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Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial.

ABSTRACT: Importance:Surgical interventions, notably noncultured epidermal suspension (NCES), are the next line of treatment in patients with vitiligo who fail to respond to medical therapy. Noncultured epidermal suspension is usually performed in patients with vitiligo with duration of clinical stability (DS) of 12 months or longer because DS is a vital parameter in determining outcome of NCES. In this pilot study, we planned to assess the efficacy of a novel combination of noncultured epidermal cell suspension and noncultured dermal cell suspension (NCES and NDCS) in patients with vitiligo with shorter DS (3-6 months). Objective:To compare the efficacy of transplantation of NCES and NDCS vs NCES alone in patients with vitiligo with DS of 3 to 6 months. Design, Setting, and Participants:A single-center randomized clinical trial including 40 patients with focal, segmental, or generalized vitiligo with DS of 3 to 6 months or more than 12 months was carried out. Based on DS, 2 groups including 20 patients each were recruited (DS in group 1, 3 to 6 months; DS in group 2, more than 12 months). Each group was further randomized into 2 subgroups, A and B. Intervention:Patients in subgroups 1A and 2A underwent NCES alone, whereas patients in subgroups 1B and 2B underwent NCES and NDCS. Main Outcomes and Measures:Extent of repigmentation, color match, and pattern of repigmentation at 24 weeks. Results:Of the 40 study participants, mean (SD) age was 24.9 (4.0) years and 24 (60%) were women; in group 1 with DS for 3 to 6 months, more than 75% repigmentation at 24 weeks was observed in all 10 patients in subgroup 1B (NCES and NDCS) compared with 3 of 10 patients in subgroup 1A (NCES) (100% vs 30%, P?=?.003). In group 2 (DS?>?12 months), the same was observed in 6 of 10 patients in subgroup 2A and 7 of 10 patients in subgroup 2B (NCES) (60% vs 70%, P?>?.99). The 2 groups and subgroups did not show any significant differences with respect to color matching and pattern of repigmentation. Conclusions and Relevance:Combination of NCES and NDCS resulted in excellent response in patients with vitiligo with shorter duration of clinical stability compared with NCES alone. This combination may be used early in the course of stable vitiligo without waiting for a period of 12 months or more since last clinical activity. Trial Registration:ClinicalTrials.gov identifier: NCT03013049.

SUBMITTER: Thakur V

PROVIDER: S-EPMC6439545 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial.

Thakur Vishal V Kumar Sheetanshu S Kumaran Muthu Sendhil MS Kaushik Hitaishi H Srivastava Niharika N Parsad Davinder D

JAMA dermatology 20190201 2

<h4>Importance</h4>Surgical interventions, notably noncultured epidermal suspension (NCES), are the next line of treatment in patients with vitiligo who fail to respond to medical therapy. Noncultured epidermal suspension is usually performed in patients with vitiligo with duration of clinical stability (DS) of 12 months or longer because DS is a vital parameter in determining outcome of NCES. In this pilot study, we planned to assess the efficacy of a novel combination of noncultured epidermal ...[more]

PMID: 30601885

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Project description:Importance:Epidermal cell suspension (ECS) and follicular cell suspension (FCS) are successful surgical modalities for the treatment of stable vitiligo. However, repigmentation in generalized and acrofacial vitiligo and over acral or bony sites (eg, elbows, knees, iliac crests, and malleoli), which are difficult to treat, is challenging. Objective:To study the efficacy of transplanting a combination of autologous, noncultured ECS and FCS (ECS?+?FCS) compared with ECS alone in stable vitiligo. Design, Setting, and Participants:A prospective, observer-blinded, active-controlled, randomized clinical trial was conducted at a tertiary care hospital, with treatment administered as an outpatient procedure. Thirty participants who had stable vitiligo with symmetrical lesions were recruited between October 18, 2013, and October 28, 2016. All of the lesions were resistant to medical modalities with minimum lesional stability of 1 year. Intent-to-treat analysis was used. Interventions:ECS?+?FCS was prepared by mixing equal amounts (in cell number) of FCS with ECS. After manual dermabrasion, ECS was applied to 1 lesion and ECS?+?FCS was applied to the anatomically based paired lesion of the same patient. No adjuvant treatment was given. Main Outcomes and Measures:Patients were followed up at 4, 8, and 16 weeks by a blinded observer and extent of repigmentation, color match, pattern of repigmentation, patient satisfaction and complications were noted. Both the visual and the computerized image analysis methods were used for outcome assessment. Cell suspensions were assessed post hoc for OCT4+ stem cell counts using flow cytometry; expression of stem cell factor and basic fibroblast growth factor was evaluated using quantitative relative messenger RNA expression. Results:Of the 30 patients included in the study, 18 (60%) were women; mean (SD) age was 23.4 (6.4) years. Seventy-four percent of the lesions (62 of 84) were difficult-to-treat vitiligo. ECS?+?FCS showed superior repigmentation outcomes compared with ECS: extent (76% vs 57%, P?<?.001), rapidity (48% vs 31%, P?=?.001), color match (73% vs 61%, P?<?.001), and patient satisfaction (mean [SD] patient global assessment score, 23.30 [6.89] vs 20.81 [6.61], P?=?.047). Melanocyte stem cell counts (2% in ECS?+?FCS vs 0.5% in ECS) as well as expression of basic fibroblast growth factor (11.8-fold) and stem cell factor (6.0-fold) were higher in ECS?+?FCS suspension (P<.05 for both). Conclusions and Relevance:The findings from this study establish ECS?+?FCS as a novel approach in vitiligo surgery for attaining good to excellent repigmentation in a short period with good color match, even in difficult-to-treat vitiligo. Trial Registration:ctri.nic.in Identifier: CTRI/2017/05/008692.

Dataset Information

Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial.

Publications

Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial.

Similar Datasets

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