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

NCT ID: NCT01923142

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Outer-Root-Sheath Melanocytes Suspension

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

Group Type: EXPERIMENTAL

Outer-Root-Sheath Melanocytes Suspension

Intervention Type: BIOLOGICAL

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).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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).

Interventions

Outer-Root-Sheath Melanocytes Suspension

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).

Intervention Type: BIOLOGICAL

Placebo

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARIV Onlus

UNKNOWN

Sponsor Role: collaborator

Centro Studi Gised

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Naldi, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Studi Gised

Locations

Papa Giovanni XXIII Hospital

Bergamo, , Italy

Spedali Civili

Brescia, , Italy

Countries

Italy

Other Identifiers

VIT-FOL1

Identifier Type: -

Identifier Source: org_study_id