Crohn's & IBD and Mesenchymal stem/stromal cells (MSC): what the trial registry contains

Why this is studied in Crohn's & IBD

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.

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 (crohn disease x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.

How mature is this evidence?

Only 4 of 52 registrations reached a confirmatory phase label, so most of what a clinic can cite is exploratory work by design.

13 records are marked completed and 18 ended early (terminated, withdrawn or suspended): 35% of registrations did not run to plan.

Median planned enrolment is 20 participants (largest single study: 330). 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

Research is not evenly spread: United States carries about 39% of the country mentions among 17 countries with sites.

Legal pathway differs by country — see where cell therapy is legal, by country.

Who runs them

The sponsor mix is commercial (2 academic or hospital, 18 commercial among the most frequent lead sponsors).

• Anthony Lembo — 5 records
• Mesoblast, Inc. — 4 records
• Direct Biologics, LLC — 3 records
• The Cleveland Clinic — 3 records
• Anterogen Co., Ltd. — 3 records
• University of Liege — 2 records

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.

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 Crohn's & IBD are recruiting right now?

6 of 52 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 Crohn's & IBD?

Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 52 registered studies tell you research exists, not that a product cleared review.

How advanced is the research on MSC for Crohn's & IBD?

4 of 52 records carry a Phase 3 or Phase 4 label and 13 are marked completed. Registrations run from 2006 to 2026.

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.