Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD

STUDY DESIGN This is a Phase I open- label single-dose study in subjects with significant
COPD. This is an expanded safety cohort. The investigators will enroll a minimum of 30
subjects. 6 week data of FEV1, FEV1/FVC, DLCO and 6 min walking distance values will be
collected in all patients who are enrolled in the study (Baseline and 6 weeks after). Prior
to the stem cell treatment, the patient will be assessed for 6 weeks by pulmonary function
tests and 6 min walk tests. Then, patients will receive the infusion of stromal vascular
fraction cells containing the aADSC (single intravenous dose). The standard therapy of COPD
patients will not be interrupted during the duration of the study. Safety will be monitored
on an ongoing basis, and an interim safety review will be conducted by the Investigator(s)
and Sponsor after the first 20 patients have been enrolled and treated.

Inclusion Criteria:

1. Males and Females ≥18 years.

2. Cognitive competitiveness.

3. Diagnosis of at least moderate COPD (postbronchodilator FEV1/FVC < 70% (<0.7), FEV1 <
80% predicted).

4. Diffusing capacity impairment (DLCO) assessed by single breath test (corrected for
alveolar volume, 'DLVA').

5. Life expectancy greater than 12 months.

6. Ability to understand and provide signed informed consent, or have a designated legal
guardian or spouse legally able and willing to make such decisions on the subject's
behalf.

7. Reasonable expectation that patient will receive standard post-treatment care and
attend all scheduled safety follow-up visits.

8. No changes in active pulmonary medications for heart failure during the two weeks
prior enrollment.

10. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more
history

Exclusion Criteria:

1. Current smokers.

2. Unstable coronary disease.

3. Patients with industrial exposure to silica and/or asbestos or giant bullae.

4. Uncontrolled seizure disorder.

5. Dementia.

6. Presence of immune deficiency or autoimmune disease.

7. Alpha- 1 antitrypsin deficiency.

8. Cor pulmonale or diastolic heart failure NYHA class III or IV

9. Type 1 diabetes mellitus

10. Complicated type 2 diabetes mellitus.

11. Active tuberculosis or severe lung damage due to tuberculosis (extensive cavitation).

12. History of cancer within the past 5 years.

13. Clinically-significant hematologic, hepatic, or renal impairment as determined by
screening clinical laboratory tests.

14. Systemic corticosteroids, cytostatics, immunosuppressive drug therapy
(cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting
or cytotoxic drugs taken within four weeks prior to study treatment.

15. Porphyria.

16. Allergy to sodium citrate or any "caine" type of local anesthetic.

17. Abnormal findings could include: known HIV infection or other immunodeficiency state,
chronic active viral infection (such as hepatitis B or C), acute systemic infections
(defined as patients undergoing treatment with antibiotics), gastrointestinal tract
bleeding, or any severe or acute concomitant illness or injury.