Ulcerative Colitis: cell-therapy evidence by therapy class
Across every stem-cell intervention, ClinicalTrials.gov holds 15 registered records for Ulcerative Colitis — 1 recruiting, 0 at Phase 3 or 4, in 7 countries. Snapshot 2026-08-29.
The condition, and why cells are proposed
Ulcerative colitis is continuous mucosal inflammation of the colon with a relapsing course. Cell studies target immune modulation in disease refractory to biologics. Unlike Crohn's, there is no local-injection niche with regulatory precedent, so the evidence position is weaker despite superficially similar registry counts.
Therapy classes side by side
| Therapy class | Registered | Recruiting | Phase 3/4 | Countries |
|---|---|---|---|---|
| MSC | 11 | 0 | 0 | 5 |
| HSCT | 1 | 0 | 0 | 1 |
| exosomes | 2 | 0 | 0 | 1 |
| PRP | 1 | 0 | 0 | 1 |
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 33% of country mentions among sampled studies; 7 countries host at least one site.
| Country | Studies with a site there |
|---|---|
| United States | 5 |
| China | 4 |
| France | 2 |
| Italy | 1 |
| United Kingdom | 1 |
| Jordan | 1 |
| Spain | 1 |
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 |
|---|---|---|---|---|---|
| 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 |
| NCT02442037 — Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis | Phase 1, Phase 2 | Unknown | 30 | Affiliated Hospital to Academy of Military Medical Sciences | 2015-05 |
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 |
| NCT06853522 — hucMSCs Exosomes for the Treatment of Active Ulcerative Colitis | n/a | Not Yet Recruiting | n/a | Shanghai East Hospital | 2025-05-30 |
| NCT05176366 — Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis | n/a | Terminated | n/a | Direct Biologics, LLC | 2022-12-19 |
| NCT05294107 — Intestinal Organoids | n/a | Recruiting | n/a | Rennes University Hospital | 2022-09-06 |
| NCT05578508 — Stem Cells for the Treatment of Pouchitis | n/a | Withdrawn | n/a | The Cleveland Clinic | 2022-04 |
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 Ulcerative Colitis 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 Ulcerative Colitis?
15 registered records mention a stem-cell intervention for this condition (2026-08-29 snapshot), of which 1 were recruiting.
Which therapy class is furthest along for Ulcerative Colitis?
Ranked by Phase 3/4 records: MSC (0), HSCT (0), 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.