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

October 2, 2024 updated by: Universitas Padjadjaran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40161
        • Hasan Sadikin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance of repigmentation (AOR)
Time Frame: 4 months
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
Time Frame: 4 months
Total number of NSV lesions that experienced repigmentation at the 16th week of observation
4 months
Extent area of repigmentation
Time Frame: 4 months

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
Time Frame: 4 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 4 months
Complication at the location of melanocyte donor and recipient both from the two procedure include secondary infection, milia, scar tissue, rejection, and new vitiligo lesion (Köebnerization) on the donor or recipient site of NCEHFORSCS transplantation and cobblestone appearance at the recipient area of MPG and minimal superficial scar tissue at the MPG donor area.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Principal Investigator: Reiva Farah Dwiyana, MD, Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV-202407.01.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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