Clinical trial NCT06619184: Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft for Stable Non-Segmental Vitiligo Lesions
Official title: Comparison of The Effectiveness Between Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft in Non-Segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Segmental Vitiligo
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Appearance of repigmentation (AOR)
timeFrame: 4 months
measure: Total number of repigmentation non-segmental vitiligo (NSV) lesions
timeFrame: 4 months
measure: Extent area of repigmentation
timeFrame: 4 months
measure: Color match
timeFrame: 4 months
Secondary outcomes:
measure: Complication
timeFrame: 4 months
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: Jawa Barat
Study officials:
affiliation: Universitas Padjadjaran
name: Reiva Farah Dwiyana, MD
role: PRINCIPAL_INVESTIGATOR
References: