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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01923142
• Other study ID #: VIT-FOL1
• Status: Terminated
• Phase: Phase 2
• First received: August 9, 2013
• Last updated: January 26, 2016
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Centro Studi Gised
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Biological:
• 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).
• 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).

Locations

Country	Name	City	State
Italy	Papa Giovanni XXIII Hospital	Bergamo
Italy	Spedali Civili	Brescia

Sponsors (2)

Lead Sponsor	Collaborator
Centro Studi Gised	ARIV Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis		12 weeks	No
Secondary	Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale		6 weeks, 12 weeks	No
Secondary	Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale		6 weeks, 12 weeks	No
Secondary	Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale		6 weeks, 12 weeks	No
Secondary	Any repigmentation of the treated areas from baseline as assessed by image analysis		6 weeks, 12 weeks	No
Secondary	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	No