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Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

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ClinicalTrials.gov Identifier: NCT00631865
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
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Brief Summary:
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.

Condition or disease Intervention/treatment Phase
Vitiligo Biological: Melanocyte transplantation Phase 3

Detailed Description:

Vitiligo is a pigmentation disorder in which white patches of skin appear on different parts of the body. Histologically it is characterized by absence of melanocytes along the epidermal basal layer.

Using cell suspension with non-cultured melanocytes which injected into blister of depigmented lesion, a success rate of 85% was reported for repigmentation. However there are some limitations in this technique: the induction of blister is limited to several sites of the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral melanocytes and leakage of suspension out of the blister. To reduce these problems, in this study we will inject melanocytes directly to epidermis.

A shaved biopsy specimen (about 1 cm2) is taken from the patient's normally pigmented area under local anesthesia (lidocaine hydrochloride 20 mg/ml). The specimens are incubated in 0.25% trypsin solution for 15 minutes at 37°C 0.02% EDTA solution for 10 minutes. Then epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37C for 3-5 minutes. Well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Study Start Date : February 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
Experimental: cell transplantation group
Epidermal Cell transplantation in patients with vitiligo
 Biological: Melanocyte transplantation
Injection of melanocytes directly in Epidermis
Other Names:
  • cell therapy
  • cell transplantation


Outcome Measures
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Primary Outcome Measures :
  1. percentage of repigmentation [ Time Frame: 2 and 4 weeks after transplantation ]

Secondary Outcome Measures :
  1. stability of the achieved repigmentation [ Time Frame: 6 months after transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 12 years
  • Stable form of vitiligo (no increase in the size of the lesion for at least one year)
  • No use of immunosuppressive & cytotoxic drugs at least for past 6 months

Exclusion Criteria:

  • Pregnant patients
  • Patients with active disease
  • Infection at the recipient site
  • Evidence of köebner in the past
  • Keloidal tendencies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631865


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 1665659911
Sponsors and Collaborators
Royan Institute
Investigators
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Principal Investigator: Hossein Baharvand, PhD Head of Royan stem cell department
Principal Investigator: Saeeid Shafieian, MD Firoozgar Hospital
Study Director: Nasser Aghdami, MD., PhD Head of Royan transplantation Lab
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT00631865    
Other Study ID Numbers: Royan-skin-001
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: February 2009
Keywords provided by Royan Institute:
melanocytes
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases