Melanocyte Transplantation for Patients With Stable Vitiligo.

This study has been completed.
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01701648
First received: October 3, 2012
Last updated: October 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Stable Vitiligo
Other: Laser CO2
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: December 2010
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: Laser CO2
Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701648

Locations
Spain
University Clinic of Navarre
Pamplona, Navarre, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Spanish Clinical Research Network - CAIBER
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01701648     History of Changes
Other Study ID Numbers: LEA/VIT, 2009-017757-36
Study First Received: October 3, 2012
Last Updated: October 11, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Vitiligo, amniotic membrane, malanocytes, C02 laser.

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014