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Trial registered on ANZCTR


Registration number
ACTRN12607000635460
Ethics application status
Approved
Date submitted
7/12/2007
Date registered
12/12/2007
Date last updated
12/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE USE OF MELANOCYTE/KERATINOCYTE CO-SUSPENSION FOR THE RE-PIGMENTATION OF AMELANOTIC PATCHES IN VITILIGO
Scientific title
THE USE OF MELANOCYTE/KERATINOCYTE CO-SUSPENSION FOR THE RE-PIGMENTATION OF AMELANOTIC PATCHES IN VITILIGO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitiligo 2609 0
Condition category
Condition code
Skin 2727 2727 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Keratinocyte/melanocyte co-suspension preparation
‘CellStat’ is a one-step keratinocyte/melanocyte isolation process, which is performed under aseptic conditions in the operating theatre. The skin biopsy is taken from the patient, processed and the keratinocyte/melanocyte co-suspension generated is sprayed back onto the site requiring coverage. This process is entirely autologous and uses medium supplemented with patient’s serum prepared on the day.

SPECIMEN REQUIREMENTS
The skin biopsy is to be taken from an area of normo-pigmented skin adjacent to, but not within 2cm of, the leukodermic patch to enable the closest colour-matched start point (See D, Figure 1). The donor area will be subcutaneously infiltrated with 0.25% bupivacaine with 1:400,000 adrenaline and the biopsy taken using the Zimmer electric dermatome with 1 inch plate and set at 7/1000ths of an inch thick. The donor area will be dressed with a thin hydrocolloid dressing (DuodermTM Thin, 3M Healthcare, St Paul, Minnesota, USA). Four tubes of blood will be taken from the patient before the procedure begins from which serum will be prepared. The blood samples will be centrifuged at 3000rpm for 15 minutes to separate the serum from the cellular components. The autologous serum (AS) is pooled into a sterile 50ml tube using a transfer pipette. Ten millilitres of this serum is added to a bottle of sterile Dulbecco’s Modified Eagle’s Medium (DMEM) to make the DMEM-2%AS required for re-suspension of cells.
The skin biopsy will be rinsed thoroughly in phosphate buffered saline (PBS) before being cut into small, narrow strips (~0.5cm x 2cm). These skin pieces will then be transferred into a petri dish containing warm Dispase II solution (Gibco Invitrogen; 4mg/ml in PBS) and incubated for 15-20 minutes on a heating block set at 37oC. Dispase cleaves the adhesion molecules at the dermo-epidermal junction allowing separation of the epidermal sheets from the dermal tissue. At the end of the Dispase II treatment, the epidermal sheets can be gently peeled from the dermal tissue and kept transiently in a PBS containing dish until all the epidermal sheets have been obtained. The sheets are then transferred into a 70ml container containing a magnetic stirrer and 20mls of 0.05% trypsin-0.53mM EDTA (Gibco Invitrogen) and trypsinised for 5 minutes on the magnetic plate set at 700rpm. This level of agitation and length of trypsinisation allows for the isolation of the majority of the keratinocytes and melanocytes from the basal epidermal layer without isolating a large number of the differentiated suprabasal cells. The trypsin is quenched with 20mls of soybean trypsin inhibitor (Sigma; 0.1mg/ml in DMEM). The resultant cell suspension is passed through a 70mm cell to remove the undigested cornified sheets and large cell clumps and centrifuged at 1200rpm. The cells are re-suspended in the required volume of media for administration.

SURGICAL PROCEDURE
The site to receive the cell suspension (A or B) is randomised by sealed envelopes produced before the commencement of the study. The randomisation will be double-blinded to surgeon and patient, known only to the technicians preparing the treatment samples.
Three areas within the study patch will be delineated by ink lines. Each area will be 1cm x 1cm in area and separated from each other by at least 2 cm. Two of the areas will be wholly within the study patch and not encroaching at any point on the normo-pigmented skin at the patch edge. The third area will cross the edge of the patch onto normo-pigmented skin at one of its faces.


