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

Primary Purpose

Myocardial Infarction, Heart Failure, Congestive

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Myoblasts injection with MyoCath catheter

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Richard Spencer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00375817

First Posted

September 11, 2006

Last Updated

October 11, 2007

Sponsor

Bioheart, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00375817

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

November 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bioheart, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Heart Failure, Congestive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Myoblasts injection with MyoCath catheter

Primary Outcome Measure Information:

Title

Overall Objective

Title

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

Title

The primary safety objective defined for this study is as follows:

Title

Primary MyoCellTM Efficacy Objective

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: