Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)

Exclusion Criteria

• •Subject with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the infusion or complete the study
• •* Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
• •* Subject has been diagnosed with a pulmonary disease other than COPD (e.g. asthma, pulmonary, fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease)
• •* Subject has been diagnosed with α1-Antitrypsin deficiency
• •* Subject has a body mass index greater than 42 kg/m2
• •* Subject has or had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
• •* Subject has or had exacerbation of COPD requiring hospitalization within 12 weeks of enrollment in the study.
• •* Subject has initiated pulmonary rehabilitation within 12 weeks of enrollment in the study
• •* Subject uses or used prednisone (or equivalent dose of another corticosteroid) within 12 weeks of enrollment in the study
• •* Subject has evidence or history of malignancy
• •* Subject has evidence or history of autoimmune disorders independent of COPD
• •* Subject is pregnant or breast-feeding
• •* Subject with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. Subject with clinically significant bronchiectasis.
• •* Subject received an experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment.
• •* Subject is unable to complete all the testing required for the study
• •* Subject who is on immunosuppressive medications.
• •* Subject who is unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit.
• •* Subject with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to infusion.
• •* Active listing (or expected future listing) for transplant of any organ.
• •* Be a solid organ transplant recipient. This does not include prior cell-based therapy (\>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
• •* History of drug abuse (illegal "street" drugs) except noninhalation use of marijuana (If it is legal use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs withinthe past 24 months. Use of inhalation marijuana will be an exclusion criterion.
• •* Subject with untreated HIV infection. However, patients can be enrolled if they have been treated for HIV and test negative for HIV viral load but still test positive for antibodies.