ClinicalTrials.gov

History of Changes for Study: NCT05643729
Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
Latest version (submitted October 30, 2023) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 December 6, 2022 None (earliest Version on record)
2 February 20, 2023 Study Status, Contacts/Locations and Eligibility
3 March 21, 2023 Study Status
4 October 30, 2023 Recruitment Status, Study Status and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Study NCT05643729
Submitted Date:  December 6, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 27198
Brief Title: 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)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2022
Overall Status: Recruiting
Study Start: December 18, 2022
Primary Completion: May 30, 2024 [Anticipated]
Study Completion: August 31, 2024 [Anticipated]
First Submitted: November 1, 2022
First Submitted that
Met QC Criteria:
December 6, 2022
First Posted: December 9, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
December 6, 2022
Last Update Posted: December 9, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ZEO ScientifiX, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: COPD
Keywords: Zofin
Human Amniotic Fluid
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
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.
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1: Zofin
Group 1 Treatment Arm (10 subjects): Zofin + Standard of care (SOC) Ten subjects will receive 1 mL of Zofin on Day 0, Day 4, and Day 8, containing 1-5 x 10^11 particles/ml. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside. In addition to Zofin all subjects in this trial will receive SOC throughout the study period.
Drug: Zofin
Intravenous Infusion (IV) of Zofin
Placebo Comparator: Group 2: Placebo
Group 2 Control Arm (10 subjects): Placebo + SOC Ten subjects will receive placebo on Day 0, Day 4, and Day 8, containing 101 mL of sterile saline at subject's bedside. In addition to placebo all subjects in this trial will receive SOC throughout the study period.
Placebo
Intravenous Infusion of sterile saline
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety of Zofin
[ Time Frame: first 30 days ]

To demonstrate the safety of Zofin administered intravenously in subjects with COPD by measuring incidence of any of the following treatment-emergent serious adverse events (TE-SAEs) within the first 30 days of infusion:

  • Life-threatening event (e.g., stroke or non-fatal pulmonary embolism).
  • Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea).
  • Event resulting in persistent or significant disability/incapacity.
  • Event resulting in death. Frequency and severity of any adverse events from Day 0 (day of treatment) up to 12 months of treatment will similarly be observed.
2. Safety of Zofin
[ Time Frame: day 0 to 12 months ]

To monitor the frequency and severity of adverse events
Secondary Outcome Measures:
1. FVC
[ Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months ]

FVC from resting PFT
2. FEV1
[ Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months ]

FEV1 from resting PFT
3. FEV1 to FVC ratio
[ Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months ]

FEV1 to FVC ratio on resting pulmonary function test
4. FEF25-75
[ Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months ]

FEF25-75 on resting pulmonary function test
5. Lung Volume Changes
[ Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months ]

Change in lung volumes (in body plethysmograph), including SGAW (specific airway conductance) and RV (to calculate gas trapping)
6. DLCO
[ Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months ]

Change in single breath diffusing capacity of lung for carbon monoxide (DLCO)
7. HU of CT Scan
[ Time Frame: Screen and 12 months ]

Change in the average of Hounsfield Unit (HU) - a relative quantitative measurement of radio density in CT images.
8. % air in lung on CT Scan
[ Time Frame: Screen and 12 months ]

Change in the percentage of air in the lung
9. CPET
[ Time Frame: Screen, 4 months, and 12 months ]

Cardiopulmonary Exercise Testing (CPET) with peak VO2 and measures of dynamic hyperinflation
10. Peak VO2
[ Time Frame: Screen, 4 months, and 12 months ]

Cardiopulmonary Exercise Testing (CPET) with peak VO2
11. Dynamic Hyperinflation
[ Time Frame: Screen, 4 months, and 12 months ]

Cardiopulmonary Exercise Testing (CPET) with measures of dynamic hyperinflation
12. Pulmonary Exacerbation
[ Time Frame: Screening through 12 months ]

Incidence of investigator-defined pulmonary exacerbation: decrease in exacerbation-related hospitalization
13. TNF-α
[ Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months ]

Change in serum inflammatory markers: TNF-α
14. CRP
[ Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months ]

Change in serum inflammatory markers: CRP
15. IL-1
[ Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months ]

Change in serum inflammatory markers: IL-1
16. D-Dimer
[ Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months ]

Change in serum inflammatory markers: D-dimer
17. Fibrinogen
[ Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months ]

Change in serum inflammatory markers: Fibrinogen
18. SF-36 ot SGRQ
[ Time Frame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months ]

Change in SF-36 questionnaire or St. George's Respiratory Questionnaire (SGRQ)
19. CAT Assessment
[ Time Frame: Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months ]

Change in quality of life (QOL) assessments via COPD Assessment Test (CAT)
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Mari Mitrani, MD, PhD
Telephone: (888) 963-7881
Email: clinicaltrials@organicell.com
Study Officials: Kristen Boylen
Study Director
Proxima
Locations: United States, Arizona
Mayo Clinic
[Recruiting]
Phoenix, Arizona, United States, 85054
Contact:Contact: Jill Weidknecht, RN, MBA/HCM 480-342-3007 Weidknecht.Jill@mayo.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services