Atopic dermatitis, commonly referred to as AD, is a common skin condition that affects people of all ages. It is characterized by red and itchy skin, which can become inflamed upon scratching. The condition is considered to be chronic in nature, with symptoms that may last for several months or years and are often exacerbated by environmental triggers.
This condition has become a major public health concern, affecting up to 20% of children and 3-10% of adults. The causes of AD are complex and involve a combination of genetic, immunologic, and environmental factors. Currently, Atopic dermatitis (AD) is largely managed with topical over-the-counter corticosteroids and calcineurin inhibitors, as well as prescription topical steroids and non-steroidal ointments to reduce inflammation. Despite this approach, many patients find their AD difficult to manage.
Treatments are often not effective enough and they can produce common side effects such as skin thinning and irritation, which can in turn lead to further AD exacerbations. Furthermore, while systemic treatments including cyclosporine have been approved for severe cases of AD, they tend to be costly and require constant monitoring. Thus, there is a growing need for additional therapies that are both effective and safe in the treatment of AD.
Stem cell therapy presents an opportunity to restore the skin’s barrier function in individuals with atopic dermatitis. This therapy helps to reduce inflammation and promote wound healing, ultimately improving the condition of the skin. Stem cells accumulate where they are needed most, delivering better results than conventional treatments such as corticosteroids or topical immunomodulators.
While research is ongoing, studies have demonstrated that when applied topically or injected directly into affected areas, stem cell therapy provides significant clinical improvement with few or no side effects. As a result, it is considered safe and effective in treating this common skin disorder.
A study, Clinical Trial of Human Umbilical Cord Blood-Derived Stem Cells for the Treatment of Moderate-to-Severe Atopic Dermatitis: Phase I/IIa Studies, looked into the potential of stem cell therapy for treating AD.
Results of the Study
The Phase 1 study was focused on evaluating the safety of human umbilical cord-derived mesenchymal stem cells hUCB-MSCs against moderate-to-severe atopic dermatitis over a 4 week period. In the subsequent Phase 2a trial, an open-label, double-blind, randomized controlled protocol was used to assess the efficacy and safety of hUCB-MSCs in a 12-week period. A total of 34 participants (7 for phase I and 27 for phase IIa) were selected. Participants were evaluated every 2 weeks after receiving injections under the skin of hUCB-MSCs at two doses of either 2.5 x 107 cells (low) or 5.0 x 107 cells (high).
Throughout the course of the studies, patients were closely monitored during weekly visits for phase 1 or biweekly visits for phase 2a with observation time post injection. At completion, efficacy was measured by the Eczema Area & Severity Index (EASI), Investigator’s Global Assessment (IGA), and Scoring Atopic Dermatitis (SCORAD). The additional outcome parameter looked at was participant number showing 50% reduction in EASI or SCORAD score.
Analysis showed a dose-dependent improvement in AD occurrence – 55% of patients in the high dose group experienced a reduction in their Eczema Area and Severity Index score by 50%. Additionally, Investigator’s Global Assessment score and Severity Scoring for Atopic Dermatitis decreased by 33% and 50%, respectively. Pruritus was reduced by 58%. Blood biomarkers were also downregulated as a result of treatment. Most importantly, no serious adverse events occurred and the trial was not interrupted due to adverse effects. This is the first study that provides evidence of MSCs’ efficacy against AD.
The evaluation of hUCB-MSCs as a stem cell therapy for patients with AD was remarkable. This single treatment showed consistent efficacy across various criteria and scoring parameters. hUCB-MSCs quickly relieved pruritus, which is one of the most common symptoms of AD, leading to better quality of life for the patient.
Results showed an increase in effectiveness when using a higher dose or multiple infusions of hUCB-MSCs. Of those surveyed over the phone, 12 out of 16 patients indicated their intent to receive further treatment with hUCB-MSCs after responding positively to its effects on reducing pruritus and insomnia shortly after administration of the study drug.
Stem cell therapy can be an effective tool against atopic dermatitis as it can help promote the healing of damaged skin and reduce inflammation. Through these significant effects, this form of therapy could help improve symptoms of the condition while also improving quality of life in patients living with atopic dermatitis. Further investigation is needed in this field to expand our understanding of the treatments efficacy and safety, but current studies suggest great potential for the use of stem cell therapy in treating this condition.