Zofin for COPD

Overseen By Mari Mitrani, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ZEO ScientifiX, Inc.

Must not be taking: Immunosuppressives, Anticoagulants, Corticosteroids, others

Disqualifiers: Pulmonary disease, Malignancy, Autoimmune disorders, others

Compensation: Varies

Number of Visits: 18

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Zofin, a new potential treatment, is safe and effective for treating Chronic Obstructive Pulmonary Disease (COPD). Participants will receive either Zofin or a placebo, along with standard care, to assess whether Zofin can better manage COPD. The trial seeks individuals with moderate to severe COPD who have not smoked for at least six months but have a history of smoking. Eligible participants must attend all follow-up visits and complete the trial assessments. As a Phase 1 and Phase 2 trial, this research focuses on understanding how Zofin works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking COPD treatment research.

Will I have to stop taking my current medications?

The trial requires participants to stop taking prescription or over-the-counter pain medication for 7 days before any visit. If you are on immunosuppressive medications or anticoagulation therapy that cannot be stopped, you may not be eligible to participate.

Is there any evidence suggesting that Zofin is likely to be safe for humans?

Research has shown that Zofin, administered through an IV, has been tested for safety in people with conditions like COVID-19. In these studies, most participants tolerated Zofin well, with no serious side effects directly attributed to the treatment. This suggests that Zofin might be safe for humans. However, it is still under investigation for use in people with chronic obstructive pulmonary disease (COPD), making ongoing trials crucial to confirm its safety for this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Unlike the standard treatments for COPD, such as bronchodilators and corticosteroids, Zofin offers a fresh approach with its unique mechanism. Zofin is derived from extracellular vesicles, which have the potential to repair and regenerate damaged lung tissue. Researchers are excited about Zofin because it targets the underlying inflammation and tissue damage in COPD, which could lead to better lung function and improved quality of life for patients. Additionally, the treatment's administration through simple saline dilution makes it straightforward to deliver and potentially more accessible for widespread clinical use.

What evidence suggests that Zofin might be an effective treatment for COPD?

Research has shown that Zofin, which participants in this trial may receive, might help improve lung health. In an initial trial, patients who received Zofin had better lung scans and less inflammation. Another study found that 83% of patients had normal lung X-rays after treatment with Zofin. It has also been used in COVID-19 patients, where it helped reduce symptoms and improve breathing. These results suggest that Zofin could be promising for treating lung conditions like COPD. ^{6 7 8 9 10}

Who Is on the Research Team?

Natasha Phrsai

Principal Investigator

Proxima

Are You a Good Fit for This Trial?

Inclusion Criteria

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 who can understand and are able to provide informed consent.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive intravenous infusions of Zofin or placebo on Day 0, Day 4, and Day 8

1-2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual) at Day 14, 4 months, 8 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Zofin

How Is the Trial Designed?

Group I: Group 1: Zofin Experimental Treatment 1 Intervention

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 II: Group 2: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

ZEO ScientifiX, Inc.

Lead Sponsor

Trials

4

Recruited

60+

Organicell Regenerative Medicine

Lead Sponsor

Trials

4

Recruited

60+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8611818/

Proof-of-concept trial of an amniotic fluid-derived extracellular ...

Analysis of patient outcomes, including COVID-19-associated symptoms, chest x-ray images, and inflammatory biomarkers demonstrated the beneficial outcomes that ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05228899

NCT05228899 | Zofin to Treat COVID-19 Long Haulers

The purpose of this study is to assess the safety and potential efficacy of Zofin administered intravenously in subjects experiencing prolonged symptoms (> 6 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04657406

Expanded Access to Zofin for Patients With COVID-19

This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient facilities infected with SARS-CoV-2 who ...

4.

businesswire.com

businesswire.com/news/home/20210615005249/en/Organicell-Announces-Positive-Results-of-Their-Expanded-Access-Trial-for-the-Treatment-of-Mild-to-Moderate-COVID-19-Using-ZofinTM

Organicell Announces Positive Results of Their Expanded ...

... ZofinTM treatment. Thirty days after ZofinTM treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating ...

5.

delta.larvol.com

delta.larvol.com/Products/?ProductId=cbdc2c9b-e449-46cb-85a8-316429f1233c

Zofin (Organicell Flow) / Organicell

... Zofin™ in three severely ill COVID-19 patients. In these studies, results found the administration of Zofin™ to be associated with decreased levels of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8405236/

Treatment of a COVID-19 long hauler with an amniotic fluid ...

Zofin is an acellular biologic that contains the extracellular vesicle (EV) fraction of human amniotic fluid and is under investigation for use as a COVID-19 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05643729

Zofin to Treat Chronic Obstructive Pulmonary Disease ...

To demonstrate the safety of Zofin administered intravenously in subjects with COPD by measuring incidence of any of the following treatment-emergent serious ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05228899

NCT05228899 | Zofin to Treat COVID-19 Long Haulers

The purpose of this study is to assess the safety and potential efficacy of Zofin administered intravenously in subjects experiencing prolonged symptoms (> 6 ...

9.

claytonpp.com

claytonpp.com/wp-content/uploads/2019/04/Azofin-Plus-MSDS-Mar2019.docx.pdf

AZOFIN PLUS Safety Data Sheet according to Regulation ( ...

Physical and chemical hazards: The product is not flammable. In case of fire it may develop toxic and irritating fumes.

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666534421000246

Proof-of-concept trial of an amniotic fluid-derived ...

The completed study supports Zofin as a feasible, safe, and potentially efficacious therapy for patients with mild-to-moderate COVID-19 who are at increased ...