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

Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo

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.

Study Overview

• Status: Withdrawn
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Melanocyte Keratinocyte transplantation

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pigmentation	Investigator will assess amount of pigmentation at site of procedure.	6 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (Estimate): April 2, 2013

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: IRB #6121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No