A single-arm open-label clinical trial of autologous epidermal cell transplantation for stable vitiligo: A 30-month follow-up.

BACKGROUND: Recently, we introduced intralesional injection of autologous epidermal cells as a safe and feasible approach for transplantation in patients with stable vitiligo. This approach resulted in less pain during and after the procedure, no scarring or cobblestone formation at the recipient site, and was more feasible to perform on curved surfaces such as joints, lips, eyelids, ears, and face. OBJECTIVE: In this study, we aimed to investigate the long-term efficacy and safety of this transplantation technique. METHODS: In this open-label and single-arm clinical trial, we enrolled 300 patients with stable vitiligo. We obtained a partial thickness normo-pigmented skin specimen from the patients' thigh-buttock junction with an area of one tenth to one third of the recipient site area. The epidermal cell suspension was prepared by processing the autologous skin specimen. We injected the cell suspension into 1060 vitiligo patches in 300 patients. Patients did not use any adjuvant phototherapy during the study. An experienced dermatologist and patients respectively defined the repigmentation score and self-assessment score at regular follow-up visits for up to 30 months after treatment. The scores represented the repigmentation percentage as follows: 0 (0), I (1%-24%), II (25%-49%), III (50%-74%), and IV (75%-100%). RESULTS: The mean repigmentation score at 3 months post-transplantation was 1.12±0.73. A significant upward trend existed in the mean repigmentation score until 9 months after cell transplantation, when the mean repigmentation score reached to 1.98±1.20. At 9 months after treatment, repigmentation of >50% was obtained in 32.2% of treated patches. Acquired repigmentation remained stable in 79.3% of treated patches during the follow-up period. The number of received cells per cm2 positively influenced the repigmentation score. Patches located on face, neck and trunk showed significantly higher response to the treatment. CONCLUSION: The results of our study demonstrated efficacy and safety of autologus epidermal cell transplantation on repigmentation of vitiligo patches. The achieved repigmentation was stable in the majority of treated patches during the follow-up period.

Effect of vitamin D3 supplementation on TNF-α serum level and disease activity index in Iranian IBD patients.

AIM: The aim of the study was to assess the effectiveness of vitamin D3 [1, 25(OH)2D3] treatment in IBD with regard to tumor necrosis factor-alpha (TNF-α) serum level and clinical disease activity index (CDAI). BACKGROUND: Vitamin D has immune-regulatory functions in experimental inflammatory bowel disease (IBD) and vitamin D deficiency is common in IBD patients. PATIENTS AND METHODS: This was a randomized clinical trial on 108 IBD patients with serum 25-OHD levels less than 30ng/ml, which divided into vitamin D and control groups. Vitamin D group received 50000 IU vitamin D3 for 12 weeks. Before and after the study, TNF-α and 25-OHD serum levels were measured by ELISA method. Data were analyzed using paired t-test, chi-square test and Spearman correlation coefficient. P-values ​​less than 0.05 were considered statistically significant. RESULTS: Before the intervention no significant difference was found between baseline characteristics and TNF-α serum level of two groups. After intervention TNF-α serum level reduced but this reduction was not statistically significant (p= 0.07, 95% CI: -0.45 to 8.14). The mean serum 25-OHD level of vitamin D increased from 15.54 to 67.89, which was statistically significant (p= 0.00, 95% CI: -61.40 to -43.30). TNF-α level was also associated significantly with CDAI before (Spearman's rho: 0.3, p<0.0001) and after (Spearman's rho: 0.27, P=0.01) intervention. CONCLUSION: Oral supplementation vitamin D3 significantly increased serum vitamin D levels and insignificantly reduced serum TNF-α level. More studies with larger samples would be beneficial to assess vitamin D3 supplementation efficient effect in IBD.