What research stage is stem-cell therapy for Lupus (SLE) at?
Confirmatory-phase work accounts for 4 of the 44 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 23 | 42% |
| Phase 1 | 20 | 36% |
| Not applicable | 5 | 9% |
| Phase 3 | 4 | 7% |
| Early Phase 1 | 3 | 5% |
What the phase mix means for Lupus (SLE)
Phase distribution mixes a mature transplantation literature with genuinely first-in-human cell-engineering work. Treating those as one evidence base overstates the maturity of the newer, headline-generating approaches.
The later-phase studies themselves
| 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 |
| 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 |
| NCT03979976 — Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus | Phase 2, Phase 3 | Completed | 37 | Federal University of São Paulo | 2011-03 |
| NCT05063513 — Autologous Stem Cell Transplantation: International Lupus Trial | Phase 2, Phase 3 | Withdrawn | n/a | European Society for Blood and Marrow Transplantation | 2009-07 |
How to read phase labels
The ladder runs from tolerability through signal-finding to a controlled, adequately powered test of benefit. Cell-therapy records frequently carry no phase at all, because observational designs and some tissue-based protocols sit outside the drug framework entirely. Read that as a classification gap, not a verdict.
Median planned enrolment across sampled studies here is 20 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| 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 |
Frequently asked
What research stage is stem-cell therapy for Lupus (SLE) at?
4 of 44 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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.