What research stage is stem-cell therapy for Crohn's & IBD at?
Confirmatory-phase work accounts for 13 of the 89 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 37 | 34% |
| Phase 2 | 36 | 33% |
| Not applicable | 22 | 20% |
| Phase 3 | 11 | 10% |
| Early Phase 1 | 2 | 2% |
| Phase 4 | 2 | 2% |
What the phase mix means for Crohn's & IBD
This is one of the few areas where Phase 3 work reflects a genuine regulatory pathway rather than sponsor optimism. Read the phase distribution with the indication split in mind: the mature end is fistula-specific.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03279081 — Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistul | Phase 3 | Completed | 568 | Tigenix S.A.U. | 2017-09-15 |
| NCT00482092 — Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease | Phase 3 | Completed | 330 | Mesoblast, Inc. | 2007-09-17 |
| NCT01541579 — Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease | Phase 3 | Completed | 278 | Tigenix S.A.U. | 2012-07 |
| NCT06925594 — Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease | Phase 3 | Recruiting | 228 | Jiangsu Topcel-KH Pharmaceutical Co., Ltd. | 2025-03-20 |
| NCT00475410 — Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease | Phase 3 | Completed | 214 | Tigenix S.A.U. | 2007-02 |
| NCT04075825 — Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | Phase 3 | Completed | 150 | Takeda | 2019-11-05 |
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 24 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 |
|---|---|---|---|---|---|
| NCT03279081 — Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistul | Phase 3 | Completed | 568 | Tigenix S.A.U. | 2017-09-15 |
| NCT00482092 — Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease | Phase 3 | Completed | 330 | Mesoblast, Inc. | 2007-09-17 |
| NCT01541579 — Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease | Phase 3 | Completed | 278 | Tigenix S.A.U. | 2012-07 |
| NCT06925594 — Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease | Phase 3 | Recruiting | 228 | Jiangsu Topcel-KH Pharmaceutical Co., Ltd. | 2025-03-20 |
| NCT00475410 — Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease | Phase 3 | Completed | 214 | Tigenix S.A.U. | 2007-02 |
Frequently asked
What research stage is stem-cell therapy for Crohn's & IBD at?
13 of 89 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.