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NCT06986070: SORT-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

Recruiting now Phase 1 Last updated 9 February 2026
What this trial tests

Phase 1 trial testing Stem cells in Chronic Obstructive Lung Disease in 18 participants. Currently enrolling.

Timeline
13 June 2025
Primary endpoint
1 December 2026
1 December 2026

Quick facts

Lead sponsorSMSbiotech
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment18
Start date13 June 2025
Primary completion1 December 2026
Estimated completion1 December 2026
Sites2 locations across Australia

Drugs / interventions tested

Conditions studied

Sponsor

SMSbiotech

Who can join

Adults 39 to 69, any sex, with Chronic Obstructive Lung Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Stem cells in organogenesis and regeneration.
    Mim TJ, Ahmad I, Basher SR, Rahman MF, et al · · 2026 · cited 2× · PMID 41549301 · DOI 10.1186/s13287-025-04889-z

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Other trials of Stem cells

Trials testing the same drug.

Other recruiting trials for Chronic Obstructive Lung Disease

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06986070.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing