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Melanocyte Transplantation for Patients With Stable Vitiligo.

Primary Purpose

Stable Vitiligo

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Laser CO2
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Vitiligo focused on measuring Vitiligo, amniotic membrane, malanocytes, C02 laser.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Clinic of Navarre

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo

Secondary Outcome Measures

Full Information

First Posted
October 3, 2012
Last Updated
October 11, 2013
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Spanish Clinical Research Network - SCReN
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1. Study Identification

Unique Protocol Identification Number
NCT01701648
Brief Title
Melanocyte Transplantation for Patients With Stable Vitiligo.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Spanish Clinical Research Network - SCReN

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Vitiligo
Keywords
Vitiligo, amniotic membrane, malanocytes, C02 laser.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Laser CO2
Intervention Description
Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
Primary Outcome Measure Information:
Title
Efficacy of Autologous Melanocyte Transplantion on Amniotic Membrane as a Substrate for Patients With Stable Vitiligo
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University Clinic of Navarre
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25902042
Citation
Redondo P, Gimenez de Azcarate A, Nunez-Cordoba JM, Andreu EJ, Garcia-Guzman M, Aguado L, Prosper F. Efficacy of Autologous Melanocyte Transplantation on Amniotic Membrane in Patients With Stable Leukoderma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):897-9. doi: 10.1001/jamadermatol.2015.0299. No abstract available.
Results Reference
derived

Learn more about this trial

Melanocyte Transplantation for Patients With Stable Vitiligo.

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