NCT06986070

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: SMSbiotech · Industry
• Sex: All
• Age: 39 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 18 participants are expected to be enrolled into this study. Participants will be divided into three groups of six volunteers, with the first group receiving the lowest dose of the study treatment, the second group receiving a higher dose, and the third group receiving the highest dose. Between each of the three groups, there will be a pause to permit detection of any short-term adverse effects of the treatment at a specific dose. Participants will be treated with the study drug, SORT COPD (Small Mobile Stem Cells), delivered via a medical nebuliser on the 1st, 4th, and the 8th days of the study in-clinic. The nebuliser treatment involves inhaling mist from a mouthpiece attached to a standard medical nebuliser machine and takes about 10 to 15 minutes to complete. The volume to be nebulised is 3 millilitres (less than one teaspoon). Participants in the cohort 1 (low dose) will receive 1.2 billion cells/ml. Participants in the cohort 2 (medium dose) will receive 2.4 billion cells/ml. Participants in the cohort 3 (high dose) will receive 4.8 billion cells/ml. The study treatment (SMS) cells will be given in three different concentrations with the lowest dose given to the 1st group of 6 participants, with the dose doubled for each group. The members of each group will receive the same dose at each treatment visit. Participants will actively be in the study for up to 5 or 6 weeks, including the initial screening and testing period before the treatment is applied, during treatment, and about 4 weeks after the first treatment. Also, about 3 to 6 months after the study, participants will be contacted via telephone to answer some questions about their state of health, which will be the end of the study. Individual participant duration will be up to a maximum of 15 months.

Conditions

• Chronic Obstructive Lung Disease

Interventions

Type	Name	Description
BIOLOGICAL	Stem 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.

Timeline

• Start date: 2025-06-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-22
• Last updated: 2026-02-12

Locations

2 sites across 1 country: Australia