Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT00631865
First received: March 3, 2008
Last updated: June 13, 2011
Last verified: February 2009

March 3, 2008
June 13, 2011
February 2009
April 2011   (final data collection date for primary outcome measure)
percentage of repigmentation [ Time Frame: 2 and 4 weeks after transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00631865 on ClinicalTrials.gov Archive Site
stability of the achieved repigmentation [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vitiligo
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2011
April 2011   (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
Both
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00631865
Royan-skin-001
Yes
Hamid Gourabi, Chief, 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