VitiligoPhase 3NCT00631865
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
A Phase 3 study testing Melanocyte transplantation in people with Vitiligo, run by Royan Institute at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Melanocyte transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- Feb 2009to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant patients
- Patients with active disease
- Infection at the recipient site
- Evidence of köebner in the past
- Keloidal tendencies
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Melanocyte transplantation
- Keywords
- melanocytes
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanocyte transplantationBiological
Also called cell therapy, cell transplantation
Injection of melanocytes directly in Epidermis
| Study group | Role | What they receive |
|---|---|---|
| cell transplantation group | Experimental | Epidermal Cell transplantation in patients with vitiligo Receives: Biological: Melanocyte transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of repigmentation
Measured: 2 and 4 weeks after transplantation
Secondary outcomes (1)
stability of the achieved repigmentation
Measured: 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hossein Baharvand, PhD, Principal investigator, Head of Royan stem cell departmentSaeeid Shafieian, MD, Principal investigator, Firoozgar HospitalNasser Aghdami, MD., PhD, Study director, Head of Royan transplantation Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631865
- Sponsor's protocol ID
- Royan-skin-001
- Status last verified
- Feb 2009
- First submitted
- 3 Mar 2008
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1007/s00403-010-1034-7. Epub 2010 Apr 4.
PubMed 20364383
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
- ClinicalTrials.gov ID
- NCT00631865
- Acronym / sponsor ID
- Royan-skin-001
- Conditions
- Vitiligo
- Keywords
- melanocytes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Feb 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell transplantation group | Experimental | Biological: Melanocyte transplantationEpidermal Cell transplantation in patients with vitiligo |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant patients
- Patients with active disease
- Infection at the recipient site
- Evidence of köebner in the past
- Keloidal tendencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanocyte transplantationAlso: cell therapy, cell transplantationInjection of melanocytes directly in Epidermis | Biological | cell transplantation group |
Primary outcome
percentage of repigmentation
Time frame: 2 and 4 weeks after transplantation
1 secondary outcome
stability of the achieved repigmentation
Time frame: 6 months after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 20364383Khodadadi 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossein Baharvand, PhD principal investigator
Head of Royan stem cell department
Saeeid Shafieian, MD principal investigator
Firoozgar Hospital
Nasser Aghdami, MD., PhD study director
Head of Royan transplantation Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melanocyte transplantation in people with Vitiligo, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of repigmentation (time frame: 2 and 4 weeks after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00631865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.