Melanocyte Transplantation for Patients With Stable Vitiligo.

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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01701648

Enrollment

Registered

2012-10-05

Start date

2010-12-31

Completion date

2013-06-30

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Vitiligo

Keywords

Vitiligo, amniotic membrane, malanocytes, C02 laser.

Brief 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.

Detailed 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.

Interventions

OTHERLaser CO2

Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo	six months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026