Human umbilical cord mesenchymal stem cells for psoriasis: a phase 1/2a, single-arm study

Area of Science:

• Immunology
• Dermatology
• Regenerative Medicine

Background:

• Psoriasis is a chronic, immune-mediated disease with limited treatment options.
• Mesenchymal stem cells (MSCs) possess immunomodulatory capabilities.
• Human umbilical cord-derived MSCs (UMSCs) are being investigated for therapeutic potential.

Purpose of the Study:

• To evaluate the safety and efficacy of UMSC infusions in psoriasis patients.
• To explore the underlying mechanisms of UMSC treatment in psoriasis.
• To assess UMSC transplantation (UMSCT) in a phase 1/2a clinical trial.

Main Methods:

• A single-arm clinical trial involving 17 psoriasis patients receiving UMSC infusions.
• Monitoring of adverse events, laboratory parameters, Psoriasis Area and Severity Index (PASI), and Physician's Global Assessment (PGA).
• Analysis of immune cell populations (Tregs, CD4+ memory T cells, Th17 cells) and serum IL-17 levels pre- and post-treatment.

Main Results:

• No significant adverse events were observed during treatment and 6-month follow-up.
• 47.1% of patients achieved ≥40% PASI improvement; 17.6% showed minimal/no disease (PGA).
• UMSCT increased Tregs and CD4+ memory T cells while decreasing Th17 cells and IL-17 levels, particularly in responders.

Conclusions:

• Allogeneic UMSC transplantation is safe and offers partial efficacy for psoriasis.
• Increased Tregs and CD4+ memory T cells, with decreased Th17 cells, correlate with treatment response.
• Baseline Treg levels may predict clinical efficacy of UMSC transplantation in psoriasis.