RecruitingPhase 1NCT06986070

Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD).

A Phase 1, First-in-Human, Clinical Trial to Evaluate the Safety of Small Mobile Stem Cells (SMS) Delivered Into the Lung as a Potential Organ Regeneration Therapy in Chronic Obstructive Pulmonary Disease (SORT-COPD Study

Sponsor

SMSbiotech

Enrollment

18 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Lung Disease

Summary

This study is a phase 1, first-in-human, open-label, non-randomized, dose escalation safety study of 18 participants, between 39 and 69 years of age, with mild to moderate chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells). The primary objective of this study is to determine the safety of SORT-COPD (SMS cells) at three doses in people with chronic obstructive pulmonary disease.

Eligibility

Min Age: 39 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating a new treatment approach using a person's own small mobile stem cells (SMS cells) to see if they can help repair or slow the progression of COPD (chronic obstructive pulmonary disease), a long-term lung condition that makes it hard to breathe. **You may be eligible if...** - You are 39–69 years old - You have a diagnosis of COPD - You are not pregnant or breastfeeding, and are using adequate contraception if you are of childbearing potential **You may NOT be eligible if...** - You are outside the age range - You are pregnant or breastfeeding - You do not meet the study's health requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALStem cells

The suspension of stem cells will be put in a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. This means that the participants will breathe in the mist containing the SMS cells, produced by the nebulizer machine. This is a Phase I First-in-Human study, which indicates that this treatment is being studied for the first time in humans.

Locations(2)

Veritus Research

Bayswater, Victoria, Australia

Doherty Clinical Trials Limited

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06986070

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