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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
Phase 1 trial testing Stem cells in Chronic Obstructive Lung Disease in 18 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | SMSbiotech |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 13 June 2025 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 2 locations across Australia |
Drugs / interventions tested
- Stem cells — full drug profile →
Conditions studied
- Chronic Obstructive Lung Disease — all drugs for Chronic Obstructive Lung Disease →
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.
-
Adverse events.
Time frame: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.
Treatment emergent adverse events and serious adverse events. -
Dose limiting toxicity.
Time frame: Day 1, 2, 3, 4, 5, 8, 9, 21, 28, Month 3 and Month 6.
Any treatment emergent adverse event that ii treatment related and classified as severe or the event is classified as a serious adverse event. -
Safety laboratory testing
Time frame: Screening, Day 2, 3, 5, 9, 21 and 28.
All laboratory parameters will be summarized using descriptive statistics for each cohort and overall, for all time points assessed, including change from baseline for all post-dose assessments. Selected laboratory test results will be graded in accordance with the NCI CTCAE criteria.
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):
-
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
Verify or expand the search:
- PubMed search for NCT06986070
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Chronic Obstructive Lung Disease
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06986070 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SMSbiotech
- Last refreshed: 9 February 2026
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