A Comparative Study Between Autologous Non Cultured Epidermal Cell Suspension Versus Combination of Autologous Non Cultured Epidermal Cell Suspension and Non Cultured Dermal Cell Suspension in Stable Vitiligo
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- extent of repigmentation
研究概览
简要总结
Vitiligo is a complex disease causing a selective, often progressive, loss of functioning melanocytes from epidermal basal layer resulting in white patches on the skin and occasionally mucosae. Worldwide prevalence of vitiligo is around 1% whereas in India it is around 3-4% ranging from 0.46% to 8.8%.
Etiopathogenesis of vitiligo is multifactorial consisting of genetic, immunological and environmental factors. Environmental and genetic factors act in concert to destroy melanocytes. Reactive oxygen species (ROS) play important roles in vitiligo pathology,but the autoimmune pathogenesis has been proposed as one of the main causes of vitiligo.
Surgical methods, mainly transplantation of non cultured epidermal cell suspension are effective treatment for stable vitiligo. Transplantation of autologous noncultured epidermal cell suspension and non-cultured dermal cell suspension in combination (a mode of cellular grafting technique) is a novel surgical method for the treatment of vitiligo. Cytotoxic CD8+ ( cluster of differentiation 8+) cells in vitiligo perilesions may dictate the fate of transplantation, and strategies against CD8+ T cell activation might be beneficial for patients undergoing melanocyte transplantation. Mesenchymal cells could inhibit T cell proliferation and induce T cell apoptosis. Bartsch first identified and characterized dermal mesenchymal cells (DMCs). They have a multi-lineage differentiation potential into adipocytes, osteocytes and chondrocytes.Vitiligo patients' autologous melanocytes transplantation efficiency may be predicted by perilesional skin-homing CD8+ T cell activities, and the immunoregulatory DMCs might be used as auxiliary agent to improve the efficacy.
This pilot study is planned to compare transplantation of autologous noncultured epidermal cell suspension v/s its combination with non-cultured dermal cell suspension as a novel method in vitiligo surgery in stability of vitiligo with regards to extent of repigmentation, color matching of repigmented area, patient satisfaction and adverse events if any. This is the first study using transplantation of autologous noncultured epidermal cell suspension and non-cultured dermal cell suspension in combination as a new modality in vitiligo surgery.
详细描述
Vitiligo, the most common depigmenting disorder is an 'idiopathic', acquired pigmentary disorder caused by the loss of functional melanocytes from the epidermis. The course of the disease is unpredictable but is often progressive with phases of stabilized depigmentation. It usually begins during childhood or young adulthood. Approximately one third to one half of the patients develops the disease before the age of 20 years. The presence of vitiligo on exposed areas of body leads to social embarrassment, psychological turmoil, and cosmetic disfigurement in those affected.
Its prevalence is 1%, ranging from 0.1 to > 8.8% in different countries of the globe. Both sexes are equally affected although the greater number of reports among females is probably due to the greater social consequences to women and girls affected by this condition.
Treatment options A number of therapeutic options for vitiligo are available but there is still a need for a treatment that is promptly effective. There is no curative treatment for this condition. Management of vitiligo is a real challenge for a dermatologist.
Medical therapies:
Corticosteroids (Topical, intralesional and systemic), Oral mini pulse, PUVA (topical and systemic), NBUVB, calcipotriol and tacrolimus are used most widely. Some of the less commonly used medical modalities include phenylalanine, khellin, topical minoxidil, levamisole and melagenina. Recently oral minocycline was shown to be effective in treating vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinical diagnosis of focal, segmental or generalized vitiligo which has been stable for more than 3 months.
排除标准
- •Age less than 18 years
- •Patient with actively spreading vitiligo
- •Appearance of new lesions
- •History of Koebnerisation
- •History of hypertrophic scars or keloidal tendency
- •Bleeding disorders
- •Patients with unrealistic expectation
结局指标
主要结局
extent of repigmentation
时间窗: 6 months
Repigmentation will be assessed as follows - ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation \>90% Excellent repigmentation
次要结局
- pattern of repigmentation(6 months)
研究者
Davinder Parsad
Professor
Post Graduate Institute of Medical Education and Research, Chandigarh