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

Primary Purpose

Vitiligo

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Melanocyte Keratinocyte transplantation

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Henry Ford Hospital Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cell transplantation

Arm Description

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.

Outcomes

Primary Outcome Measures

Pigmentation

Investigator will assess amount of pigmentation at site of procedure.

Secondary Outcome Measures

Full Information

NCT ID

NCT01822379

First Posted

May 12, 2010

Last Updated

March 8, 2017

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT01822379

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Why Stopped

This study was never initiated.

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

diaspase versus trypsin for cell separation

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Will perform cell separation using either diaspase or trypsin

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cell transplantation

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Melanocyte Keratinocyte transplantation

Intervention Description

Transplantation of cells prepared with dispase

Primary Outcome Measure Information:

Title

Pigmentation

Description

Investigator will assess amount of pigmentation at site of procedure.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iltefat H Hamzavi, MD

Organizational Affiliation

Henry Ford Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henry Ford Hospital Department of Dermatology

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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