Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631865
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Royan Institute

March 3, 2008
March 10, 2008
July 20, 2016
February 2009
February 2015   (Final data collection date for primary outcome measure)
percentage of repigmentation [ Time Frame: 2 and 4 weeks after transplantation ]
Same as current
Complete list of historical versions of study NCT00631865 on Archive Site
stability of the achieved repigmentation [ Time Frame: 6 months after transplantation ]
Same as current
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Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.

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.

Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Biological: Melanocyte transplantation
Injection of melanocytes directly in Epidermis
Other Names:
  • cell therapy
  • cell transplantation
Experimental: cell transplantation group
Epidermal Cell transplantation in patients with vitiligo
Intervention: Biological: Melanocyte transplantation
Khodadadi L, Shafieyan S, Sotoudeh M, Dizaj AV, Shahverdi A, Aghdami N, Baharvand H. Intraepidermal injection of dissociated epidermal cell suspension improves vitiligo. Arch Dermatol Res. 2010 Oct;302(8):593-9. doi: 10.1007/s00403-010-1034-7. Epub 2010 Apr 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 75 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
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Royan Institute
Royan Institute
Not Provided
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
Royan Institute
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP