Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo

Phase 2

Withdrawn

• Conditions: Vitiligo
• Interventions: Procedure: Melanocyte Keratinocyte transplantation

• Registration Number: NCT01822379
• Lead Sponsor: Henry Ford Health System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-12
• Primary Completion: 2011-07
• Study Completion: 2012-07
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Be at least 18 years old
2. Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
3. Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
4. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
5. Agree to follow and undergo all study-related procedures

Exclusion Criteria

1. Female patients self-reported to be lactating, pregnant, or planning to become pregnant
2. Patients with a history of developing vitiligo or hypertrophic scars at sites of trauma
3. Patients self-reported as having HIV or Hepatitis C
4. Patients self-reported as having uncontrolled Diabetes Mellitus
5. The investigator feels the patient should not participate in the study for any reason
6. Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
7. Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
8. Patients with vitiligo affecting greater than 30% of their body surface area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cell transplantation	Melanocyte Keratinocyte 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.

Primary Outcome Measures

Name	Time	Method
Pigmentation	6 months	Investigator will assess amount of pigmentation at site of procedure.

Trial Locations

Locations (1)

Henry Ford Hospital Department of Dermatology; 🇺🇸 Detroit, Michigan, United States