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Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

COPD

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zofin
Placebo
Sponsored by
Organicell Regenerative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Zofin, Human Amniotic Fluid

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: Zofin

Group 2: Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Safety of Zofin
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.
Safety of Zofin
To monitor the frequency and severity of adverse events

Secondary Outcome Measures

FVC
FVC from resting PFT
FEV1
FEV1 from resting PFT
FEV1 to FVC ratio
FEV1 to FVC ratio on resting pulmonary function test
FEF25-75
FEF25-75 on resting pulmonary function test
Lung Volume Changes
Change in lung volumes (in body plethysmograph), including SGAW (specific airway conductance) and RV (to calculate gas trapping)
DLCO
Change in single breath diffusing capacity of lung for carbon monoxide (DLCO)
HU of CT Scan
Change in the average of Hounsfield Unit (HU) - a relative quantitative measurement of radio density in CT images.
% air in lung on CT Scan
Change in the percentage of air in the lung
CPET
Cardiopulmonary Exercise Testing (CPET) with peak VO2 and measures of dynamic hyperinflation
Peak VO2
Cardiopulmonary Exercise Testing (CPET) with peak VO2
Dynamic Hyperinflation
Cardiopulmonary Exercise Testing (CPET) with measures of dynamic hyperinflation
Pulmonary Exacerbation
Incidence of investigator-defined pulmonary exacerbation: decrease in exacerbation-related hospitalization
TNF-α
Change in serum inflammatory markers: TNF-α
CRP
Change in serum inflammatory markers: CRP
IL-1
Change in serum inflammatory markers: IL-1
D-Dimer
Change in serum inflammatory markers: D-dimer
Fibrinogen
Change in serum inflammatory markers: Fibrinogen
SF-36 ot SGRQ
Change in SF-36 questionnaire or St. George's Respiratory Questionnaire (SGRQ)
CAT Assessment
Change in quality of life (QOL) assessments via COPD Assessment Test (CAT)

Full Information

First Posted
November 1, 2022
Last Updated
March 21, 2023
Sponsor
Organicell Regenerative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05643729
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organicell Regenerative Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Zofin, Human Amniotic Fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The study will be double blinded such that neither the patients nor the researchers will know who is getting a placebo and who is getting the treatment. Only product manufacturing staff will be un-blinded.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Zofin
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zofin
Intervention Description
Intravenous Infusion (IV) of Zofin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intravenous Infusion of sterile saline
Primary Outcome Measure Information:
Title
Safety of Zofin
Description
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.
Time Frame
first 30 days
Title
Safety of Zofin
Description
To monitor the frequency and severity of adverse events
Time Frame
day 0 to 12 months
Secondary Outcome Measure Information:
Title
FVC
Description
FVC from resting PFT
Time Frame
Screen, day 4, day 8, 4 months, 8 months and 12 months
Title
FEV1
Description
FEV1 from resting PFT
Time Frame
Screen, day 4, day 8, 4 months, 8 months and 12 months
Title
FEV1 to FVC ratio
Description
FEV1 to FVC ratio on resting pulmonary function test
Time Frame
Screen, day 4, day 8, 4 months, 8 months and 12 months
Title
FEF25-75
Description
FEF25-75 on resting pulmonary function test
Time Frame
Screen, day 4, day 8, 4 months, 8 months and 12 months
Title
Lung Volume Changes
Description
Change in lung volumes (in body plethysmograph), including SGAW (specific airway conductance) and RV (to calculate gas trapping)
Time Frame
Screen, day 4, day 8, 4 months, 8 months and 12 months
Title
DLCO
Description
Change in single breath diffusing capacity of lung for carbon monoxide (DLCO)
Time Frame
Screen, day 4, day 8, 4 months, 8 months and 12 months
Title
HU of CT Scan
Description
Change in the average of Hounsfield Unit (HU) - a relative quantitative measurement of radio density in CT images.
Time Frame
Screen and 12 months
Title
% air in lung on CT Scan
Description
Change in the percentage of air in the lung
Time Frame
Screen and 12 months
Title
CPET
Description
Cardiopulmonary Exercise Testing (CPET) with peak VO2 and measures of dynamic hyperinflation
Time Frame
Screen, 4 months, and 12 months
Title
Peak VO2
Description
Cardiopulmonary Exercise Testing (CPET) with peak VO2
Time Frame
Screen, 4 months, and 12 months
Title
Dynamic Hyperinflation
Description
Cardiopulmonary Exercise Testing (CPET) with measures of dynamic hyperinflation
Time Frame
Screen, 4 months, and 12 months
Title
Pulmonary Exacerbation
Description
Incidence of investigator-defined pulmonary exacerbation: decrease in exacerbation-related hospitalization
Time Frame
Screening through 12 months
Title
TNF-α
Description
Change in serum inflammatory markers: TNF-α
Time Frame
Day 0, Day14, 4 months, 8 months, and 12 months
Title
CRP
Description
Change in serum inflammatory markers: CRP
Time Frame
Day 0, Day14, 4 months, 8 months, and 12 months
Title
IL-1
Description
Change in serum inflammatory markers: IL-1
Time Frame
Day 0, Day14, 4 months, 8 months, and 12 months
Title
D-Dimer
Description
Change in serum inflammatory markers: D-dimer
Time Frame
Day 0, Day14, 4 months, 8 months, and 12 months
Title
Fibrinogen
Description
Change in serum inflammatory markers: Fibrinogen
Time Frame
Day 0, Day14, 4 months, 8 months, and 12 months
Title
SF-36 ot SGRQ
Description
Change in SF-36 questionnaire or St. George's Respiratory Questionnaire (SGRQ)
Time Frame
Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months
Title
CAT Assessment
Description
Change in quality of life (QOL) assessments via COPD Assessment Test (CAT)
Time Frame
Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mari Mitrani, MD, PhD
Phone
(888) 963-7881
Email
clinicaltrials@organicell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Phrsai
Organizational Affiliation
Proxima
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Weidknecht, RN, MBA/HCM
Phone
480-342-3007
Email
Weidknecht.Jill@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)

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