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

NCT01822379 | Withdrawn Phase 2 DMC

• 1 other identifier: IRB #6121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pigmentation

  Investigator will assess amount of pigmentation at site of procedure.

  6 months

Study Arms (1)

Cell transplantation

EXPERIMENTAL

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

Interventions

Melanocyte Keratinocyte transplantation PROCEDURE

Transplantation of cells prepared with dispase

Cell transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years old
• Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
• Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
• 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

You may not qualify if:

• Female patients self-reported to be lactating, pregnant, or planning to become pregnant
• Patients with a history of developing vitiligo or hypertrophic scars 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
• Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
• Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
• Patients with vitiligo affecting greater than 30% of their body surface area

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital Department of Dermatology

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iltefat H Hamzavi, MD

  Henry Ford Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Will perform cell separation using either diaspase or trypsin
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician

Model Details: diaspase versus trypsin for cell separation

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: April 2, 2013
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

US (1)