Clinical Trial of Human Umbilical Cord Blood-Derived Stem Cells for the Treatment of Moderate-to-Severe Atopic Dermatitis: Phase I/IIa Studies

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This clinical trial by Kim et al. evaluates the safety and efficacy of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) in treating moderate-to-severe atopic dermatitis (AD). AD is a chronic inflammatory skin disease characterized by severe itching and eczematous lesions. Conventional treatments often provide limited relief and have significant side effects. In this trial, 34 adult patients with moderate-to-severe AD were enrolled and received either low dose (2.5 × 10^7) or high dose (5.0 × 10^7) of hUCB-MSCs subcutaneously. The study assessed various clinical endpoints, including Eczema Area and Severity Index (EASI), Investigator’s Global Assessment (IGA), and Severity Scoring for Atopic Dermatitis (SCORAD). Results showed a dose-dependent improvement in AD symptoms, with the high dose group exhibiting a 55% reduction in EASI score. No serious adverse events were reported, highlighting the potential of hUCB-MSCs as a safe and effective therapy for AD.

Atopic dermatitis (AD) is a prevalent chronic inflammatory skin disorder that significantly impacts patients' quality of life. It is characterized by intense itching, dry skin, and inflamed lesions. Traditional treatments, such as topical corticosteroids and systemic immunosuppressants, often offer only temporary relief and can cause adverse effects. As a result, there is a critical need for novel therapeutic approaches that can provide sustained relief with minimal side effects.

This study by Kim et al. investigates the use of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) in treating AD. MSCs have shown promise in preclinical studies due to their immunomodulatory and anti-inflammatory properties. The objective of this clinical trial was to establish the safety and efficacy of hUCB-MSCs in patients with moderate-to-severe AD.

The trial enrolled 34 adult patients, who were randomly allocated to receive either a low dose (2.5 × 10^7 cells) or a high dose (5.0 × 10^7 cells) of hUCB-MSCs subcutaneously. The study's primary endpoints included changes in the Eczema Area and Severity Index (EASI) score, Investigator’s Global Assessment (IGA) score, Severity Scoring for Atopic Dermatitis (SCORAD), and serum biomarkers such as IgE levels and blood eosinophil counts. Patients were followed up for 1 month and 3 months to evaluate the treatment's effects.

The results were promising. A single administration of hUCB-MSCs resulted in dose-dependent improvements in AD symptoms. In the high dose group, 55% of patients achieved a 50% reduction in EASI score. The IGA score and SCORAD score decreased by 33% and 50%, respectively. The high dose group also experienced a significant reduction in pruritus (itching) score by 58%. Additionally, serum IgE levels and blood eosinophil counts were downregulated following treatment. Importantly, no serious adverse events occurred, and none of the patients discontinued the trial due to adverse effects.

These findings suggest that hUCB-MSCs can significantly alleviate AD symptoms by modulating the immune response and reducing inflammation. The trial demonstrated that hUCB-MSCs are safe and well-tolerated, providing a potential new therapeutic option for patients with moderate-to-severe AD.

The therapeutic effects observed in this clinical trial align with Novastem's objectives of using stem cell therapies to regenerate and repair damaged tissues. The immunomodulatory and anti-inflammatory properties of hUCB-MSCs demonstrated in this study suggest that Novastem's stem cell treatments could offer similar benefits for conditions characterized by chronic inflammation and immune dysregulation, such as atopic dermatitis and other autoimmune diseases.

  • Mechanism of Action: hUCB-MSCs modulate immune responses by reducing levels of pro-inflammatory cytokines and serum biomarkers, thereby alleviating AD symptoms.
  • Clinical Benefits: Subcutaneous administration of hUCB-MSCs significantly reduces AD severity, as evidenced by improvements in EASI, IGA, and SCORAD scores, as well as reductions in pruritus and serum IgE levels.
  • Potential for Broad Application: The success of hUCB-MSC therapy in treating AD suggests its applicability to other chronic inflammatory and autoimmune conditions, enhancing the scope of stem cell-based therapies.

#AtopicDermatitis #MesenchymalStemCells #Immunomodulation #SkinInflammation #StemCellTherapy #ChronicInflammation #ClinicalTrial

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