Crohn's & IBD: cell-therapy evidence by therapy class
Across every stem-cell intervention, ClinicalTrials.gov holds 89 registered records for Crohn's & IBD — 14 recruiting, 13 at Phase 3 or 4, in 26 countries. Snapshot 2026-08-29.
The condition, and why cells are proposed
Crohn's disease is transmural intestinal inflammation with a relapsing course. Two very different cell propositions exist: local injection for perianal fistulas, which has the strongest regulatory footing in the whole field, and systemic infusion for luminal disease, which does not. Conflating them is how weak offers borrow credibility from strong evidence.
Therapy classes side by side
Counts come from separate registry queries per class; a study testing two interventions can appear in more than one row, so rows do not sum to the all-interventions total.
Geography of the research
United States accounts for about 36% of country mentions among sampled studies; 26 countries host at least one site.
| Country | Studies with a site there |
|---|---|
| United States | 35 |
| Spain | 13 |
| France | 10 |
| South Korea | 7 |
| Italy | 7 |
| Belgium | 7 |
| China | 6 |
| Israel | 5 |
The largest registered studies
Sorted by planned enrolment — size is not quality, but a 300-participant trial can answer questions a 12-participant series cannot.
| 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 |
Most recently registered
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07740499 — TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease | n/a | Not Yet Recruiting | n/a | IRCCS San Raffaele | 2026-10 |
| NCT07077746 — HB-adMSCs for the Treatment of Crohn's Disease | n/a | Recruiting | n/a | Hope Biosciences Research Foundation | 2026-07-14 |
| NCT07010926 — A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of L2-01 in Subjects With Crohn's Disease | n/a | Not Yet Recruiting | n/a | L2 Bio, LLC | 2025-08-15 |
| NCT06986382 — Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients | n/a | Not Yet Recruiting | n/a | Stanford University | 2025-07 |
| NCT06918808 — DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease | n/a | Recruiting | n/a | Direct Biologics, LLC | 2025-05-19 |
Reading this honestly
None of these numbers say the therapy works. They say how much organised research exists and how far along it is; effect sizes live in published results, not registry entries. For Crohn's & IBD specifically, the practical question is which registered study — if any — matches the product a provider is offering, and what its outcome measures actually are.
Frequently asked
How many stem-cell trials exist for Crohn's & IBD?
89 registered records mention a stem-cell intervention for this condition (2026-08-29 snapshot), of which 14 were recruiting.
Which therapy class is furthest along for Crohn's & IBD?
Ranked by Phase 3/4 records: MSC (4), HSCT (1), exosomes (0), PRP (0).
Does a recruiting trial mean I can be treated?
No. Trials have eligibility criteria, and joining one is not the same as buying a treatment. Paying a clinic for an unproven intervention outside a registered study gives you neither the protections nor the data collection of a trial.
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.
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.