Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
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| First Received Date ICMJE | March 3, 2008 | ||||||||||||
| Last Updated Date | June 13, 2011 | ||||||||||||
| Start Date ICMJE | February 2009 | ||||||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
percentage of repigmentation [ Time Frame: 2 and 4 weeks after transplantation ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00631865 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
stability of the achieved repigmentation [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin | ||||||||||||
| Official Title ICMJE | Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin | ||||||||||||
| Brief Summary | The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 3 | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Vitiligo | ||||||||||||
| Intervention ICMJE | Biological: Melanocyte transplantation
Injection of melanocytes directly in Epidermis
Other Names:
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| Study Arm (s) | Experimental: cell transplantation group
Epidermal Cell transplantation in patients with vitiligo
Intervention: Biological: Melanocyte transplantation |
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| Publications * | Khodadadi L, Shafieyan S, Sotoudeh M, Dizaj AV, Shahverdi A, Aghdami N, Baharvand H. Intraepidermal injection of dissociated epidermal cell suspension improves vitiligo. Arch Dermatol Res. 2010 Oct;302(8):593-9. Epub 2010 Apr 4. | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 100 | ||||||||||||
| Completion Date | June 2011 | ||||||||||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 12 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00631865 | ||||||||||||
| Other Study ID Numbers ICMJE | Royan-skin-001 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Hamid Gourabi, Chief, Royan Institute | ||||||||||||
| Study Sponsor ICMJE | Royan Institute | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Royan Institute | ||||||||||||
| Verification Date | February 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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