Medical Review: Dr. Gerald Mastaw, MD – Board-Certified Physician
Last Updated: October 2025
What Is Lupus?
Lupus is a chronic autoimmune disease that can affect nearly any organ in the body.
When the immune system, which normally protects against infection, starts attacking healthy tissues, widespread inflammation and tissue damage can occur.
The most common form is Systemic Lupus Erythematosus (SLE).
Because lupus can look different from person to person, symptoms may range from mild fatigue to severe organ involvement.
Common Symptoms Include:
- Joint or muscle pain
- Fatigue or “flu-like” malaise
- Butterfly-shaped rash across the cheeks or nose
- Sensitivity to sunlight
- Fever, hair loss, or mouth ulcers
- In more advanced cases, kidney, heart, lung, or nervous-system inflammation
People often experience flares, periods when symptoms worsen, followed by times of remission when symptoms ease.
Traditional Treatment Options
Current lupus care focuses on reducing inflammation, controlling symptoms, and preventing organ damage.
Common approaches include:
- Anti-inflammatory medications (NSAIDs) for pain and swelling
- Corticosteroids to control flares
- Immunosuppressants (e.g., azathioprine, mycophenolate, cyclophosphamide)
- Biologic therapies targeting specific immune pathways (such as belimumab or anifrolumab)
- Lifestyle management: stress reduction, sun protection, and gentle exercise
While these therapies can help many patients, some continue to experience flares or medication side effects, and complete disease control may remain challenging.
How Regenerative Medicine Could Help
Regenerative medicine introduces a new perspective for patients living with autoimmune conditions like lupus.
Rather than simply suppressing the immune system, umbilical-cord-derived mesenchymal stem cells (UCT-MSCs) aim to rebalance it.
Potential Benefits of UCT-MSCs in Lupus:
- Calm overactive immune responses by reducing inflammatory cytokines
- Encourage regulatory immune cells, helping restore balance instead of total suppression
- Release trophic and anti-inflammatory factors that aid in tissue repair
- Potentially reduce disease flares and support long-term stability
In research settings, UCT-MSCs have been shown to be well-tolerated, and some studies suggest they can improve disease activity and quality of life in patients with moderate to severe lupus.
Important:
MSC-based regenerative therapies for lupus are investigational and not FDA-approved.
They are being studied as adjunctive options for patients who have not responded fully to conventional care.
Recent Clinical Studies of Regenerative Stem Cell Therapy for Lupus
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.
Could This Be the Right Option for You?
You may wish to explore regenerative options if you:
- Have systemic or cutaneous lupus that remains active despite standard therapy
- Experience recurrent flares or medication intolerance
- Want to learn about immune-modulating, research-based alternatives that may complement current care
At Stemedix, we focus on patient-centered regenerative medicine backed by emerging clinical evidence. Our team reviews your medical history, current treatment, and goals to determine whether regenerative medicine approaches could be a safe adjunctive path forward.
Medical Disclaimer
This page is for educational purposes only and does not constitute medical advice.
Stem cell and secretome-based treatments for lupus are not FDA-approved, and outcomes vary by individual.
Always consult a licensed rheumatologist or qualified healthcare provider before making treatment decisions.
References
- Al-Shaer A. et al. Umbilical Cord MSC-Derived Secretome in SLE. Stem Cell Res Ther., 2025. Full Text
- Chen Y. et al. MSC Therapy in Autoimmune and Rheumatic Diseases: Meta-Analysis. Stem Cell Res Ther., 2025. Full Text
- Dubois M. et al. Allogeneic UC-MSC Treatment for SLE: Phase 1 Trial. PubMed, 2024. Full Text
- He L. et al. Safety and Immune Response of UC-MSCs in Refractory SLE. Front Immunol., 2022. Full Text
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