What is ReCell?

A unique device enabling to produce an autologous skin regeneration suspension - in a simple 30 minute procedure

The suspension comprises of the patient’s cells, together with the signalling factors they express for wound healing

In the treatment of Burns, Plastics, Maxillo-Facial & Trauma Procedures

How the technology works The cells harvested from the epidermal dermal junction include:

• Fibroblasts• Melanocytes• Langerhans Cells• Keratinocytes• Important wound healing factors

These cells:• Are not yet terminally differentiated• Are highly proliferative• Migrate evenly across the wound bed

In this technique we use the Wound bed as culture media

The Autologous Cell Suspension

SET UP STAGE

SET UP CARD

SET UP STAGE

SELF TEST AND ENZYME PREPARATION

SET UP STAGE

BUFFER PREPARATION AND DELIVERY SET PREPARATION

STAGE 1: RECELL SKIN PROCESSING

STAGE 1

1. TAKE SKIN SAMPLE Take a thin, split-thickness shave biopsy (0.15-0.2 mm in depth)

Skin Sample Size Treatment Area 1 cm x 1 cm up to 80 cm2

2 cm x 2 cm up to 320 cm2

Site match biopsy

Take two passes . Use second biopsy only

Take biopsy only from neck or head.

Recommended body donor sites: axial, medial thigh, hip

2. HEAT ENZYME

Run test again by pressing (?) When shows, press play button to heat the Enzyme

3. INCUBATE SKIN SAMPLE

When orange light changes to insert skin sample into incubator well for 15 minutes

STAGE 1

4. DRAW UP BUFFER SOLUTION

Using a 5 mL syringe and blunt needle draw up appropriate volume of Buffer Solution from well B

STAGE 1

Treatment Area Buffer Solution Volume

Up to 80 cm2 1.5 mL

80cm2 – 160 cm2 2.5 mL

160 cm2 – 320 cm2 4.5 mL

WOUND BED PREPARATION

Preparing the wound bed

Clean, well vascularised wound bed Careful debridement to viable dermis Pin-point bleeding should be visible

Choice of instruments

Mechanical Burr Lasers; Erbium YAG, CO2, Fractional Skin needling i.e. Medical rollers Hydro surgery - Versajet Surgical debridement – i.e. dermatome, Humby knife

Keep the prepared wound site moist with saline soaked gauze

STAGE 2: RECELL SUSPENSION PREPARATION

5. TEST SCRAPE

Remove skin sample from incubator and place on tray Gently scrape to test if the cells disaggregate, DO NOT complete scraping If cells do not come away – incubate for a further 5-10 minutes and repeat

step

6. DEACTIVATE RECELL ENZYME

Rinse skin sample briefly in well B

STAGE 2

7. SCRAPE CELLS

Place skin sample on the tray dermal side down Using Buffer Solution in the 5 mL syringe, place a few drops onto the skin

sample Scrape thoroughly to disaggregate the cells

STAGE 2

8. RINSE AND ASPIRATE

Add remaining Buffer Solution from the 5 mL syringe onto the tray, using the solution to rinse the scalpel and tray into one corner

Using the 5 mL syringe and blunt needle, aspirate the cell suspension and again rinse the tray into one corner

STAGE 2

STAGE 3: RECELL SUSPENSION DELIVERY

9. FILTER CELLS

Filter cell suspension through well C Remove cell strainerTip: Tap cell strainer over well

10. DRAW UP RECELL SUSPENSION

Use a new sterile 5 mL syringe with blunt needle to draw up ReCell suspension from well C

STAGE 3

11. DRESSINGS

Ensure the dressings are cut and prepared for immediate application once the cell suspension is applied

STAGE 3

12. APPLY RECELL SUSPENSION TO WOUND BED

If spraying, connect spray nozzle to the syringe If dripping, leave blunt needle in place

N.B. Spraying of less that 2 mL suspension is not recommended

Ensure haemostasis is achieved (adrenaline soaked gauze) at recipient site as blood flow will wash away the sprayed on cells

Start applying cells to the most elevated part of the recipient site

STAGE 3

Cell Volume Recommended Application Method

1.5 mL Drip

2.5 mL Spray or Drip

4.5 mL Spray

Post Treatment Guidelines

PATIENT FOLLOW UP

Infection control is key to allow cells to develop well.

Prophylactic antibiotics are recommended for 1 week.

Antiviral should be considered in case of history of herpes.

The use of cytotoxic medications e.g. silver sulfadiazine is contraindicated

During the healing process the wound may be itchy, for this reason anti-histamines are recommended.

No vigorous or strenuous activity should be undertaken during the first week following the procedure.

POST OPERATIVE CARE

Outer dressings should be debulked on Day 2. • Be careful when removing do not dislodge the primary dressing.

Secondary dressing can be changed if soiled.

Primary dressing will eventually peel off and shed once the new epidermis has formed.

Do not removed primary dress before day 5.

Ensure primary dressing removal is atraumatic. • Do not just pull away if it has stuck to the wound.

Never forcibly remove the primary dressing

POST OPERATIVE CARE

If the primary dressing sticks to the wound:

• Trim the edges as the primary dressing loosens

• Soak remaining dressing in aqueous (saline solution) or oil based solution from day 5 to facilitate atraumatic removal

• Cover to protect with a retention dressing (e.g. Hypafix or Mefix)

• Do not remove unless there are clear signs of infection

Never forcibly remove the primary dressing

PATIENT FOLLOW UP

The newly healed skin is fragile and needs protecting.• Protective dressings must be worn on extremity wounds for two weeks

following initial healing

• Leave the wound open if dry but use a protective dressing if there are shear forces (e.g. foot) until the new epithelium looks resistant enough to withstand such forces.

Regular applications of moisturiser should be applied, 2-3 times a day. This should be gently massaged into the newly formed skin.

Avoid direct sun exposure at least 4 weeks following treatment. New skin should have protected sun exposure by either sun cream 30+ or clothes for at least 3 months.

Patient should not use any stimulating products (retinol or glycolics) until the skin has matured.

CLINICAL SUPPORT MATERIAL

Set Up Card Appointment card

Quick Guide

Stickers

After ReCell

Take skin further with ReCell

ReCell can help take skin further in the treatment of burns when used:

In CombinationDeep burns with meshed autograftsLarge TBSA burns where insufficient donor skin exists allowing wider mesh ratio

AlonePartial thickness burns and paediatric scald injuries in particular

At Donor SiteStimulate regeneration of donor skin for re-harvesting

Case Studies

Date 37

MID DERMAL FACIAL FLAME BURN

Day 9 – ReCell application18 weeks post treatmentCourtesy of Isabel Jones, MBBS MD FRCS Plastics C&W Hospital, London

18 weeks post treatment

MIXED DEPTH PAEDIATRIC SCALD

Before treatment

3 weeks post treatment

10 weeks post treatment10 months post treatmentCourtesy of Jeremy M Rawlins FRCS(Plast)

10 months post treatmentBefore treatment

ReCell Benefits: Burns

Date 40

CLINICAL BENEFITS: BURNS• Smaller donor site area

requirement• Maximises the use of available

healthy skin• Immediately available for use at a

single procedure• Donor skin can be meshed wider

to cover a greater area• Donor sites may be treated for re-

harvesting• Viable melanocytes for normal

pigmentation• Less pain management

CLINICAL NEED: BURNS

• Conventional skin grafting is

burdensome to patients, requiring large amounts of painful donor harvesting, and leaving undesirable scaring

• CEA is time consuming, costly, requires multiple surgeries only produces keratinocytes

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