Crohn's & IBD and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 18 records for HSCT in Crohn's & IBD: 5 recruiting now, 1 labelled Phase 3 or 4, across 10 countries. Snapshot 2026-08-29.
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 HSCT means in this table
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.
The numbers
Every figure below comes from one reproducible query (crohn disease x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 18 |
| Interventional studies in the sample | 17 |
| Recruiting right now | 5 |
| Completed | 0 |
| Terminated, withdrawn or suspended | 10 |
| Phase 3 or Phase 4 records | 1 |
| Countries with at least one site | 10 |
| Median planned enrolment | 20 participants |
| Largest single planned enrolment | 100 participants |
| First / most recent start year | 2001 — 2025 |
How mature is this evidence?
Only 1 of 18 registrations reached a confirmatory phase label, so most of what a clinic can cite is exploratory work by design.
10 of these records (56%) were terminated, withdrawn or suspended, against 0 marked completed; unfinished studies rarely appear in marketing summaries.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 11 | 50% |
| Phase 1 | 6 | 27% |
| Not applicable | 3 | 14% |
| Early Phase 1 | 1 | 5% |
| Phase 3 | 1 | 5% |
Median planned enrolment is 20 participants (largest single study: 100). 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 59% of the country mentions among 10 countries with sites.
| Country | Studies with a site there |
|---|---|
| United States | 13 |
| Iran | 1 |
| Belgium | 1 |
| Canada | 1 |
| France | 1 |
| Italy | 1 |
| Spain | 1 |
| Switzerland | 1 |
| United Kingdom | 1 |
| Brazil | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is evenly split (5 academic or hospital, 5 commercial among the most frequent lead sponsors).
- Paul Szabolcs — 3 records
- Northwestern University — 3 records
- Royan Institute — 1 record
- University of California, Los Angeles — 1 record
- Aaron Etra — 1 record
- European Society for Blood and Marrow Transplantation — 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 |
|---|---|---|---|---|---|
| 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 |
| NCT00297193 — ASTIC Autologous Stem Cell Transplantation for Crohn's Disease | Phase 3 | Terminated | 45 | European Society for Blood and Marrow Transplantation | 2006-06 |
| 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 | Phase 1, Phase 2 | Not Yet Recruiting | 14 | Stanford University | 2025-07 |
| NCT04154735 — Autologous Transplant Targeted Against Crohn's | Phase 2 | Withdrawn | n/a | Northwestern University | 2019-11 |
| NCT02676622 — Autologous Stem Cell Transplant for Refractory Crohn's Disease | Phase 2 | Withdrawn | n/a | Nationwide Children's Hospital | 2013-04 |
| NCT01570348 — Crohn's Allogeneic Transplant Study | Phase 2 | Terminated | 2 | Fred Hutchinson Cancer Center | 2012-07-17 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
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 HSCT studies for Crohn's & IBD are recruiting right now?
5 of 18 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is HSCT 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. 18 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Crohn's & IBD?
1 of 18 records carry a Phase 3 or Phase 4 label and 0 are marked completed. Registrations run from 2001 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.
More on this condition
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.