Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System

Given the limited treatment options available to patients with congestive heart failure,
there is a need for alternative therapies. Autologous skeletal myoblast transplantation has
been demonstrated in pre-clinical studies to be a safe and effective treatment of heart
failure. Initial clinical studies have shown that autologous myoblasts can be delivered into
infracted myocardium by both direct epicardial and endomyocardial injection. However,
autologous skeletal myoblast transplantation via percutaneous endomyocardial injection has
the potential to play a significant role in such congestive heart failure patients without
the need for surgical risk and general anesthesia. Thus, a Phase 2 clinical trial is
proposed in order to evaluate the effectiveness of autologous myoblast delivered by
endomyocardial injection for the treatment congestive heart failure.

Inclusion Criteria:

1. Subjects with ischemic cardiomyopathy and previous myocardial infarction

2. New York Heart Association Classification III - ambulatory Class IV

3. Ejection fraction < 35% as determined by any method at baseline evaluation

4. Subjects could be considered for enrollment if CRT placement has occurred greater
than three months previously with no clinical improvement, CRT settings are judged to
be optimized and the subject continues to meet all other inclusion criteria
(inadequate-responders).

5. Documentation of ineligibility for coronary revascularization and/or valve repair/
replacement by review of recent left heart catheterization (within six months of
baseline).

6. Receiving optimally tolerated doses of standard, stable pharmacotherapy, including
angiotensin-converting enzyme inhibitors, unless intolerant or contra-indicated,
diuretics, ß-receptor blockers for at least one month prior to enrollment

7. Severe myocardial perfusion abnormality documented by SPECT imaging, involving at
least 1/3 of a vascular territory, as confirmed by core lab.

Exclusion Criteria:

1. Age < 21 years or > 75 years.

2. Significant coronary stenosis, as determined by the Investigator, which may
potentially require percutaneous or surgical revascularization within 12 weeks of
enrollment.

3. Recent (within 4 weeks), documented acute coronary syndrome, i.e. (Q wave or non-Q
wave infarction) or hospitalization for unstable angina.

4. Documented cerebrovascular accident (stroke) or TIA within 60 days.

5. Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or
echocardiography.

6. Clinically significant electrocardiographic abnormalities that may interfere with
subject safety during the intracardiac mapping and injection procedure. Patients with
right bundle branch block with basal septal infarction.

7. Subjects with CRT placement within three months of enrollment or intent to insert
CRT, or CRT settings not judged to be optimized

8. High grade atrioventricular block not corrected by permanent pacemaker or ICD.

9. Frequent or recurrent, ventricular tachycardia in absence of an ICD.

10. Atrial fibrillation with uncontrolled ventricular response

11. Significant uncorrected valvular disease, which results in additional hemodynamic
compromise and/or would require valvular repair or replacement. Patients with severe
aortic stenosis or status-post mitral or aortic mechanical valve replacement.

12. Severe peripheral vascular disease, such that femoral access would be prohibited.

13. INR > 1.5 in absence of coumadin or partial thromboplastin time (PTT) >20% above ULN,
or thrombocytopenia (platelet count < 75,000).

14. Significant renal dysfunction (e.g., creatinine >2.5 mg/dL) or liver disease (e.g.,
serum glutamic-oxaloacetic transaminases / aspartate aminotransferase SGOT/AST or
serum glutamic-pyruvic transaminases/alanine aminotransferase SGPT/ALT > 4 x upper
limit of normal [ULN]).

15. Currently enrolled, or have been enrolled within 30 days, in another investigational
drug or device study that has not completed the protocol required follow-up period.

16. Subjects who have received a prior investigational stem cell or angiogenic agent.

17. Subjects who have tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B
Virus (HBV), and/or Hepatitis C Virus (HCV).

18. History of skeletal muscle disease, e.g. family history of acute or chronic skeletal
muscle disease including infectious, drug-induced, familial, autoimmune and
idiopathic myopathies.

19. Creatine phosphokinase (CK) or lactate dehydrogenase elevated greater than three
times normal or unexplained elevations of CK.

20. Female subjects who are pregnant or nursing or any subject with reproductive
capabilities unwilling to use effective birth control for the duration of the study
period.

21. Evidence of concurrent infection of any type (e.g. Elevated white blood cell count
{WBC>13,000}, temperature of >38.5 C, or infiltrate on chest x-ray).

22. Any other major illness, which, in the Investigator's judgment, will interfere with
the subject's ability to comply with the protocol, compromises subject safety, or
interferes with the interpretation of the study results.

23. Idiopathic Cardiomyopathy, hypertrophic cardiomyopathy

24. Subjects with ventricular wall thickness in the infarct zone of < 5 mm measured by
echocardiogram at baseline.

25. Patients on chronic (or chronic intermittent) IV inotropic medication. -