- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05643729
Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
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 Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Mari Mitrani, MD, PhD
- Phone Number: (888) 963-7881
- Email: clinicaltrials@organicell.com
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85054
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Intravenous Infusion of sterile saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
first 30 days
|
Safety of Zofin
Time Frame: day 0 to 12 months
|
To monitor the frequency and severity of adverse events
|
day 0 to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FVC
Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
|
FVC from resting PFT
|
Screen, day 4, day 8, 4 months, 8 months and 12 months
|
FEV1
Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
|
FEV1 from resting PFT
|
Screen, day 4, day 8, 4 months, 8 months and 12 months
|
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
|
Screen, day 4, day 8, 4 months, 8 months and 12 months
|
FEF25-75
Time Frame: Screen, day 4, day 8, 4 months, 8 months and 12 months
|
FEF25-75 on resting pulmonary function test
|
Screen, day 4, day 8, 4 months, 8 months and 12 months
|
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)
|
Screen, day 4, day 8, 4 months, 8 months and 12 months
|
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)
|
Screen, day 4, day 8, 4 months, 8 months and 12 months
|
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.
|
Screen and 12 months
|
% air in lung on CT Scan
Time Frame: Screen and 12 months
|
Change in the percentage of air in the lung
|
Screen and 12 months
|
CPET
Time Frame: Screen, 4 months, and 12 months
|
Cardiopulmonary Exercise Testing (CPET) with peak VO2 and measures of dynamic hyperinflation
|
Screen, 4 months, and 12 months
|
Peak VO2
Time Frame: Screen, 4 months, and 12 months
|
Cardiopulmonary Exercise Testing (CPET) with peak VO2
|
Screen, 4 months, and 12 months
|
Dynamic Hyperinflation
Time Frame: Screen, 4 months, and 12 months
|
Cardiopulmonary Exercise Testing (CPET) with measures of dynamic hyperinflation
|
Screen, 4 months, and 12 months
|
Pulmonary Exacerbation
Time Frame: Screening through 12 months
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Incidence of investigator-defined pulmonary exacerbation: decrease in exacerbation-related hospitalization
|
Screening through 12 months
|
TNF-α
Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months
|
Change in serum inflammatory markers: TNF-α
|
Day 0, Day14, 4 months, 8 months, and 12 months
|
CRP
Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months
|
Change in serum inflammatory markers: CRP
|
Day 0, Day14, 4 months, 8 months, and 12 months
|
IL-1
Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months
|
Change in serum inflammatory markers: IL-1
|
Day 0, Day14, 4 months, 8 months, and 12 months
|
D-Dimer
Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months
|
Change in serum inflammatory markers: D-dimer
|
Day 0, Day14, 4 months, 8 months, and 12 months
|
Fibrinogen
Time Frame: Day 0, Day14, 4 months, 8 months, and 12 months
|
Change in serum inflammatory markers: Fibrinogen
|
Day 0, Day14, 4 months, 8 months, and 12 months
|
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)
|
Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
|
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)
|
Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Natasha Phrsai, Proxima
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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