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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01822379
• Other study ID #: IRB #6121
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: May 12, 2010
• Last updated: March 8, 2017
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2017
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Procedure:
• Melanocyte Keratinocyte transplantation
Transplantation of cells prepared with dispase

Locations

Country	Name	City	State
United States	Henry Ford Hospital Department of Dermatology	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pigmentation	Investigator will assess amount of pigmentation at site of procedure.	6 months