Abstract
Atopic dermatitis is a chronic and relapsing inflammatory skin disease that is treated with immunosuppressants. However, long-term use of immunosuppressants may cause toxicity and severe side-effects. To confirm the long-term efficacy and safety of clonal mesenchymal stem cell therapy, we performed investigator-initiated clinical trials and long-term observation in five adult patients with moderate to severe atopic dermatitis that was refractory to conventional treatments. The clinical response assessment values such as Eczema Area and Severity Index (EASI) improved significantly at 16weeks, and 80% (4/5) of the patients achieved EASI-50 after one or two treatment cycles. Patients were observed for long-term efficacy and safety for an average of 38weeks (range, 16-86) and showed no serious side-effects. Among the cytokines tested, CCL-17, interleukin (IL)-13, and IL-22 significantly decreased at the end-point of the five participants, two patients who maintained good clinical response over 84weeks showed increased IL-17 cytokine levels in the blood.
Highlights
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease accompanied by severe itching and shows heterogeneous phenotypes
All patients completed one cycle of the clinical trial, and except S001, four patients were subjected to a second cycle due to exacerbation of AD. 127 Improvement of AD using clonal Mesenchymal stem cells (MSCs) All primary efficacy endpoints including a mean reduction of eczema area and severity index (EASI), SCORAD, BSA, and IGA in both cycles were statistically significant (Figure 1A and Supplementary Table 3)
Most 142 primary and secondary endpoints were evaluated at 12 weeks after clonal MSC therapy, and only 143 those of the additional cycle for S003 were evaluated at 17 weeks. 144 145 Long-term efficacy and safety of MSC therapy 146 Participants were followed up for an average of 38 weeks after screening to check how long the improved symptoms were maintained without additional use of systemic steroids and systemic immunomodulators (Figure 1B)
Summary
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease accompanied by severe itching and shows heterogeneous phenotypes. Biologics that target a specific cytokine show long-term safety and efficacy in patients with moderate to severe AD[8]; the proportion of patients who have not achieved complete or nearly complete disease elimination is still high.[2, 9]. Those drugs should be treated through multiple administrations to achieve sufficient efficacy. We performed an investigator-initiated clinical trial to demonstrate the efficacy and safety of multiple doses of allogeneic bone marrow-derived clonal MSCs in five adult patients with moderate to severe AD that was refractory to the conventional treatments. We conducted long-term observation of the patients to confirm the long-term efficacy and safety of clonal MSC therapy and analyzed cytokine biomarkers in the blood of the participants. 69
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