Condition category
Circulatory System
Date applied
01/03/2006
Date assigned
10/03/2006
Last edited
18/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bioheartinc.com

Contact information

Type

Scientific

Primary contact

Mr Richard Spencer

ORCID ID

Contact details

13794 NW 4th Street
Suite 212
Sunrise
Florida
33325
United States of America
+1 954 835 1500

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00375817

Protocol/serial number

BMI-EU-02-008

Study information

Scientific title

Acronym

SEISMIC

Study hypothesis

Is MyoCell™ treatment effective for improving patient’s cardiac function? (where cardiac function is assessed by a series of measurements indicating improvement or degradation of patient’s cardiovascular function, exercise capacity, frequency of hospitalizations (both positive and negative), the length of stay, mechanical function and functional status)

Ethics approval

Approved by the West Essex Local Research Ethics Committee (UK), 06/01/2006, reference number: 05/Q0301/46

Study design

Open-label, randomized, multicenter study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ischemic cardiomyopathy (heart failure)

Intervention

Cell delivery via needle injection catheter versus standard medical therapy

Intervention type

Drug

Phase

Phase II

Drug names

MyoCell

Primary outcome measures

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).

Secondary outcome measures

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

Overall trial start date

15/03/2006

Overall trial end date

15/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46 (30 treatment, 16 control)

Participant exclusion criteria

1. Myocardial infarction within 90 days of the patient’s 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 patient’s 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 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
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.

Recruitment start date

15/03/2006

Recruitment end date

15/06/2006

Locations

Countries of recruitment

Belgium, Germany, Netherlands, Poland, Spain, United Kingdom

Trial participating centre

13794 NW 4th Street
Florida
33325
United States of America

Sponsor information

Organisation

Bioheart Inc. (USA)

Sponsor details

13794 NW 4th street
Suite 212
Sunrise
Florida
33325
United States of America
+1 954 835 1500

Sponsor type

Industry

Website

http://www.bioheartinc.com

Funders

Funder type

Industry

Funder name

Bioheart Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes