Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
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|ClinicalTrials.gov Identifier: NCT01822379|
Recruitment Status : Withdrawn (This study was never initiated.)
First Posted : April 2, 2013
Last Update Posted : March 10, 2017
Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation.
This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Procedure: Melanocyte Keratinocyte transplantation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||diaspase versus trypsin for cell separation|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Will perform cell separation using either diaspase or trypsin|
|Official Title:||Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2012|
Experimental: Cell transplantation
All patients will undergo transplantation of two distinct vitiligo lesions. One lesion will receive cells prepared with trypsin. The other lesion will receive cells prepared with dispase.
Procedure: Melanocyte Keratinocyte transplantation
Transplantation of cells prepared with dispase
- Pigmentation [ Time Frame: 6 months ]Investigator will assess amount of pigmentation at site of procedure.
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): NCT01822379
|United States, Michigan|
|Henry Ford Hospital Department of Dermatology|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Iltefat H Hamzavi, MD||Henry Ford Dermatology|