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)

Phase 2

Completed

• Conditions: Ischemic cardiomyopathy (heart failure); Circulatory System; Ischemic cardiomyopathy

• Registration Number: ISRCTN17181395
• Lead Sponsor: Bioheart Inc. (USA)

Brief Summary

1. 2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21982657 (added 28/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-10
• Study Completion: 2006-06-15
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified