2025 – Double-Blind RCT Using MSC Secretome
Title: Umbilical Cord MSC-Derived Secretome as a Potential Treatment for SLE: A Double-Blind Randomized Controlled Trial
Journal: Stem Cell Research & Therapy – Full Text
Summary:
Twenty-nine women with active lupus received weekly injections of MSC-secretome (the bioactive solution produced by MSCs) or placebo for six weeks.
Patients receiving MSC-secretome had significant reductions in lupus disease activity scores and improved immune markers such as complement C3 and lower inflammatory cytokines (IL-6, TNF-α).
The treatment was safe and well-tolerated, with no severe adverse events.
2025 – Meta-Analysis Across Autoimmune Diseases (Including Lupus)
Title: Efficacy and Safety of MSC Transplantation in Autoimmune and Rheumatic Diseases
Journal: Stem Cell Research & Therapy – Full Text
Summary:
This large review analyzed 42 randomized trials (2,183 patients).
In lupus subgroups, MSC therapy significantly lowered SLE Disease Activity Index (SLEDAI) scores (SMD ≈ –2.32, p=0.0003).
No increase in adverse events was found versus controls.
Researchers concluded MSC therapy is safe and shows measurable improvement in lupus disease activity.
2024 – Phase 1 Dose-Escalation Trial in France
Title: Allogeneic UC-MSC Therapy for Refractory Lupus: A Phase 1 Study
Journal: PubMed Central – Full Text
Summary:
Eight patients with severe, treatment-resistant lupus received escalating doses of UC-MSCs (2–4 million cells/kg).
Treatment was well-tolerated, with only mild transient infusion reactions in two participants.
Over a year of follow-up, disease activity stabilized or improved, supporting safety even at higher doses.
2022 – Phase 1 UC-MSC Trial for Refractory SLE
Title: Safety, Immunologic Effects, and Clinical Response of UC-MSCs in SLE
Journal: Frontiers in Immunology – Full Text
Summary:
Six patients with active lupus unresponsive to medication received a single UC-MSC infusion (1×10⁶ cells/kg).
By 24 weeks, 83% achieved the lupus responder endpoint (SRI-4), showing reduced disease activity and normalization of B-cell profiles.
No serious side effects occurred.
The trial concluded UC-MSC infusion was safe and associated with meaningful clinical improvement.
Regenerative Medicine is still considered an experimental procedure and not approved by the FDA. Patients must consider realistic expectations in their research and possible therapy options.