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

NCT00375817 | Unknown Phase 2 DMC

• 1 other identifier: BMI-EU-02-008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Infarction; Heart Failure, Congestive

Outcome Measures

Primary Outcomes (6)

• Overall Objective

• To assess the effect and safety of MyoCell™ therapy on myocardial function in congestive heart failure patients, post-myocardial infarction(s). Primary Safety Objective

• 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 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

• Primary MyoCellTM Efficacy Objective

• 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

Interventions

Myoblasts injection with MyoCath catheter PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioheart, Inc.: lead

Study Sites (1)

Richard Spencer

Sunrise, Florida, 33325, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jozef - Bartunek, MD

  Cardiovascular Center, Aalst

  PRINCIPAL INVESTIGATOR

• Anthony - Gershlick, MD

  Glenfield Hospital, University Hospitals of Leicester

  PRINCIPAL INVESTIGATOR

• Christoph - Hehrlein, MD

  University of Freiburg

  PRINCIPAL INVESTIGATOR

• Carlos - Macaya, MD

  Hospital Clinico San Carlos, Spain

  PRINCIPAL INVESTIGATOR

• Christoph - Nienaber, MD

  University, Rostock, Germany

  PRINCIPAL INVESTIGATOR

• Nicholas - Peters, MD

  St Mary's Hospital & Imperial College, London

  PRINCIPAL INVESTIGATOR

• Joachim - Schofer, MD

  Universitaires Herzzentrum Hamburg, Germany

  PRINCIPAL INVESTIGATOR

• Patrick - Serruys, MD

  Thorax Centre-Erasmus University, The Netherlands

  STUDY CHAIR

• Tomasz - Siminiak, MD

  Cardiac & Rehabilitation Hospital at Kowanowko,Poland

  PRINCIPAL INVESTIGATOR

• Peter - Smits, MD

  Medisch Centrum, Rijnmond Zuid, The Netherlands

  PRINCIPAL INVESTIGATOR

• J. - Waltenberger, MD

  Academisch Ziekenhuis Maastrict, The Netherlands

  PRINCIPAL INVESTIGATOR

• Walter Van Mieghem, MD

  ZOL Campus St. Jan, Genk, Belgium

  PRINCIPAL INVESTIGATOR

• Victor Legrand, MD

  University Hospital, Liege, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 13, 2006
• Study Start: November 1, 2005
• Study Completion: January 1, 2008
• Last Updated: October 12, 2007

Record last verified: 2007-10

Locations

US (1)