Vitiligo Skin Transplantation

NCT ID: NCT00830713

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vitiligo

Keywords

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vitiligo skin transplantation non-cultured melanocyte surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MKTP treatment

subject will undergo MKTP

Group Type EXPERIMENTAL

Melanocyte-keratinocyte transplantation procedure (MKTP)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat H Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health Systems Dermatology Department

Locations

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Henry Ford Medical Center, New Center One

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/archderm.140.10.1211.

Reference Type BACKGROUND
PMID: 15492183 (View on PubMed)

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. doi: 10.1111/j.1365-4632.2005.02226.x.

Reference Type BACKGROUND
PMID: 16207186 (View on PubMed)

Other Identifiers

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5385

Identifier Type: -

Identifier Source: org_study_id