EHLBIO's 'ADSTEM Inj.' Demonstrates Potential for Atopic Dermatitis Treatment

The Phase 2 clinical trial results of ADSTEM Inj., a stem cell treatment for atopic dermatitis, have been published in the international journal Stem Cell Research & Therapy. This multicenter clinical trial evaluated the safety and efficacy of ADSTEM Inj. in 114 patients with atopic dermatitis.

Atopic dermatitis is a chronic inflammatory condition characterized by both immune dysregulation and impaired skin barrier function. Severe itching, recurrent inflammation, dry skin, and damage to the skin barrier can affect sleep and daily life. Treatment options include topical therapies, immunomodulators, biologics, and oral targeted therapies, although clinical presentation and treatment response vary among individuals.

Phase 2 Clinical Trial Involving 114 Patients at Six University Hospitals

Six university hospitals participated in this study: Chung-Ang University Hospital, Korea University Ansan Hospital, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Chungnam National University Hospital, Seoul National University Hospital, and Kyung Hee University Hospital. A total of 114 patients with atopic dermatitis received two intravenous administrations of either ADSTEM Inj. or placebo, four weeks apart.

Researchers assessed outcomes at Week 16, focusing on the Eczema Area and Severity Index (EASI), which measures the severity of atopic dermatitis. The EASI-50 response rate refers to the proportion of patients whose EASI scores decreased by at least 50% from baseline.

The analysis showed that the EASI-50 response rate was significantly higher in the ADSTEM Inj. group than in the placebo group. Because these findings come from a Phase 2 clinical trial, larger studies will be needed to confirm their reproducibility and collect long-term data.

Research Using Autologous Adipose-Derived Mesenchymal Stem Cells

ADSTEM Inj. is an injectable treatment developed using autologous adipose-derived mesenchymal stem cells. Research is ongoing into the properties of mesenchymal stem cells, including their ability to secrete diverse bioactive substances and interact with surrounding cells.

The paracrine effect refers to the influence of substances secreted by cells on nearby tissues and immune responses. EHL BIO developed ADSTEM Inj. with a focus on these immunomodulatory properties, aiming to alleviate systemic immune imbalance associated with atopic dermatitis.

In atopic dermatitis, impaired skin barrier function and altered immune responses may occur together. This clinical trial assessed clinical outcomes following intravenous administration of autologous adipose-derived mesenchymal stem cells in patients with atopic dermatitis.

Secondary Outcome Measures and Safety Assessment

A single measure cannot provide a complete assessment of atopic dermatitis. In this study, secondary assessment tools, including SCORAD (Scoring Atopic Dermatitis) and IGA (Investigator's Global Assessment), were used alongside EASI.

The reported study findings showed an overall trend toward greater symptom improvement on secondary measures in the ADSTEM Inj. group than in the placebo group. Each assessment tool was used to evaluate different aspects of the condition.

In the safety assessment, most reported adverse events were mild, and no serious adverse events were identified. However, because Phase 2 data are limited to a defined study population and period, subsequent clinical studies should evaluate the safety of repeated administration and assess long-term safety.

The Next Step for ADSTEM Inj.: A Phase 3 Clinical Trial

EHLBIO announced that it has received Phase 3 IND approval from the Ministry of Food and Drug Safety for ADSTEM Inj. in patients with atopic dermatitis. The planned Phase 3 clinical trial will seek to confirm efficacy and safety in a larger patient population.

The next stage of development will focus on whether the Phase 2 findings can be reproduced in larger studies and on collecting long-term safety data. ADSTEM Inj. remains a cell therapy under development, and approval of a clinical trial protocol does not constitute marketing authorization or approval for use in routine clinical practice.

The publication in Stem Cell Research & Therapy is noteworthy for presenting clinical data from a study evaluating autologous adipose-derived mesenchymal stem cell-based treatment in patients with atopic dermatitis. Additional large-scale clinical trials and long-term validation will be needed before stem cell therapy can become a standard treatment for atopic dermatitis.

About EHL BIO

EHL BIO is a biotechnology company dedicated to advancing human health through stem cell-based regenerative medicine. Through scientific research into the body's innate capacity for cellular self-recovery, it develops new approaches to aging and disease. By combining premium healthcare with advanced biotechnology, EHL BIO delivers solutions for healthier, more vital lives.