MSC vs HSCT for Crohn's & IBD: what the registries show
For Crohn's & IBD, the registry holds 52 MSC records against 18 HSCT records. MSC carries the larger research programme; neither column is a head-to-head efficacy result. Snapshot 2026-08-29.
Side by side
| Metric | MSC | HSCT |
|---|---|---|
| Registered studies | 52 | 18 |
| Recruiting now | 6 | 5 |
| Phase 3 or 4 records | 4 | 1 |
| Completed | 13 | 0 |
| Stopped early | 18 | 10 |
| Countries with sites | 17 | 10 |
| Median planned enrolment | 20 | 20 |
| First registration year | 2,006 | 2,001 |
The condition underneath the comparison
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.
MSC: what it is
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.
HSCT: what it is
Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.
Maturity difference
MSC has 4 Phase 3/4 records and 13 completed studies; HSCT has 1 and 0. Where both sit early on the ladder, the honest answer to "which works better" is that registrations cannot tell you.
Leading MSC studies
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07077746 — HB-adMSCs for the Treatment of Crohn's Disease | Phase 2 | Recruiting | 46 | Hope Biosciences Research Foundation | 2026-07-14 |
| NCT06918808 — DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease | Phase 2 | Recruiting | 36 | Direct Biologics, LLC | 2025-05-19 |
| NCT03901235 — MSC Intratissular Injection in Crohn Disease Patients | Phase 1, Phase 2 | Recruiting | 60 | University of Liege | 2018-01-15 |
| NCT05039411 — Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease | Phase 1 | Recruiting | 5 | CryoCord Sdn Bhd | 2022-03-01 |
| NCT05974280 — Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells | n/a | Recruiting | 20 | Nantes University Hospital | 2024-01-02 |
Leading HSCT studies
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04224558 — Stem Cell Transplantation in Crohn's Disease | Phase 1, Phase 2 | Recruiting | 15 | Cedars-Sinai Medical Center | 2019-11-15 |
| NCT03219359 — Autologous Stem Cell Transplant for Crohn's Disease | Phase 2 | Recruiting | 50 | Aaron Etra | 2018-02-22 |
| NCT01962415 — Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT | Phase 2 | Recruiting | 100 | Paul Szabolcs | 2014-02-04 |
| NCT00692939 — Autologous Stem Cell Transplantation for Crohn's Disease | Phase 1, Phase 2 | Recruiting | 20 | Paul Szabolcs | 2012-06-26 |
| NCT04528355 — Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC | n/a | Recruiting | 50 | Paul Szabolcs | 2020-08-20 |
The honest comparison
Head-to-head trials putting these two approaches in the same protocol are rare or absent for most conditions. Comparing counts from separate registry queries shows where research effort went — driven by cost, regulation and sponsor interest as much as by biology. Anyone presenting one column of this table as proof of superiority is overreading it.
Frequently asked
Is MSC better than HSCT for Crohn's & IBD?
The registries cannot answer that. They show research volume and maturity, not comparative effectiveness: 52 vs 18 registered records (2026-08-29).
Which has more late-stage research for Crohn's & IBD?
MSC: 4 Phase 3/4 records. HSCT: 1.
Can a clinic offer both?
Some do, which is itself worth questioning — a provider offering every modality for every condition is describing a business model, not a treatment rationale.
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.