Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo
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|ClinicalTrials.gov Identifier: NCT04374435|
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
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 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. We will exclude individuals less than 18 years old for the study as we believe it would be difficult for these subjects to tolerate the melanocyte keratinocyte transplant procedure. Patients 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:
- MKTP with Surgical Blade
- MKTP with Negative Pressure Instrument (suction blistering device).
- Suction blister grafting without cell dissociation utilizing Cellutome (a device used for treating chronic burn wounds)
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Procedure: MKTP with Surgical blade Device: MKTP with Negative Pressure Instrument Device: Suction blister grafting without cell dissociation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||The investigators have completed two arms of the study in sequential study design (each arm has done individually with no random assignment). The third arm has begun enrolling.|
|Masking:||None (Open Label)|
|Masking Description:||The patients were not randomly assigned, rather each arm has been done sequentially with a retrospective comparison of the results.|
|Official Title:||Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo|
|Actual Study Start Date :||September 29, 2017|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: MKTP with Surgical Blade
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
In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
Experimental: MKTP with Negative Pressure Instrument
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
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.
Experimental: Suction blister grafting without cell dissociation
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
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.
- Percentage of change in the transplanted areas [ Time Frame: 6 months ]Percentage of change in the transplanted areas will be evaluated by photography
- Percentage of change in the transplanted areas in the transplanted areas [ Time Frame: 6 months ]Percentage of change in the transplanted areas will be evaluated by VASI (Vitiligo Area Scoring Index). The minimum value is 0 and maximum value is 100. and higher scores mean worse outcome.
- Time of healing [ Time Frame: 6 months ]The investigator will evaluate how long it took the patient to heal at both the donor and graft site
- Rate of Complication [ Time Frame: 6 months ]The investigator will record the rate of complications of the procedure itself.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374435
|Contact: Anand K Ganesan, MD, PhD||(949) firstname.lastname@example.org|
|Contact: Pezhman Mobasher, MD||(949) email@example.com|
|Principal Investigator:||Anand K Ganesan, MD, PhD||University of California, Irvine|