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

NCT06619184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Reiva Farah Dwiyana, MD · Universitas Padjadjaran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06619184 on ClinicalTrials.gov