Efficacy of Autologous Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

Centro Studi Gised

Status and phase: Terminated; Phase 2

Conditions: Vitiligo

Treatments: Biological: Outer-Root-Sheath Melanocytes Suspension; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01923142

VIT-FOL1

Details and patient eligibility

About

The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.

Enrollment: 4 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of symmetric lesions of vitiligo at the back of the hands with an extension >5cm²
• Vitiligo lasting at least one year at the backs of both hands
• Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
• Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
• Suspension of topical medications for at least 15 days prior to the enrollment date

Exclusion criteria

• Presence of active vitiligo or Koebner phenomenon
• Difference of more than 10% in the extension of symmetrical areas of vitiligo
• Presence of systemic infections or infections localized to the tissues intended for transplantation
• History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
• Presence or history of malignancy
• Chemotherapy or radiation therapy in progress
• History of allergies or adverse reactions to local anesthetics
• Presence of transmissible diseases (human immunodeficiency virus, hepatitis B and C, human T-lymphotropic virus type I and II, syphilis, cytomegalovirus, Creutzfeldt-Jacob, tuberculosis)
• Women who are pregnant or intend to become pregnant during the study period (including breastfeeding women)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

Outer-Root-Sheath Melanocytes Suspension

Experimental group

Description:

This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy

Treatment:

Biological: Outer-Root-Sheath Melanocytes Suspension

Placebo

Placebo Comparator group

Description:

This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy

Treatment:

Biological: Placebo