Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft for Stable Non-Segmental Vitiligo Lesions

NCT ID: NCT06619184

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-09-30

Brief Summary

Vitiligo is an acquired pigmentation disorder due to loss of melanocytes characterized by depigmentation macules or patches. One type of this disease is nonsegmental vitiligo (NSV). Until now, there is no satisfactory treatment for vitiligo. Vitiligo therapies are medical therapy include topical and systemic therapy, phototherapy as well as surgery. Surgical treatment is indicated in stable vitiligo, which is not responding to medical treatment. This procedure consists of tissue grafting and cellular transplantation. Mini punch graft (MPG) is the most frequently performed tissue transplantation technique, while cellular transplantation from autologous noncultured extracted hair follicle outer root sheath cell suspension (NCEHFORSCS) containing melanocyte stem cells, is currently a promising option.

Detailed Description

Current NSV treatments can be considered suboptimal and leading to decreased patient's quality of life due to the emotional burden of therapy dissatisfaction. When a stable NSV is not responding to medical therapy, surgery may be a useful treatment approach. All surgical techniques in vitiligo treatment share the same principle: transferring autologous melanocytes from a donor to repopulate melanocytes in the depigmented area that lacks a reservoir or fails to activate melanocytes in the outer root sheath (ORS) of hair follicles. MPG as the most frequently performed tissue transplantation technique transferred the epidermal melanocyte to vitiligo lesion, while NCEHFORSCS provides melanocytes with better properties and contains melanocyte stem cells. The advantages of melanocytes from ORS compared to epidermal are the follicular melanocyte:keratinocyte ratio consists of one melanocyte for every five keratinocytes or 1:5 in the hair bulb, melanocytes are more dendritic, have larger melanosomes, and have the potential to produce more melanin pigment. Due to these properties, hair follicles can be a better source of melanocytes than epidermis in the delivery of cellular transplantation-based therapy for vitiligo therapy. Research comparing the effectiveness of the two procedures has never been conducted in Indonesia, even though the incidence of vitiligo is quite high and the success of therapy is still not optimal. So the purpose of this study is to compare the effectiveness of the two procedures in NSV patient.

Conditions

Non Segmental Vitiligo

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NCEHFORSCS transplantation and MPG procedure

The research was conducted on 21 participants.

Two vitiligo lesions from each participant that met the inclusion and exclusion criteria were treated with NCEHFORSCS transplantation and MPG procedure followed by observation of repigmentation.

The participants were informed that a series of procedures would be performed, including hair follicle extraction using the follicle unit extraction (FUE) procedure, followed by the preparation of NCEHFORSCS in PT Prodia StemCell Indonesia (ProSTEM®) laboratory, and transplantation of NCEHFORSCS on one VNS lesion while MPG procedure was performed on another lesion.

Follow-up was carried out at the 2nd week, 4th week, 8th week, 12th week, and 16th week after the NCEHFORSCS transplantation and MPG procedures to assess repigmentation of the lesions and side effects of the procedures.

Group Type: EXPERIMENTAL

NCEHFORSCS transplantation

Intervention Type: PROCEDURE

One vitiligo lesion of participans treated with NCEHFORSCS transplantation including follicle unit extraction (FUE) procedure from the occipital area, laboratory procedure for preparation of cell suspension, and transplantation of NCEHFORSCS.

MPG procedure

Intervention Type: PROCEDURE

Another vitiligo lesion treated with MPG procedure

Follow up The dressing was removed by the researcher on day 8 The participants were asked to attend for follow-up at the clinic on week 2, 4, 8, 12, and 16 after the two procedure were done.

At 2, 4, 8, 12 and 16 weeks of follow-up visits, any possible complications were evaluated and digital photographs of the lesions were taken for evaluating the two procedure efficacy using its parameter: appearance of repigmentation (AOR), total number of repigmentation NSV lesions, extent area of repigmentation, and color match

Interventions

NCEHFORSCS transplantation

One vitiligo lesion of participans treated with NCEHFORSCS transplantation including follicle unit extraction (FUE) procedure from the occipital area, laboratory procedure for preparation of cell suspension, and transplantation of NCEHFORSCS.

Intervention Type: PROCEDURE

MPG procedure

Another vitiligo lesion treated with MPG procedure

Follow up The dressing was removed by the researcher on day 8 The participants were asked to attend for follow-up at the clinic on week 2, 4, 8, 12, and 16 after the two procedure were done.

At 2, 4, 8, 12 and 16 weeks of follow-up visits, any possible complications were evaluated and digital photographs of the lesions were taken for evaluating the two procedure efficacy using its parameter: appearance of repigmentation (AOR), total number of repigmentation NSV lesions, extent area of repigmentation, and color match

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Non-Segmental Vitiligo patients

2. Minimal 1-year duration of stability

3. Age between 18-70 years

4. Having at least two vitiligo lesions for NCEHFORSCS transplantation and MPG procedure

The two vitiligo lesions to be treated must meet the following criteria:

1. Have similar size, minimum of 1 cm² and a maximum of 20 cm²

2. The distance between the two lesions at least 1 cm

3. Location of the lesions must have a relatively similar distribution of hair follicles

4. Not located on the palms, soles, or penis

Exclusion Criteria

1. Pregnant

2. Active vitiligo

3. Mixed vitiligo

4. Presence of new lesions

5. History of hypertrophic scars and keloids

6. History of bleeding disorders

7. Other active autoimmune diseases

8. History of wound healing disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reiva Farah Dwiyana, MD

Role: PRINCIPAL_INVESTIGATOR

Universitas Padjadjaran

Locations

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

DV-202407.01.

Identifier Type: -

Identifier Source: org_study_id