Melanocyte Transplantation for Patients With Stable Vitiligo.

Stable Vitiligo Clinical Trial

Official title:

Phase I-II, Randomized, Intraindividually Placebo Controlled Clinical Trial, to Evaluate the Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701648
• Other study ID #: LEA/VIT
• Secondary ID: 2009-017757-36
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2012
• Last updated: October 11, 2013
• Start date: December 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

Vitiligo is an acquired skin disease that significantly impacts the quality of life of patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but the results are variable.

This single center, single blind clinical trial comparing another treatment and also no treatment was designed to assess the efficacy of autologous monocyte transplantation in monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane and will provide an untreated area as a control.

Description:

Main Objective:

The main objective is to assess the efficacy of autologous transplantation of monocytes in monolayers grown on a biological substrate of amniotic membrane in the treatment of stable vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation obtained will be studied after 3, 6 and 9 months of treatment.

Secondary Objectives:

To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with melanocytes in monolayers.

To assess how rapidly epithelialization occurs and the cosmetic result in the short and long term of the areas treated with each of the techniques.

To assess if de-epidermization with CO2 laser may be by itself a stimulus for the reservoir of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation obtained with this procedure is merely postinflammatory as a result of trauma to the epidermis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria

• Patients must voluntarily provide informed consent before any of the tests included in the trial which do not form part of standard treatment can be performed.

• Mentally stable patients, suffering from piebaldism, vitiligo of metameric distribution, focal or generalized vitiligo which has remained stable for at least one year without de-pigmentation or spontaneous re-pigmentation after standard medical treatment.

• A minimum hypopigmented area to treat of 100 cm2 (at least 30 cm2 for each of the therapeutic options).

• For women of child-bearing age, a negative pregnancy test.

Exclusion criteria:

• Women who are pregnant or breast-feeding.

• Positive results in any of the blood tests given

• Concomitant serious illness.

• Patients who have received any agent currently the focus of research in the 30 days prior to their inclusion.

• Patients currently participating in another clinical trial or receiving any other agent currently the focus of research.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stable Vitiligo
• Vitiligo

Intervention

Other:
• Laser CO2
Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.

Locations

Country	Name	City	State
Spain	University Clinic of Navarre	Pamplona	Navarre

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo		six months	Yes