How strong is the evidence for stem-cell therapy in Crohn's & IBD?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 89 records, 23 completed, 13 at Phase 3 or 4, and 29 stopped early (33%). MSC-specific work accounts for 52 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Crohn's & IBD
For fistulas, the endpoint is combined clinical and MRI-confirmed remission at a year. For luminal disease it is endoscopic remission, not symptom diaries — Crohn's symptoms remit spontaneously often enough that uncontrolled improvement reports carry almost no information.
What we can say from registrations alone
- Volume: 89 registered studies since 2001.
- Maturity: 13 confirmatory-phase records.
- Delivery: 23 completed; 29 terminated, withdrawn or suspended.
- Scale: median planned enrolment 24 participants, largest 568.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| 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 |
| 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 |
| NCT04326907 — Treatment of Complex Anal Fistulas Using Centrifuged Adipose Tissue Containing Progenitor Cells | n/a | Completed | 120 | University Hospital of Ferrara | 2016-05-01 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Crohn's & IBD research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Crohn's & IBD?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 89 registered records, 13 at Phase 3/4 and 29 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Approval is product-and-indication specific and changes over time; check the FDA, EMA or your national regulator directly rather than relying on a clinic's summary.
Why do clinics cite hundreds of studies?
Because the registry is public and impressive-looking. What it cannot show — published, controlled outcomes for the exact product — is the part that decides the question.
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.