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Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
ZEO ScientifiX, Inc.Lead Sponsor
3 Previous Clinical Trials
38 Total Patients Enrolled
Organicell Regenerative MedicineLead Sponsor
3 Previous Clinical Trials
38 Total Patients Enrolled
Natasha PhrsaiStudy DirectorProxima
1 Previous Clinical Trials
18 Total Patients Enrolled
Kristen BoylenStudy DirectorProxima
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a non-smoker or used to smoke and have a history of smoking at least 10 packs of cigarettes per year.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Zofin
- Group 2: Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.