Lupus (SLE) and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 17 records for HSCT in Lupus (SLE): 2 recruiting now, 1 labelled Phase 3 or 4, across 4 countries. Snapshot 2026-08-29.
Why this is studied in Lupus (SLE)
Systemic lupus erythematosus is autoimmunity against nuclear antigens with relapsing multi-organ involvement. Two lines exist: mesenchymal immunomodulation, and immune reset through haematopoietic transplantation or CAR-T, the latter producing the most striking recent case series in autoimmunity. Those are radically different risk-benefit propositions.
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 (systemic lupus erythematosus x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 17 |
| Interventional studies in the sample | 17 |
| Recruiting right now | 2 |
| Completed | 5 |
| Terminated, withdrawn or suspended | 6 |
| Phase 3 or Phase 4 records | 1 |
| Countries with at least one site | 4 |
| Median planned enrolment | 16 participants |
| Largest single planned enrolment | 52 participants |
| First / most recent start year | 2000 — 2026 |
How mature is this evidence?
A small later-stage tail exists (1 of 17 records at Phase 3 or 4); the centre of gravity is still Phase 1 and 2 work sized for safety rather than proof of benefit.
Completion status: 5 completed, 6 stopped early (35% of all records). A registration is a plan, not a result.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 9 | 45% |
| Phase 1 | 7 | 35% |
| Not applicable | 3 | 15% |
| Phase 3 | 1 | 5% |
Median planned enrolment is 16 participants (largest single study: 52). 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 4 countries; United States alone accounts for about 75% of mentions, so 'internationally researched' can still mean concentrated in a few regulatory environments.
| Country | Studies with a site there |
|---|---|
| United States | 12 |
| China | 2 |
| France | 1 |
| Germany | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is academic (7 academic or hospital, 1 commercial among the most frequent lead sponsors).
- Northwestern University — 3 records
- Organ Transplant Institute, China — 1 record
- The First Affiliated Hospital of Dalian Medical University — 1 record
- Fairview University Medical Center — 1 record
- Stanford University — 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 |
|---|---|---|---|---|---|
| NCT05029336 — Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Phase 2 | Recruiting | 20 | Stephan Grupp MD PhD | 2026-03 |
| NCT05508009 — Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor | Phase 1, Phase 2 | Recruiting | 12 | Alice Bertaina | 2023-01-10 |
| NCT05063513 — Autologous Stem Cell Transplantation: International Lupus Trial | Phase 2, Phase 3 | Withdrawn | n/a | European Society for Blood and Marrow Transplantation | 2009-07 |
| NCT00659217 — Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis | Phase 1, Phase 2 | Unknown | 20 | Organ Transplant Institute, China | 2008-05 |
| NCT00750971 — Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST) | Phase 2 | Unknown | 30 | Charite University, Berlin, Germany | 2008-08 |
| NCT00278538 — Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus | Phase 2 | Completed | 32 | Northwestern University | 2005-09-23 |
| NCT00230035 — Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST) | Phase 2 | Withdrawn | n/a | National Institute of Allergy and Infectious Diseases (NIAID | 2005-09 |
| NCT00076752 — Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus | Phase 2 | Completed | 9 | National Cancer Institute (NCI) | 2004-01-30 |
| NCT00271934 — Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study | Phase 2 | Completed | 52 | Northwestern University | 2002-09 |
| NCT00684255 — Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) | Phase 1 | Terminated | 1 | New York Medical College | 2007-08 |
What this page does and does not tell you
Treat this as a map of research activity. It tells you whether a claim has an evidence programme behind it — not whether the treatment helped anyone.
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 Lupus (SLE) are recruiting right now?
2 of 17 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 Lupus (SLE)?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 17 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Lupus (SLE)?
1 of 17 records carry a Phase 3 or Phase 4 label and 5 are marked completed. Registrations run from 2000 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.
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.