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Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00631865
Enrollment
300
Registered
2008-03-10
Start date
2009-02-28
Completion date
2015-05-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Keywords

melanocytes

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.

Interventions

BIOLOGICALMelanocyte transplantation

Injection of melanocytes directly in Epidermis

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
percentage of repigmentation2 and 4 weeks after transplantation

Secondary

MeasureTime frame
stability of the achieved repigmentation6 months after transplantation

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026