Efficacy and safety of autologous adipose-derived stem cells in subjects with moderate to severe atopic dermatitis: a multicenter, randomized, single-blind, placebo-controlled, phase 2 trial.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Atopic dermatitis (AD) is a chronic skin condition affecting patients' well-being, but conventional treatments have limitations. Mesenchymal stem cells (MSCs) present a promising option for AD therapy, though large-scale clinical studies are scarce. This study aimed to assess the efficacy and safety of autologous adipose tissue-derived MSC (AtMSC) in moderate to severe AD refractory to conventional treatments. This multicenter, randomized, single-blind, placebo-controlled, phase 2 trial included 114 participants. Participants received two intravenous injections of AtMSCs or placebo at 4-week intervals. Clinical assessments, comprising Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), and Investigator's Global Assessment (IGA), were performed every 4 weeks for 16 weeks total. Biomarker analyses were conducted using ELISA. Statistically significant differences between the treatment and placebo groups in EASI total score were observed at 8, 12, and 16 weeks (P = .0.017, 0.015, < 0.001). At week 16, 23.7% [14/59] of participants in the treatment group achieved a 75% or greater reduction in EASI total score (EASI-75), compared to 7.3% [4/55] in the placebo group, with a statistically significant difference (P = .016). In addition, SCORAD, disease severity, and IGA score were also improved in the treatment group compared to the placebo group. Furthermore, the

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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