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)

ISRCTN	ISRCTN17181395
DOI	https://doi.org/10.1186/ISRCTN17181395
ClinicalTrials.gov (NCT)	NCT00375817
Protocol serial number	BMI-EU-02-008
Sponsor	Bioheart Inc. (USA)
Funder	Bioheart Inc. (USA)

Submission date: 01/03/2006
Registration date: 10/03/2006
Last edited: 28/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Richard Spencer
Scientific

13794 NW 4th Street
Suite 212
Sunrise
Florida
33325
United States of America

Phone	+1 954 835 1500
Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Open-label, randomized, multicenter study
Secondary study design	Randomised controlled trial
Scientific title	A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction
Study acronym	SEISMIC
Study objectives	Is MyoCell™ treatment effective for improving patients cardiac function? (where cardiac function is assessed by a series of measurements indicating improvement or degradation of patients cardiovascular function, exercise capacity, frequency of hospitalizations (both positive and negative), the length of stay, mechanical function and functional status)
Ethics approval(s)	Approved by the West Essex Local Research Ethics Committee (UK), 06/01/2006, reference number: 05/Q0301/46
Health condition(s) or problem(s) studied	Ischemic cardiomyopathy (heart failure)
Intervention	Cell delivery via needle injection catheter versus standard medical therapy
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	MyoCell
Primary outcome measure(s)	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 three months and six months is less than that seen in the control group (receiving standard medical therapy), and falling within levels set in the statistical analysis plan. In addition, the number and mean length of stay for hospitalizations will also be captured. Primary MyoCell™ efficacy objective: The primary efficacy objective of SEISMIC is to demonstrate the response to MyoCell™ implantation on the change in Left Ventricular Systolic Function (LVEF) at three and six months by MUGA compared to baseline. Comparisons on LVEF will also be made between the two randomized groups (i.e. MyoCell™ implantation and standard medical therapy).
Key secondary outcome measure(s)	Secondary Efficacy Objectives: The secondary efficacy objective will be defined in the statistical analysis plan and will include but not be limited to: 1. Six Minute Walk (6MW) distance, NYHA classification, average Quality of Life (QOL) score, hospitalization, readmissions or the need for medical treatment outside of hospitalizations 2. Contrast aided-dobutamine stress echo (using non-ionic contrast) and tissue doppler imaging for all patients to show improvements in: a. Global and regional contractility b. Wall thickness improvements c. Coronary perfusion d. A further optional objective will be to assess any changes in infarct size seen after three and six months, compared to baseline Secondary Safety Objectives: An additional safety objective will be to investigate the safety of the use of the MyoCath™, when used as a means of delivery of MyoCells™ for intracardiac implantation
Completion date	15/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	46
Key inclusion criteria	1. Defined region of myocardial dysfunction related to previous myocardial infarction (most recent myocardial infarction must have occurred 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 electrocardiogram (ECG) and a large area of akinesia in the left ventricle, confirmed by either left ventricular angiography or echocardiography 2. New York Heart Association (NYHA) symptom class II or III 3. Patients on optimal medical drug therapy for at least two months prior to study entry - defined as following the most current American College of Cardiology (ACC) or American Heart Association (AHA) guidelines for the evaluation and management of chronic heart failure in adults 4. Age ≥18 and ≤75 years old 5. Need or feasibility for re-vascularization has been ruled out by coronary angiogram or non-invasive stress testing within 30 days of screening, assessed using dobutamine stress echocardiography 6. Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts 7. Well demarcated transmural myocardial scar, assessed by echocardiography. Patients must have a minimum myocardial wall thickness of 5 mm. 8. Must have been fitted with an Implantable Cardioverter Defibrillator (ICD) in place for the duration of the study at least six months prior to muscle biopsy 9. Left ventricular ejection fraction at screening of ≥20% ≤45% (by multi-acquisition gated [MUGA] scan) 10. Willing and able to give written informed consent 11. If a female of childbearing potential, serum or urine pregnancy test must be negative within two weeks of study treatment
Key exclusion criteria	1. Myocardial infarction within 90 days of the patients muscle biopsy 2. New York Heart Association Symptom Class I or IV 3. Coronary Artery Bypass Grafting (CABG) within six months (180 days) prior to scheduled MyoCell™ implantation 4. Percutaneous Coronary Intervention (PCI) within three months (90 days) prior to scheduled MyoCell™ implantation 5. Aortic valve replacement 6. Heart failure secondary to valvular disease 7. Left ventricular mural thrombus 8. Known sensitivity to gentamicin sulfate and/or amphotericin-B 9. Previous experimental angiogenic therapy and/or myocardial laser therapy 10. Previous severe adverse reaction to non-ionic radiocontrast agents 11. Exposure to any investigational drug or procedure within one month prior to study entry or enrolled in any concurrent study that may confound the results of this study 12. Serum creatinine >2.5 mg/dl or end stage renal disease 13. Active infectious disease and/or known to have tested positive for Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Cytomegalovirus (CMV) (IgM > IgG) and/or syphilis. If the panel includes antibodies to the anti-hepatitis B virus core antigen (HBV-cAg) and anti-hepatitis B virus surface antigen (HBV-sAg), then an expert will be consulted as to patient eligibility based on the patients infectious status. 14. Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study 15. Any illness which might affect patients survival over the study follow-up period or any illness which, in the investigators judgment, will interfere with the patients ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results 16. Patients on chronic immunosuppressive transplant therapy 17. ICDs implanted less than six months prior to cellular implantation procedure. ICD devices reprogrammed during the course of treatment and stable for less than three months. Patients fitted with a Bi-V pacer are excluded.
Date of first enrolment	15/03/2006
Date of final enrolment	15/06/2006

Locations

Countries of recruitment

United Kingdom
Belgium
Germany
Netherlands
Poland
Spain
United States of America

Study participating centre

13794 NW 4th Street

Florida
33325
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2011	28/01/2019	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/01/2019: Publication reference added