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

Bioheart

Status and phase

Unknown

Phase 2

Conditions

Heart Failure, Congestive

Myocardial Infarction

Treatments

Procedure: Myoblasts injection with MyoCath catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00375817

BMI-EU-02-008

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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