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

NCT06619184 | Completed DMC

• 1 other identifier: DV-202407.01.
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Segmental Vitiligo

Outcome Measures

Primary Outcomes (4)

• Appearance of repigmentation (AOR)

  The first appearance of repigmentation in non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure evaluated by blind investigator using dermoscope at weeks 2, -4, -8, -12, and -16

  4 months

• Total number of repigmentation non-segmental vitiligo (NSV) lesions

  Total number of NSV lesions that experienced repigmentation at the 16th week of observation

  4 months

• Extent area of repigmentation

  The repigmentation area percentage level of non-segmental vitiligo (NSV) lesions after NCEHFORSCS transplantation and MPG procedure determine by blind investigator using the digital images. The scores were confirmed by objective measurement of the extent of repigmentation by a digital image analysis system ImageJ® as follow: No repigmentation (0%) Poor repigmentation (0,1-49%) Fair repigmentation (50-74%) Good repigmentation (75-89%) Excellent repigmentation (90-100%)

  4 months

• Color match

  Color match between repigmentation of the lesions and surrounding skin assessed subjectively by a blind investigator using digital photography at week 16 as follows: No repigmentation color Lighter than peri lesion skin color Same as peri lesion skin color Darker than peri lesion skin color

  4 months

Secondary Outcomes (1)

• Complication

  4 months

Study Arms (1)

NCEHFORSCS transplantation and MPG procedure

EXPERIMENTAL

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.

Procedure: NCEHFORSCS transplantation; Procedure: MPG procedure

Interventions

NCEHFORSCS transplantation 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.

NCEHFORSCS transplantation and MPG procedure

MPG procedure 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

NCEHFORSCS transplantation and MPG procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Segmental Vitiligo patients
• Minimal 1-year duration of stability
• Age between 18-70 years
• Having at least two vitiligo lesions for NCEHFORSCS transplantation and MPG procedure
• The two vitiligo lesions to be treated must meet the following criteria:
• Have similar size, minimum of 1 cm² and a maximum of 20 cm²
• The distance between the two lesions at least 1 cm
• Location of the lesions must have a relatively similar distribution of hair follicles
• Not located on the palms, soles, or penis

You may not qualify if:

• Pregnant
• Active vitiligo
• Mixed vitiligo
• Presence of new lesions
• History of hypertrophic scars and keloids
• History of bleeding disorders
• Other active autoimmune diseases
• History of wound healing disorders

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

Study Officials

• Reiva Farah Dwiyana, MD

  Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

ID (1)