Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

In the context of the proposed study, adipose derived stem cells (ASC) constitute an
autologous cell product that is delivered to the patient via intra-venous injection. In this
study, we propose to investigate the immunosuppressive potential of the non-manipulated
non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured
both by improvement of the forced evacuation volume in one second (FEV1) and distance
covered in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises
stromal cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not
cultured but are isolated from adipose tissue using a sterile tissue process in under two
hours. The process includes rinsing in a saline solution to remove red blood cells,
draining, and enzymatic digestion (collagenase) which isolates endothelial cells from
adipose tissue. Post-processing, the pellet obtained via centrifugation is filtered and
delivered to the patient who remains sedated within the same ambulatory center.

Inclusion Criteria:

- Age 18 to 85, inclusive

- A prior diagnosis of moderate to severe COPD

- GOLD IIa, III, IV

Exclusion Criteria:

- Pregnant or lactating

- Life expectancy < 6 months due to concomitant illnesses.

- Exposure to any investigational drug or procedure within 1 month prior to study entry
or enrolled in a concurrent study that may confound results of this study.

- Any illness which, in the Investigators judgment, will interfere with the patient's
ability to comply with the protocol, compromise patient safety, or interfere with the
interpretation of study results

- Subjects on chronic immunosuppressive or chemotherapeutic therapy

- Known drug or alcohol dependence or any other factors which will interfere with the
study conduct or interpretation of the results or who in the opinion of the
investigator are not suitable to participate.

- Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause
lung disease and liver disease).

- Unwilling and/or not able to give written consent

- Patient is positive for hepatitis (past history of Hepatitis A is allowed)

- Any medical condition, which in the opinion of the clinical investigator, would
interfere with the treatment or outcome of the patient

- Cerebral aneurysm clips