Zofin to Treat Chronic Obstructive Pulmonary Disease (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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing an IV treatment called Zofin for people aged 40 to 80 who have COPD. The goal is to see if Zofin can help their lungs work better and make it easier for them to breathe. Participants will receive either Zofin or another treatment and be monitored over time to check the treatment's safety and effectiveness.

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.

Research Team

Natasha Phrsai

Principal Investigator

Proxima

Eligibility Criteria

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

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

Treatment Details

Interventions

• Zofin

Participant Groups

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+