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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
Awards & highlights

Study Summary

This trial evaluates the safety and effectiveness of IV Zofin for COPD. Double-blind, placebo-controlled.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of Zofin
Secondary outcome measures
% 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

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

Media Library

Zofin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05643729 — Phase 1 & 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Group 1: Zofin, Group 2: Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Zofin Highlights & Side Effects. Trial Name: NCT05643729 — Phase 1 & 2
Zofin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643729 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons aged 85 and below eligible for this experiment?

"Patients aged 40 to 80 are eligible for this trial. In contrast, there are 14 trials available for young people and 338 that target seniors."

Answered by AI

Are any additional volunteers being accepted for this trial?

"Clinicaltrials.gov confirms that this trial is currently searching for volunteers; the project was announced on December 18th 2022 and edited as recently as December 6th of the same year."

Answered by AI

How many individuals are currently enrolled in this research endeavor?

"Affirmative, clinicaltrials.gov indicates that this experiment is presently looking for subjects. It was initially posted on December 18th 2022 and the details have since been amended as recently as December 6th 2022. At present, 20 participants need to be recruited from one location."

Answered by AI

Could I potentially be included as a subject in this clinical research?

"This clinical trial is accepting 20 individuals between their fourth and eighth decades of life who are suffering from chronic obstructive airway disease. Candidates must provide informed consent, have an FEV1/FVC ratio below 0.7 and a RV/TLC ratio above 40%, not currently be consuming nicotine or having consumed it in the last six months, with a history of smoking at least 10 packs per year, oxyhemoglobin saturation on room air greater than 88%, adequate venous access for sample collection, and post-bronchodilator FEV1 percent predicted value <50%."

Answered by AI
~3 spots leftby May 2024