Back to resultsVitiligo Skin Transplantation (MKTP)
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Melanocyte-keratinocyte transplantation procedure (MKTP)
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, skin transplantation, non-cultured, melanocyte, surgery
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years old
- Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Exclusion Criteria:
- Female patients who are breastfeeding, pregnant, or planning to become pregnant
- Patients with a history of developing vitiligo or keloids at sites of trauma
- Patients self-reported as having HIV or Hepatitis C
- Patients self-reported as having uncontrolled Diabetes Mellitus
- The investigator feels the patient should not participate in the study for any reason
Sites / Locations
- Henry Ford Medical Center, New Center One
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MKTP treatment
Arm Description
subject will undergo MKTP
Outcomes
Primary Outcome Measures
effectiveness of MKTP in treating vitiligo
Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).
Secondary Outcome Measures
safety of MKTP in treating vitiligo
Assessed by frequency of adverse events, including, scarring, infection, etc.
Full Information
NCT ID
NCT00830713
First Posted
January 27, 2009
Last Updated
September 4, 2012
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT00830713
Brief Title
Vitiligo Skin Transplantation
Acronym
MKTP
Official Title
Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
vitiligo, skin transplantation, non-cultured, melanocyte, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MKTP treatment
Arm Type
Experimental
Arm Description
subject will undergo MKTP
Intervention Type
Procedure
Intervention Name(s)
Melanocyte-keratinocyte transplantation procedure (MKTP)
Intervention Description
skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color.
Primary Outcome Measure Information:
Title
effectiveness of MKTP in treating vitiligo
Description
Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
safety of MKTP in treating vitiligo
Description
Assessed by frequency of adverse events, including, scarring, infection, etc.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years old
Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
Agree to follow and undergo all study-related procedures
Exclusion Criteria:
Female patients who are breastfeeding, pregnant, or planning to become pregnant
Patients with a history of developing vitiligo or keloids at sites of trauma
Patients self-reported as having HIV or Hepatitis C
Patients self-reported as having uncontrolled Diabetes Mellitus
The investigator feels the patient should not participate in the study for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat H Hamzavi, MD
Organizational Affiliation
Henry Ford Health Systems Dermatology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Medical Center, New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15492183
Citation
Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5. doi: 10.1001/archderm.140.10.1211.
Results Reference
background
PubMed Identifier
16207186
Citation
Mulekar SV. Long-term follow-up study of 142 patients with vitiligo vulgaris treated by autologous, non-cultured melanocyte-keratinocyte cell transplantation. Int J Dermatol. 2005 Oct;44(10):841-5. doi: 10.1111/j.1365-4632.2005.02226.x.
Results Reference
background
Learn more about this trial
Vitiligo Skin Transplantation
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