Trial reportStem cell research & therapy2025
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.
Trial report in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04137562 (A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Who cites it
1 citing paper in PubMed.
- Targeting macrophage polarization: mechanisms and potential of mesenchymal stromal/stem cells therapy in acne treatment- a narrative review.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundAtopic 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.
methodsThis 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.
resultsStatistically 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 change in TARC levels from baseline to week 16 was significantly different between the treatment and placebo groups.
conclusionsAtMSC therapy improved moderate to severe AD, offering a promising treatment option with potential applications in chronic inflammatory diseases. Further investigation, including double-blind phase 3 trials, is needed to confirm these findings and explore additional biomarkers.
trial registrationClinicalTrials.gov, Identifier: NCT04137562; October 21, 2019; https://clinicaltrials.gov/study/NCT04137562 .
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