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

NCT04374435 | Terminated Results DMC FDA Device

• 1 other identifier: 20173518
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Vitiligo

Keywords

Vitiligo; Melanocyte; Keratinocyte; Transplantation; Procedure

Outcome Measures

Primary Outcomes (2)

• Number of Patients Who Had a Percent Change in Body Surface Area in Response Rate to Treatment

  Number of patients who had a percent change in body surface area in response rate to treatment as assessed by photography.

  6 months

• Change in VASI

  Percent change in the transplanted areas as evaluated by VASI (Vitiligo Area Scoring Index). The negative scores mean improvement and positive scores means worsening.

  6 months

Secondary Outcomes (2)

• Percent of Patients That Healed in One Week

  6 months

• Percentage of Patients That Experience Complications

  6 months

Study Arms (3)

MKTP with Surgical Blade

EXPERIMENTAL

The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.

Procedure: MKTP with Surgical blade

MKTP with Negative Pressure Instrument

EXPERIMENTAL

Blister grafting technique with dissociation of the cells was performed in the second arm of the study.

Device: MKTP with Negative Pressure Instrument

Suction blister grafting without cell dissociation

EXPERIMENTAL

In this arm, transplanting the blisters without dissociation of the cells will be conducted.

Device: Suction blister grafting without cell dissociation

Interventions

MKTP with Surgical blade PROCEDURE

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

MKTP with Surgical Blade

MKTP with Negative Pressure Instrument DEVICE

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.

MKTP with Negative Pressure Instrument

Suction blister grafting without cell dissociation DEVICE

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.

Suction blister grafting without cell dissociation

Eligibility Criteria

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

You may qualify if:

• Verified diagnosis of vitiligo by a board-certified dermatologist
• Candidate for vitiligo treatment as determined by lead researcher
• Has a 5 cm2 area of vitiligo and an area on the upper thigh that is not affected by the disease
• Over 18 years of age at the time of signing the informed consent form
• Ability to understand, abide by and participate in study procedures

You may not qualify if:

• Inability to understand or abide by instructions for participation in study and procedure
• Pregnant or lactating women
• Less than 18 years old at the time of signing the informed consent form
• Current use of tobacco products or within 1 month prior to procedure date
• History of coagulation disorder, platelet dysfunction disorder, platelet count less than \<150,000 platelets per microliter
• History of poor wound healing or condition that would compromise optimal healing of graft site as deemed by lead researcher
• History of keloids

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (2)

• Shiu J, Zhang L, Lentsch G, Flesher JL, Jin S, Polleys C, Jo SJ, Mizzoni C, Mobasher P, Kwan J, Rius-Diaz F, Tromberg BJ, Georgakoudi I, Nie Q, Balu M, Ganesan AK. Multimodal analyses of vitiligo skin identify tissue characteristics of stable disease. JCI Insight. 2022 Jul 8;7(13):e154585. doi: 10.1172/jci.insight.154585.

  PMID: 35653192 RESULT

• Mobasher P, Shiu J, Lentsch G, Ganesan AK. Comparing the Efficacy of 2 Different Harvesting Techniques for Melanocyte Keratinocyte Transplantation in Vitiligo. Dermatol Surg. 2021 May 1;47(5):732-733. doi: 10.1097/DSS.0000000000002922. No abstract available.

  PMID: 33905400 RESULT

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anand Ganesan, MD, Professor
• Organization: University of California, Irvine

aganesan@uci.edu

949-824-0606

Study Officials

• Anand K Ganesan, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The patients were not randomly assigned, rather each arm has been done sequentially with a retrospective comparison of the results.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The investigators have completed two arms of the study in sequential study design (each arm has done individually with no random assignment). An exploratory third arm was initiated but then suspended.

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: May 5, 2020
• Study Start: September 29, 2017
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)