Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00631865|
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : July 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Biological: Melanocyte transplantation||Phase 3|
Vitiligo is a pigmentation disorder in which white patches of skin appear on different parts of the body. Histologically it is characterized by absence of melanocytes along the epidermal basal layer.
Using cell suspension with non-cultured melanocytes which injected into blister of depigmented lesion, a success rate of 85% was reported for repigmentation. However there are some limitations in this technique: the induction of blister is limited to several sites of the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral melanocytes and leakage of suspension out of the blister. To reduce these problems, in this study we will inject melanocytes directly to epidermis.
A shaved biopsy specimen (about 1 cm2) is taken from the patient's normally pigmented area under local anesthesia (lidocaine hydrochloride 20 mg/ml). The specimens are incubated in 0.25% trypsin solution for 15 minutes at 37°C 0.02% EDTA solution for 10 minutes. Then epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37C for 3-5 minutes. Well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||May 2015|
Experimental: cell transplantation group
Epidermal Cell transplantation in patients with vitiligo
Biological: Melanocyte transplantation
Injection of melanocytes directly in Epidermis
- percentage of repigmentation [ Time Frame: 2 and 4 weeks after transplantation ]
- stability of the achieved repigmentation [ Time Frame: 6 months after transplantation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631865
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 1665659911|
|Principal Investigator:||Hossein Baharvand, PhD||Head of Royan stem cell department|
|Principal Investigator:||Saeeid Shafieian, MD||Firoozgar Hospital|
|Study Director:||Nasser Aghdami, MD., PhD||Head of Royan transplantation Lab|