany
name: Joachim - Schofer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thorax Centre-Erasmus University, The Netherlands
name: Patrick - Serruys, MD
role: STUDY_CHAIR
affiliation: Cardiac & Rehabilitation Hospital at Kowanowko,Poland
name: Tomasz - Siminiak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medisch Centrum, Rijnmond Zuid, The Netherlands
name: Peter - Smits, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Ziekenhuis Maastrict, The Netherlands
name: J. - Waltenberger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ZOL Campus St. Jan, Genk, Belgium
name: Walter Van Mieghem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Liege, Belgium
name: Victor Legrand, MD
role: PRINCIPAL_INVESTIGATOR
References: