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Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo

NCT04374435 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-09-05

Study results available
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Summary

Vitiligo is a dermatologic disease characterized by depigmentation of the skin. While the loss of melanocytes observed in vitiligo is driven by the immune system, repigmentation of the skin that occurs during UV light treatment is driven by melanocytes that migrate out of the hair follicle and into the epidermis or the activation of stem cells within the epidermis. Unfortunately, some skin areas affected by vitiligo have very few hair follicle melanocytes and an indeterminate number of epidermal melanocytes and therefore unable to respond to light therapy.

This pilot study seeks to examine the relative efficacy of different harvesting methods for the melanocyte keratinocyte transplant procedure (MKTP) in the treatment of vitiligo.

In addition, this study will analyze the tissue of excess tissue harvested during the procedure to identify distinct cellular and molecular features of chronic vitiligo.

Patients in Dr. Ganesan's clinic at the UCI (University of California, Irvine) Department of Dermatology will be approached for participation in the study. The study will include both men and women and will not be limited by race or ethnicity. The investigators will exclude individuals less than 18 years old for the study as the investigators believe it would be difficult for these subjects to tolerate the melanocyte keratinocyte transplant procedure. Participants will be offered a melanocyte keratinocyte transplant procedure with one of the three different tissue harvesting methods (a blade, suction blister) and the method without dissociation (Cellutome).

This study has three arms:

1. MKTP with Surgical Blade
2. MKTP with Negative Pressure Instrument (suction blistering device).
3. Suction blister grafting without cell dissociation utilizing Cellutome (a device used for treating chronic burn wounds)

Conditions

  • Vitiligo

Interventions

PROCEDURE

MKTP with Surgical blade

In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated

DEVICE

MKTP with Negative Pressure Instrument

In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.

DEVICE

Suction blister grafting without cell dissociation

In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Anand K Ganesan, MD, PhD · University of California, Irvine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2021-12-01
Completion
2022-05-01
FDA Device
Yes

Countries

  • United States

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 NCT04374435 on ClinicalTrials.gov