The treatment will be organised as follows:
The three treatment areas will be subcutaneously infiltrated with 0.25% bupivacaine with 1:400,000 adrenaline; for local anaesthesia, patient comfort post-operatively and to ensure a bloodless bed for study dressing application. Patches A and B – these will be sited entirely within the leukodermic area. Both will be dermabraded using a diamond-tipped burr. Both patches will be ‘treated’; one with medium PLUS keratinocyte/melanocyte cell suspension, the other with medium alone. Which patch receives the suspension will be randomised and double-blinded. Post-dermabrasion, the test areas will be covered with individual adhesive, occlusive, transparent film dressings (TegadermTM, 3M Healthcare, St Paul, Minnesota, USA). A sterile 25G (orange-hubbed) needle will be used to puncture the film over the dermabraded area and the treatment fluid will be injected until the dermabraded area is completely covered. Area C will be located so that the dermabraded area overlaps the edge of the patch onto normo-pigmented skin and will be treated by dermabrasion alone and similarly covered with TegadermTM. A gentle compression dressing will be applied over the whole treatment area to prevent reactive haemorrhage at the treatment sites and consequent haematoma formation under the occlusive dressings.
Intervention code [1] 2348 0
Treatment: Other
Comparator / control treatment
Dermabrasion without cell suspension - this process performed at the same surgical episode as the treatment application and assessed at the same time-points with the same outcome measures. It is a 'one off' process. The duration of the control is until the end of the trial period.
Control group
Active

Outcomes
Primary outcome [1] 3620 0
Repigmentation-
The Visual Pigmentation Scoring Scale (VPSS) will be used to assess re-pigmentation See below for description of scoring scale.

KP-No pigmentation (previously pigmented area)
0-No pigmentation (vitiligo area)
1-Minimal pigmentation
2-Slight pigmentation
3-Normal pigmentation
4-Slight hyperpigmentation
5-Marked hyperpigmentation
KP=Koebner?s Phenomenon.

Measurement of colour change will also be performed using a miniature fibre-optic spectrometer (StellarNet Inc., Oldsmar, 34677, USA), and supporting digital photographs will be taken at each time point using a Sony 5.2 megapixel camera with macro lens.
Timepoint [1] 3620 0
3,6,9,12,24,36,52 weeks
Secondary outcome [1] 6061 0
RATE OF REEPITHELIALISATION by direct clinical visualisation supprted by colour digital photography.
Timepoint [1] 6061 0
Daily (from day 3) until epithelialised

Eligibility
Key inclusion criteria
Patients must have established vitiligo of any duration (an idea of the efficacy of the treatment in early, active vitiligo must be gained).
Patients must be > 18 years old
Patients must be able and willing to provide consent to all aspects of the study following verbal and written explanation of the study by the investigating clinician.
Patients must have a leukodermic patch for study, which is outside cosmetically sensitive areas such as the face ie low back, medial thigh, medial arm etc.
Patients must have no documented previous reaction to local anaesthetic agents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any contraindication to surgery/anaesthesia
Any failure of consent process

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient met inclusion criteria
Patient provided with verbal and written information about study process and aims
Patient signed informed consent
Treatment allocated by random envelope allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment site (receiving cells) and control site (receiving placebo) allocated by random envelope allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 513 0
5000

Funding & Sponsors
Funding source category [1] 2868 0
Hospital
Name [1] 2868 0
Royal Adelaide Hospital
Country [1] 2868 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 2585 0
None
Name [1] 2585 0
Address [1] 2585 0
Country [1] 2585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4807 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 4807 0
Ethics committee country [1] 4807 0
Australia
Date submitted for ethics approval [1] 4807 0
01/09/2004
Approval date [1] 4807 0
20/10/2004
Ethics approval number [1] 4807 0
060107

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28232 0
Address 28232 0
Country 28232 0
Phone 28232 0
Fax 28232 0
Email 28232 0
Contact person for public queries
Name 11389 0
John Greenwood
Address 11389 0
Burns Unit, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 11389 0
Australia
Phone 11389 0
0422 000809
Fax 11389 0
(08) 8222 5676
Email 11389 0
john.greenwood@health.sa.gov.au
Contact person for scientific queries
Name 2317 0
Bronwyn Dearman
Address 2317 0
Skin Engineering Laboratory, Institute of Medical and Veterinary Science, Frome Road, Adelaide, SA 5000
Country 2317 0
Australia
Phone 2317 0
(08) 8222 3132
Fax 2317 0
Email 2317 0
bronwyn.dearman@imvs.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInterventions for vitiligo.2015https://dx.doi.org/10.1002/14651858.CD003263.pub5
N.B. These documents automatically identified may not have been verified by the study sponsor.