A Novel Surgical Method in the Treatment of Unstable Vitiligo

Summary

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.

Conditions

• Vitiligo

Interventions

PROCEDURE

Non cultured epidermal cell suspension

Non cultured epidermal cell suspension Split thickness skin specimen will be transferred under aseptic conditions to a container with normal salineand transferred to laboratory. There, the skin graft will be transferred to Trypsin-EDTA solution (0.25% trypsin and 0.02% EDTA) in a Petri dish and incubated overnight at 4°C in 5% CO2 to separate the epidermis from the dermis.Afterwards, the Trypsin-EDTA solution will be removed and PBS will be added and pipetted well so as to separate the cells from the tissue.The suspension will be centrifuged at 1000 rpm for 5 minutes.The supernatant will then be discarded and Phosphate buffer saline is added to make suspension of non-cultured epidermal cells.

PROCEDURE

Non cultured dermal cell suspension

Non-cultured Dermal Cell Suspension Skin punch will be collected in phosphate buffer saline (PBS) with antibiotics (penicillin and streptomycin). The epidermis will be cut off from dermis carefully using a surgical blade (Epidermal part will be used for the epidermal cell suspension). Dermis will be then cut into small pieces and incubated in collagenase (1mg/ml) overnight at room temperature. Next day content will be diluted with PBS and centrifuged at 1000rpm for 5 minutes. Pellet will be washed three times with PBS to remove collagenase activity. Phosphate buffer saline is added to make suspension of non-cultured dermal cells and will be used for the autologous transplantation.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• India

Study Locations