Melanocyte Transplantation for Patients With Stable Vitiligo.
NCT ID: NCT01701648
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2010-12-31
2013-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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1
Laser CO2
Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
Interventions
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Laser CO2
Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Spanish Clinical Research Network - SCReN
NETWORK
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Locations
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University Clinic of Navarre
Pamplona, Navarre, Spain
Countries
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References
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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.
Other Identifiers
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2009-017757-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LEA/VIT
Identifier Type: -
Identifier Source: org_study_id