What research stage is stem-cell therapy for COPD & Lung Disease at?
Of 34 registrations, 2 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 17 | 39% |
| Phase 2 | 13 | 30% |
| Not applicable | 10 | 23% |
| Phase 3 | 2 | 5% |
| Early Phase 1 | 2 | 5% |
What the phase mix means for COPD & Lung Disease
The registered base is dominated by early and mid-phase safety work. Where later-phase designs appear, they use exacerbation rate rather than symptom scores, because symptoms respond strongly to attention, environment change and pulmonary rehabilitation.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT00826683 — Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC) | Phase 3 | Completed | 140 | University Hospital, Limoges | 2009-03 |
| NCT04018729 — Cell Therapy Associated With Endobronchial Valve | Phase 2, Phase 3 | Recruiting | 34 | Hospital de Clinicas de Porto Alegre | 2019-11-19 |
How to read phase labels
Phase 1 asks whether a dose is tolerated, usually in a small group without a control arm. Phase 2 looks for a signal and refines dosing. Phase 3 is confirmatory: larger, controlled, powered to test whether the intervention changes an outcome that matters. Not applicable appears for observational studies or where the sponsor assigned no phase, which is common in cell therapy and not a quality mark either way.
Median planned enrolment across sampled studies here is 30 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03899298 — Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions | Phase 1 | Not Yet Recruiting | 5,000 | R3 Stem Cell | 2019-09-01 |
| NCT01953523 — Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions | n/a | Completed | 3,000 | Elliot Lander | 2013-09-02 |
| NCT03040674 — An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease | n/a | Completed | 489 | Lung Institute | 2017-01-03 |
| NCT03044431 — Autologous Stem Cell Treatment for Chronic Lung Disease Study | n/a | Completed | 207 | Lung Institute | 2016-04-01 |
| NCT00826683 — Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC) | Phase 3 | Completed | 140 | University Hospital, Limoges | 2009-03 |
Frequently asked
What research stage is stem-cell therapy for COPD & Lung Disease at?
2 of 34 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.