Ulcerative Colitis and Mesenchymal stem/stromal cells (MSC): what the trial registry contains
The ClinicalTrials.gov registry holds 11 records for MSC in Ulcerative Colitis: 0 recruiting now, 0 labelled Phase 3 or 4, across 5 countries. Snapshot 2026-08-29.
Why this is studied in Ulcerative Colitis
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.
What MSC means in this table
Mesenchymal stromal cells are the workhorse of commercial cell therapy: easy to source from fat, cord or marrow, easy to expand, and rarely characterised in the same way twice. Their proposed action is paracrine — signalling molecules that damp inflammation — rather than replacement of lost tissue. That matters when reading counts like these, because two studies filed under the same label can test materially different products at different doses by different routes.
The numbers
Every figure below comes from one reproducible query (ulcerative colitis x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 11 |
| Interventional studies in the sample | 11 |
| Recruiting right now | 0 |
| Completed | 0 |
| Terminated, withdrawn or suspended | 4 |
| Phase 3 or Phase 4 records | 0 |
| Countries with at least one site | 5 |
| Median planned enrolment | 20 participants |
| Largest single planned enrolment | 50 participants |
| First / most recent start year | 2010 — 2025 |
How mature is this evidence?
The registry shows exploratory work only — 11 records, no Phase 3 or 4 label, 0 open to enrolment right now.
Registrations do not all survive contact with recruitment — 0 completed here, 4 stopped early, giving a 36% attrition rate.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 9 | 53% |
| Phase 2 | 6 | 35% |
| Not applicable | 1 | 6% |
| Early Phase 1 | 1 | 6% |
Median planned enrolment is 20 participants (largest single study: 50). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
The work is distributed across 5 countries; United States alone accounts for about 36% of mentions, so 'internationally researched' can still mean concentrated in a few regulatory environments.
| Country | Studies with a site there |
|---|---|
| United States | 4 |
| China | 4 |
| France | 1 |
| Jordan | 1 |
| Spain | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
Lead sponsors split roughly 2 academic or hospital against 5 commercial — a commercial profile. Commercial sponsorship is not a red flag by itself, but it changes publication incentives.
- The Cleveland Clinic — 2 records
- Direct Biologics, LLC — 1 record
- Liaocheng People's Hospital — 1 record
- University Hospital, Montpellier — 1 record
- Hanan Jafar — 1 record
- Mayo Clinic — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04312113 — Angiographic Delivery of AD-MSC for Ulcerative Colitis | Phase 1 | Active Not Recruiting | 20 | Mayo Clinic | 2020-11-16 |
| NCT04543994 — Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC) | Phase 1, Phase 2 | Terminated | 7 | The Cleveland Clinic | 2020-11-10 |
| NCT03609905 — Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis | Phase 1, Phase 2 | Unknown | 50 | Liaocheng People's Hospital | 2018-07-01 |
| NCT03299413 — Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease | Phase 1, Phase 2 | Unknown | 20 | Hanan Jafar | 2017-06-05 |
| 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 |
| NCT01914887 — Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis | Phase 1, Phase 2 | Unknown | 8 | Instituto de Investigación Hospital Universitario La Paz | 2013-06 |
| NCT01221428 — Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis | Phase 1, Phase 2 | Unknown | 50 | Qingdao University | 2010-09 |
| NCT05176366 — Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis | Phase 1 | Terminated | 4 | Direct Biologics, LLC | 2022-12-19 |
| NCT05578508 — Stem Cells for the Treatment of Pouchitis | Phase 1 | Withdrawn | n/a | The Cleveland Clinic | 2022-04 |
| NCT06853522 — hucMSCs Exosomes for the Treatment of Active Ulcerative Colitis | Early Phase 1 | Not Yet Recruiting | 40 | Shanghai East Hospital | 2025-05-30 |
What this page does and does not tell you
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.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many MSC studies for Ulcerative Colitis are recruiting right now?
0 of 11 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is MSC an approved treatment for Ulcerative Colitis?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 11 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on MSC for Ulcerative Colitis?
0 of 11 records carry a Phase 3 or Phase 4 label and 0 are marked completed. Registrations run from 2010 to 2025.
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.