A Novel Surgical Method in the Treatment of Unstable Vitiligo

NCT03013049 | Unknown DMC

• 1 other identifier: INT/IEC/2016/2675
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• extent of repigmentation

  Repigmentation will be assessed as follows - ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation \>90% Excellent repigmentation

  6 months

Secondary Outcomes (1)

• pattern of repigmentation

  6 months

Study Arms (2)

Non cultured epidermal cell suspension

ACTIVE COMPARATOR

In 20 patients who have stable vitiligo with the duration of stability more than 3 months, non cultured epidermal cell suspension will be done. Patients will be divided into 2 subgroups of 10 patients each of stability duration of 3-6 months and more than 1 year respectively and non cultured epidermal cell suspension will be done.

Procedure: Non cultured epidermal cell suspension

Non cultured dermal cell suspension

EXPERIMENTAL

In 20 patients who have stable vitiligo with the duration of stability more than 3 months, combination of non cultured epidermal cell suspension and non cultured dermal cell suspension will be done. Patients will be divided into 2 subgroups of 10 patients each of stability duration of 3-6 months and more than 1 year respectively and combination of non cultured epidermal cell suspension and non cultured dermal cell suspension will be done.

Procedure: Non cultured epidermal cell suspension; Procedure: Non cultured dermal cell suspension

Interventions

Non cultured epidermal cell suspension PROCEDURE

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.

Non cultured dermal cell suspension; Non cultured epidermal cell suspension

Non cultured dermal cell suspension PROCEDURE

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.

Non cultured dermal cell suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with clinical diagnosis of focal, segmental or generalized vitiligo which has been stable for more than 3 months.

You may not qualify if:

• Age less than 18 years
• Pregnancy
• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• Thakur V, Kumar S, Kumaran MS, Kaushik H, Srivastava N, Parsad D. Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. 2019 Feb 1;155(2):204-210. doi: 10.1001/jamadermatol.2018.4919.

  PMID: 30601885 DERIVED

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Davinder Parsad, MD

CONTACT

9736060361; parsad@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 6, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)