Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Organicell Regenerative Medicine

Criteria

Inclusion Criteria:

• Subject who can understand and are able to provide informed consent.

• Subject with moderate to severe COPD with normal cardiac, liver and renal function Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7

• Subject must have a post-bronchodilator FEV1 percent predicted value <50%

• Subject must have a RV/TLC ratio of > 40%

• Subject must be either a non-smoker or an ex-smoker, with a cigarette smoking history of ≥ 10 packs per year.

• Subject must have abstained from nicotine products for at least six months prior to enrollment in the study.

• Subject must be available for all specified assessments at the study site through the completion of the study.

• Subject must have oxyhemoglobin saturation on room air at rest equal or greater than 88% without oxygen

• Subject must be reasonably able to return for multiple follow-up visits.

• Adequate venous access

• For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment.

• Any male subject must agree to use contraceptives and not donate sperm during the study.

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.