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

NCT ID: NCT01822379

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-07-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Melanocyte Keratinocyte transplantation

Intervention Type: PROCEDURE

Transplantation of cells prepared with dispase

Interventions

Melanocyte Keratinocyte transplantation

Transplantation of cells prepared with dispase

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Iltefat Hamzavi

Senior Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iltefat H Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Dermatology

Locations

Henry Ford Hospital Department of Dermatology

Detroit, Michigan, United States

Countries

United States

Other Identifiers

IRB #6121

Identifier Type: -

Identifier Source: org_study_id