The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial.

A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of
Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC
and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and
Heart Failure Secondary to Myocardial Infarction.

A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized
phase.

Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI
scheduled to undergo cardiac catheterization.

Inclusion Criteria:

- In order to participate in this study, a patient MUST:

1. Be ≥ 21 and < 90 years of age.

2. Provide written informed consent.

3. Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to
myocardial infarction (MI) as defined by the following: Screening MRI must show
an area of akinesis, dyskinesis, or severe hypokinesis associated with evidence
of myocardial scarring based on delayed hyperenhancement following gadolinium
infusion.

4. Been treated with appropriate maximal medical therapy for heart failure or
post-infarction left ventricular dysfunction. For beta-blockade, the patient must
have been on a stable dose of a clinically appropriate beta-blocker for 3 months.
For angiotensin-converting enzyme inhibition, the patient must have been on a
stable dose of a clinically appropriate agent for 1 month.

5. Be a candidate for cardiac catheterization.

6. Have an ejection fraction ≤ 50% by gated blood pool scan, two-dimensional
echocardiogram, cardiac MRI, or left ventriculogram within the prior six months
and not in the setting of a recent ischemic event.

Exclusion Criteria:

- In order to participate in this study, a patient MUST NOT:

1. Have a baseline glomerular filtration rate < 50 ml/min1.73m2.

2. Have a known, serious radiographic contrast allergy.

3. Have a mechanical aortic valve or heart constrictive device.

4. Have a documented presence of aortic stenosis (aortic stenosis graded as ≥ +2
equivalent to an orifice area of 1.5cm2 or less).

5. Have a documented presence of moderate to severe aortic insufficiency
(echocardiographic assessment of aortic insufficiency graded as ≥+2).

6. Require coronary artery revascularization. Patients who require or undergo
revascularization procedures should undergo these procedures a minimum of 3
months in advance of treatment within this study. In addition, patients who
develop a need for revascularization following enrollment will be submitted for
this therapy without delay.

7. Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥
20 consecutive beats or complete heart block) or QTc interval > 550 ms on
screening ECG.

8. AICD firing in the past 60 days prior to the procedure.

9. Have unstable angina within 2 weeks of the planned procedure.

10. Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell
< 2,500/ul or platelet values < 100,000/ul without another explanation.

11. Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three
times the ULN.

12. Have a coagulopathy = (INR > 1.3) not due to a reversible cause (i.e., Coumadin).
Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed
to have an INR < 1.3. Patients who cannot be withdrawn from Coumadin will be
excluded from enrollment

13. Have known allergies to penicillin or streptomycin.

14. Have a contra-indication to performance of an MRI scan.

15. Be an organ transplant recipient.

16. Have a clinical history of malignancy within 5 years (i.e., patients with prior
malignancy must be disease free for 5 years), except curatively-treated basal
cell carcinoma, squamous cell carcinoma, or cervical carcinoma.

17. Have a non-cardiac condition that limits lifespan to < 1 year.

18. Have a history of drug or alcohol abuse within the past 24 months.

19. Be on chronic therapy with immunosuppressant medication, such as corticosteroids
or TNFα antagonists.

20. Be serum positive for HIV, hepatitis BsAg or hepatitis C.

21. Be currently participating (or participated within the previous 30 days) in an
investigational therapeutic or device trial.

22. Be a female who is pregnant, nursing, or of childbearing potential while not
practicing effective contraceptive methods. Female patients must undergo a blood
or urine pregnancy test at screening and within 36 hours prior to injection.