Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Melanocyte transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring melanocytes
Eligibility Criteria
Inclusion Criteria:
- Age over 12 years
- Stable form of vitiligo (no increase in the size of the lesion for at least one year)
- No use of immunosuppressive & cytotoxic drugs at least for past 6 months
Exclusion Criteria:
- Pregnant patients
- Patients with active disease
- Infection at the recipient site
- Evidence of köebner in the past
- Keloidal tendencies
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cell transplantation group
Arm Description
Epidermal Cell transplantation in patients with vitiligo
Outcomes
Primary Outcome Measures
percentage of repigmentation
Secondary Outcome Measures
stability of the achieved repigmentation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631865
Brief Title
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Official Title
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
melanocytes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cell transplantation group
Arm Type
Experimental
Arm Description
Epidermal Cell transplantation in patients with vitiligo
Intervention Type
Biological
Intervention Name(s)
Melanocyte transplantation
Other Intervention Name(s)
cell therapy, cell transplantation
Intervention Description
Injection of melanocytes directly in Epidermis
Primary Outcome Measure Information:
Title
percentage of repigmentation
Time Frame
2 and 4 weeks after transplantation
Secondary Outcome Measure Information:
Title
stability of the achieved repigmentation
Time Frame
6 months after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 12 years
Stable form of vitiligo (no increase in the size of the lesion for at least one year)
No use of immunosuppressive & cytotoxic drugs at least for past 6 months
Exclusion Criteria:
Pregnant patients
Patients with active disease
Infection at the recipient site
Evidence of köebner in the past
Keloidal tendencies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossein Baharvand, PhD
Organizational Affiliation
Head of Royan stem cell department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saeeid Shafieian, MD
Organizational Affiliation
Firoozgar Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD., PhD
Organizational Affiliation
Head of Royan transplantation Lab
Official's Role
Study Director
Facility Information:
Facility Name
Royan Institute
City
Tehran
ZIP/Postal Code
1665659911
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20364383
Citation
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. doi: 10.1007/s00403-010-1034-7. Epub 2010 Apr 4.
Results Reference
derived
Links:
URL
http://www.royaninstitute.org
Description
Related Info
Learn more about this trial
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
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