Clinical trial NCT05643729: Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: COPD
Keywords: Zofin
Human Amniotic Fluid
Lead sponsor: ZEO ScientifiX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase I/II randomized, double blinded and placebo control. The ratio between groups is 1:1 for total 20 subjects. Each subject will be randomized to receive either treatment or placebo.
Primary purpose: TREATMENT

Brief 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).

Detailed description: Total of 20 adult patients will be chosen from population of adults between the age of 40 to 80 diagnosed with COPD to be randomized to 1 of 2 treatment arms including IV infusion of Zofin or IV infusion on sterile saline.

The subjects will be followed for 12 months to demonstrate safety and efficacy of Zofin.

Eligibility 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.

Primary outcomes:
measure: Safety of Zofin
timeFrame: first 30 days
measure: Safety of Zofin
timeFrame: day 0 to 12 months
Secondary outcomes:
measure: FVC
timeFrame: Screen, day 4, day 8, 4 months, 8 months and 12 months
measure: FEV1
timeFrame: Screen, day 4, day 8, 4 months, 8 months and 12 months
measure: FEV1 to FVC ratio
timeFrame: Screen, day 4, day 8, 4 months, 8 months and 12 months
measure: FEF25-75
timeFrame: Screen, day 4, day 8, 4 months, 8 months and 12 months
measure: Lung Volume Changes
timeFrame: Screen, day 4, day 8, 4 months, 8 months and 12 months
measure: DLCO
timeFrame: Screen, day 4, day 8, 4 months, 8 months and 12 months
measure: HU of CT Scan
timeFrame: Screen and 12 months
measure: % air in lung on CT Scan
timeFrame: Screen and 12 months
measure: CPET
timeFrame: Screen, 4 months, and 12 months
measure: Peak VO2
timeFrame: Screen, 4 months, and 12 months
measure: Dynamic Hyperinflation
timeFrame: Screen, 4 months, and 12 months
measure: Pulmonary Exacerbation
timeFrame: Screening through 12 months
measure: TNF-α
timeFrame: Day 0, Day14, 4 months, 8 months, and 12 months
measure: CRP
timeFrame: Day 0, Day14, 4 months, 8 months, and 12 months
measure: IL-1
timeFrame: Day 0, Day14, 4 months, 8 months, and 12 months
measure: D-Dimer
timeFrame: Day 0, Day14, 4 months, 8 months, and 12 months
measure: Fibrinogen
timeFrame: Day 0, Day14, 4 months, 8 months, and 12 months
measure: SF-36 ot SGRQ
timeFrame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
measure: CAT Assessment
timeFrame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Proxima
name: Natasha Phrsai
role: STUDY_DIRECTOR
References: