What research stage is stem-cell therapy for Ulcerative Colitis at?
Of 15 registrations, 0 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 10 | 48% |
| Phase 2 | 6 | 29% |
| Not applicable | 4 | 19% |
| Early Phase 1 | 1 | 5% |
What the phase mix means for Ulcerative Colitis
Registrations sit mainly at early and mid phase. The mature comparator literature is biologic and small-molecule therapy, which reports endoscopic remission rates — the benchmark any new approach has to face.
The later-phase studies themselves
No registered study for this condition carries a Phase 3 or Phase 4 label in this snapshot. That is the single most useful fact on this page: the confirmatory stage has not been reached.
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 20 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 |
|---|---|---|---|---|---|
| NCT05294107 — Intestinal Organoids | n/a | Recruiting | 90 | Rennes University Hospital | 2022-09-06 |
| NCT07740499 — TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease | n/a | Not Yet Recruiting | 80 | IRCCS San Raffaele | 2026-10 |
| NCT03609905 — Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis | Phase 1, Phase 2 | Unknown | 50 | Liaocheng People's Hospital | 2018-07-01 |
| NCT01221428 — Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis | Phase 1, Phase 2 | Unknown | 50 | Qingdao University | 2010-09 |
| NCT06853522 — hucMSCs Exosomes for the Treatment of Active Ulcerative Colitis | Early Phase 1 | Not Yet Recruiting | 40 | Shanghai East Hospital | 2025-05-30 |
Frequently asked
What research stage is stem-cell therapy for Ulcerative Colitis at?
0 of 15 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.