Lupus (SLE): cell-therapy evidence by therapy class
Across every stem-cell intervention, ClinicalTrials.gov holds 44 registered records for Lupus (SLE) — 5 recruiting, 4 at Phase 3 or 4, in 10 countries. Snapshot 2026-08-29.
The condition, and why cells are proposed
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.
Therapy classes side by side
Counts come from separate registry queries per class; a study testing two interventions can appear in more than one row, so rows do not sum to the all-interventions total.
Geography of the research
United States accounts for about 42% of country mentions among sampled studies; 10 countries host at least one site.
| Country | Studies with a site there |
|---|---|
| United States | 17 |
| China | 11 |
| South Korea | 3 |
| France | 2 |
| Brazil | 2 |
| Belarus | 1 |
| Spain | 1 |
| Germany | 1 |
The largest registered studies
Sorted by planned enrolment — size is not quality, but a 300-participant trial can answer questions a 12-participant series cannot.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04870333 — PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V | Phase 2, Phase 3 | Completed | 2,240 | Cambridge University Hospitals NHS Foundation Trust | 2021-02-19 |
| NCT03580291 — Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN) | Phase 2 | Unknown | 230 | Lingyun Sun | 2018-08-01 |
| 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 |
| NCT06485648 — Mesenchymal Stem Cell Transfusion for the Treatment of Refractory Lupus Nephritis | Early Phase 1 | Not Yet Recruiting | 96 | Chinese PLA General Hospital | 2024-10-01 |
| 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 |
| NCT06058078 — RY_SW01 Cell Injection Therapy in Active Lupus Nephritis | Phase 2 | Recruiting | 60 | Jiangsu Renocell Biotech Company | 2023-08-17 |
Most recently registered
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT05029336 — Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | n/a | Recruiting | n/a | Stephan Grupp MD PhD | 2026-03 |
| NCT07301164 — Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases | n/a | Not Yet Recruiting | n/a | Peking University Third Hospital | 2025-12-11 |
| NCT07041801 — Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells | n/a | Recruiting | n/a | Shenzhen Beike Bio-Technology Co., Ltd. | 2025-06-28 |
| NCT06255028 — A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases | n/a | Active Not Recruiting | n/a | Century Therapeutics, Inc. | 2025-02-06 |
| NCT06888973 — Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases | n/a | Enrolling By Invitation | n/a | National Institute of Blood and Marrow Transplant (NIBMT), P | 2025-02-01 |
Reading this honestly
A registry is a plan repository. Counting entries tells you what people intended to study, which is a weaker thing than what they found. For Lupus (SLE) specifically, the practical question is which registered study — if any — matches the product a provider is offering, and what its outcome measures actually are.
Frequently asked
How many stem-cell trials exist for Lupus (SLE)?
44 registered records mention a stem-cell intervention for this condition (2026-08-29 snapshot), of which 5 were recruiting.
Which therapy class is furthest along for Lupus (SLE)?
Ranked by Phase 3/4 records: MSC (1), HSCT (1), exosomes (0), PRP (0).
Does a recruiting trial mean I can be treated?
No. Trials have eligibility criteria, and joining one is not the same as buying a treatment. Paying a clinic for an unproven intervention outside a registered study gives you neither the protections nor the data collection of a trial.
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.
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.