Clinical trial NCT00631865: Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Official title: Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitiligo
Keywords: melanocytes
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2008-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: percentage of repigmentation
timeFrame: 2 and 4 weeks after transplantation
Secondary outcomes:
measure: stability of the achieved repigmentation
timeFrame: 6 months after transplantation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan stem cell department
name: Hossein Baharvand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Firoozgar Hospital
name: Saeeid Shafieian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Royan transplantation Lab
name: Nasser Aghdami, MD., PhD
role: STUDY_DIRECTOR
References:
citation: 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.