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

Study Overview
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Brief Summary
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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.

Official Title
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Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Biological: Outer-Root-Sheath Melanocytes Suspension
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outer-Root-Sheath Melanocytes Suspension<br>This arm includes all patients sides (left or right) treated with autologous outer-root-sheath melanocytes suspension followed by targeted UVB phototherapy | Biological: Outer-Root-Sheath Melanocytes Suspension<br>* The treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).<br>|
| Placebo Comparator: Placebo<br>This arm includes all patients sides (left or right) treated with placebo followed by targeted UVB phototherapy | Biological: Placebo<br>* The treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale |  | 6 weeks, 12 weeks | 
| Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale |  | 6 weeks, 12 weeks | 
| Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale |  | 6 weeks, 12 weeks | 
| Any repigmentation of the treated areas from baseline as assessed by image analysis |  | 6 weeks, 12 weeks | 
| Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect) |  | 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitiligo, Outer-Root-Sheath, Melanocytes, Hair Follicles