Vitiligo Skin Transplantation

Vitiligo Clinical Trial

— MKTP  

Official title:

Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830713
• Other study ID #: 5385
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2009
• Last updated: September 4, 2012
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: May 2010
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be at least 18 years old

2. Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months

3. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form

4. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Female patients who are breastfeeding, pregnant, or planning to become pregnant

2. Patients with a history of developing vitiligo or keloids 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Procedure:
• Melanocyte-keratinocyte transplantation procedure (MKTP)
skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color.

Locations

Country	Name	City	State
United States	Henry Ford Medical Center, New Center One	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mulekar SV. Long-term follow-up study of 142 patients with vitiligo vulgaris treated by autologous, non-cultured melanocyte-keratinocyte cell transplantation. Int J Dermatol. 2005 Oct;44(10):841-5. — View Citation

Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of MKTP in treating vitiligo	Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).	6 months	No
Secondary	safety of MKTP in treating vitiligo	Assessed by frequency of adverse events, including, scarring, infection, etc.	6 months	Yes

External Links

•   Website of the developer of the procedure