Long‐term efficacy and safety of intravenous injection of clonal mesenchymal stem cells derived from bone marrow in five adults with moderate to severe atopic dermatitis

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 16 weeks, 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 38 weeks (range: 16-86 weeks) and showed no serious side effects. Among the cytokines tested, CCL-17, IL-13 and IL-22 significantly decreased at the endpoint of the five participants, two patients who maintained good clinical response over 84 weeks showed increased IL-17 cytokine levels in the blood.

Therapeutic potential of mesenchymal stem cells for refractory inflammatory and immune skin diseases

“… 96 Other 5 patients without ideal respondence to conventional treatments were administrated with 1.0 × 10 6 cells/kg MSCs intravenously and showed good clinical improvement in the follow-up. 97 Various studies with a larger number of patients, more reasonable grouping and MSC dose selection criteria are working together for clinical efficacy demonstration ( Table 4 ).…”

Therapeutic effects of mesenchymal stem cells and their derivatives in common skin inflammatory diseases: Atopic dermatitis and psoriasis

“…They found that the Eczema Area and Severity Index (EASI) improved significantly at 16 weeks, which had a long-term efficacy for an average of 38 weeks (range, 16–86), whereas it showed no serious side effects in the patients. Moreover, the pro-inflammatory cytokines in their blood significantly decreased at the end point ( 28 ). Similarly, Kim et al.…”

“…They found that the Eczema Area and Severity Index (EASI) improved significantly at 16 weeks, which had a longterm efficacy for an average of 38 weeks (range, 16-86), whereas it showed no serious side effects in the patients. Moreover, the proinflammatory cytokines in their blood significantly decreased at the end point (28). Similarly, Kim et al recruited 34 patients with moderate-to-severe AD with a follow-up for 1 and 3 months revealed that subcutaneously administering a high dose of UCB-MSCs (5.0 × 10 7 cells) could effectively reduce the symptom of AD and with little adverse effects and no relapse (29).…”

“…The target to improving those MSCs from the patients of skin inflammatory diseases may become another cured target for clinical treatments ( 25 – 27 ). However, there are still mild adverse effects such as headache, fever, and the risk of embolism, but there have been no documented cases of embolism during treatment of AD and psoriasis patients ( 28 , 29 ). It is worth noting that various administrations of MSCs and their derivatives may have obviously different effects on treating common chronic skin inflammatory diseases, AD, and psoriasis.…”