Lupus (SLE) and Mesenchymal stem/stromal cells (MSC): what the trial registry contains
The ClinicalTrials.gov registry holds 21 records for MSC in Lupus (SLE): 3 recruiting now, 1 labelled Phase 3 or 4, across 7 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 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 (systemic lupus erythematosus x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 21 |
| Interventional studies in the sample | 20 |
| Recruiting right now | 3 |
| Completed | 6 |
| Terminated, withdrawn or suspended | 0 |
| Phase 3 or Phase 4 records | 1 |
| Countries with at least one site | 7 |
| Median planned enrolment | 20 participants |
| Largest single planned enrolment | 230 participants |
| First / most recent start year | 2007 — 2025 |
How mature is this evidence?
A small later-stage tail exists (1 of 21 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.
Of those, 6 are marked completed and 0 were terminated, withdrawn or suspended — a stop rate of 0%, worth weighing when a clinic quotes 'ongoing research' as reassurance.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 13 | 46% |
| Phase 1 | 10 | 36% |
| Early Phase 1 | 2 | 7% |
| Not applicable | 2 | 7% |
| Phase 3 | 1 | 4% |
Median planned enrolment is 20 participants (largest single study: 230). 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 7 countries; China alone accounts for about 50% of mentions, so 'internationally researched' can still mean concentrated in a few regulatory environments.
| Country | Studies with a site there |
|---|---|
| China | 9 |
| South Korea | 3 |
| United States | 2 |
| Belarus | 1 |
| Spain | 1 |
| France | 1 |
| Pakistan | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
Among the top lead sponsors, 7 are universities or hospitals and 2 are companies, making this a academic area.
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — 2 records
- Medical University of South Carolina — 2 records
- Corestemchemon, Inc. — 2 records
- Chinese PLA General Hospital — 1 record
- Organ Transplant Institute, China — 1 record
- The First Affiliated Hospital of Dalian Medical University — 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 |
|---|---|---|---|---|---|
| NCT07041801 — Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells | Phase 1, Phase 2 | Recruiting | 58 | Shenzhen Beike Bio-Technology Co., Ltd. | 2025-06-28 |
| NCT06058078 — RY_SW01 Cell Injection Therapy in Active Lupus Nephritis | Phase 2 | Recruiting | 60 | Jiangsu Renocell Biotech Company | 2023-08-17 |
| NCT03673748 — Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells | Phase 2 | Recruiting | 20 | Red de Terapia Celular | 2022-12-27 |
| NCT05631717 — The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in the Treatment of LN | Phase 3 | Unknown | 40 | The Affiliated Nanjing Drum Tower Hospital of Nanjing Univer | 2022-10-01 |
| NCT06888973 — Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases | Phase 1, Phase 2 | Enrolling By Invitation | 200 | National Institute of Blood and Marrow Transplant (NIBMT), P | 2025-02-01 |
| NCT04184258 — Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells | Phase 1, Phase 2 | Completed | 7 | Institute of Biophysics and Cell Engineering of National Aca | 2019-07-01 |
| NCT04835883 — Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients | Phase 2 | Unknown | 10 | Hanyang University Seoul Hospital | 2019-09-26 |
| NCT03562065 — Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord | Phase 1, Phase 2 | Unknown | 10 | Assistance Publique - Hôpitaux de Paris | 2019-09-11 |
| NCT02633163 — Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE) | Phase 2 | Completed | 81 | Medical University of South Carolina | 2018-11-18 |
| NCT03580291 — Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN) | Phase 2 | Unknown | 230 | Lingyun Sun | 2018-08-01 |
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 MSC studies for Lupus (SLE) are recruiting right now?
3 of 21 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 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. 21 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on MSC for Lupus (SLE)?
1 of 21 records carry a Phase 3 or Phase 4 label and 6 are marked completed. Registrations run from 2007 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.