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.
Laser CO2
Pigmentation Disorders+2
+ Skin Diseases
+ Skin and Connective Tissue Diseases
Treatment Study
Summary
Study start date: December 1, 2010
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location