Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)

Eligible subjects will undergo sequential intracoronary infusion of CAP-1002 or placebo in
up to three coronary arteries supplying three major cardiac territories to the heart
(anterior, lateral, inferior/posterior). After completion of the screening procedures, Phase
Ia subjects will receive CAP-1002 administered via intracoronary infusion in a dose
escalation, stepwise manner. Phase Ia subjects will be followed at Week 2 and at Months 1,
2, 3, 6 and 12 after CAP-1002 infusion. The first fourteen (14) subjects will receive
intracoronary infusion of CAP-1002 in an open-label fashion (Phase Ia). Once all 14 subjects
in the Phase Ia have reached the primary safety endpoint (1 month visit), the DSMB will
conduct a review of the Phase Ia data and recommend whether to proceed with enrollment of
the next 28 subjects in the Phase Ib.

Major Inclusion Criteria:

1. DCM with left ventricular ejection fraction (LVEF) ≤ 35% as determined by a
historical TTE within the previous 6 months

2. New York Heart Association (NYHA) Class III or ambulatory Class IV heart failure

3. Use of evidence based medical-therapy (beta-blockers, ACE-inhibitors/angiotensin
receptor blockers, aldosterone antagonist) and with or without device-therapy
(Implantable cardioverter-defibrillator or cardiac resynchronizing therapy), in
accordance with the ACC/AHA guidelines for the management of heart failure, for at
least three months prior to enrollment or documented contraindication or intolerance
or patient preference

4. Coronary anatomy suitable for Investigational Product (IP) infusion, as determined by
the Eligibility Committee (a team of cardiology experts)

5. Ability to provide informed consent and follow-up with protocol procedures

6. Screening cardiac CT left ventriculogram ejection fraction <40% with left ventricular
dilatation

7. Age > 18 years

Major Exclusion Criteria:

1. Diagnosis of active myocarditis

2. Immunologic incompatibility with all available Master Cell Banks (MCBs) by
single-antigen bead (SAB) serum antibody profiling

3. Left Ventricular Assist Devices (LVAD) or those actively in the process of acquiring
one

4. Recent placement of a cardiac pacemaker and/or resynchronization pacing therapy
within the past three months or those actively in the process of acquiring one

5. History of sustained ventricular tachycardia (VT) requiring cardiopulmonary
resuscitation (with the exception of subjects who subsequently received an ICD)

6. Non-cardiovascular disease with life expectancy of < 3 years

7. Known hypersensitivity to contrast agents

8. Estimated glomerular filtration rate (GFR) < 50 mL/min

9. Active infection not responsive to treatment

10. Active allergic reactions, connective tissue disease or autoimmune disorders

11. History of cardiac tumor, or cardiac tumor demonstrated on screening

12. History of previous stem cell therapy

13. History of treatment with immunosuppressive agents, including chronic systemic
corticosteroids, biologic agents targeting the immune system, anti-tumor and
anti-neoplastic drugs or anti-vascular endothelial growth factor (VEGF) within 6
months prior to enrollment (not including drug eluting coronary stents)

14. History of receipt of chemotherapeutic agents known to be implicated in cardiac
dysfunction [Adriamycin, trastuzumab (Herceptin)]

15. Known moderate-severe aortic stenosis/insufficiency or severe mitral
stenosis/regurgitation

16. Participation in an on-going protocol studying an experimental drug or device

17. Current active alcohol or drug abuse or inability to comply with protocol-related
procedures

18. Pregnant/nursing women and women of child-bearing potential without use of active and
highly reliable contraception

19. Known history of Human Immunodeficiency Virus (HIV) infection

20. Known history of chronic viral hepatitis

21. Abnormal liver function (serum glutamic pyruvic transaminase (SGPT) > 10 times the
upper reference range) and/or abnormal hematology (hematocrit < 25%, white blood
cells (WBC) < 3000 µl, platelets < 100,000 µl) studies without a reversible,
identifiable cause

22. Evidence of tumor on screening of chest/abdominal/pelvic (body) CT scan

23. Any prior organ transplant;

24. Being actively listed for, or under active consideration (i.e., work-up) for, a
solid organ transplant of any kind;

25. Known hypersensitivity to bovine products;

26. Known hypersensitivity to dimethyl sulfoxide (DMSO);

27. Any malignancy within past 2 years (except for in-situ non-melanoma skin cancer and
in-situ cervical cancer);

28. Any prior radiation therapy/treatment to the chest;

29. Uncontrolled diabetes (HbA1 >9.0);

30. Any condition or other reason that, in the opinion of the Investigator or Medical
Monitor, would render the subject unsuitable for the study.