Group 1: Zofin for Chronic Obstructive Pulmonary Disease

Phase 1 & 2

Waitlist Available

Research Sponsored by ZEO ScientifiX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screen, 4 months, and 12 months

Summary

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.

Eligible Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screen, 4 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screen, 4 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and screen, 4 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of Zofin

Secondary study objectives

% air in lung on CT Scan

CAT Assessment

CPET

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: ZofinExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zofin

2022

Completed Phase 2

~40

Do I qualify?Apply below to find out