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ICX-SKN - Skin graft replacement for burns and acute wounds

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Play to view the ICX-SKN animation View the ICX-SKN animation



(first photo) scientist putting cell media into trays in which ICX-SKN is grown. (second photo) piece of ICX-SKN about 2cm by 3cm in size. third photo) ICX-SKN being used in clinical setting

ICX-SKN comprises allogeneic  human dermal fibroblasts set in a natural human collagen matrix, which mimics the structure of skin and is intended as a skin graft replacement. An additional layer of human keratinocytes may be included to form an epidermal layer.

ICX-SKN is designed to be sufficiently durable to integrate and persist in burns and acute wounds providing immediate and long-term closure. It is intended that ICX-SKN will be used by surgeons, plastic surgeons and other specialists in hospitals and clinics in place of a skin graft, for example, in skin cancer excisions such as basal cell carcinomas and squamous cell carcinomas. ICX-SKN will be provided in a sealed sterile, flat, foil pack

 

Background and market opportunity

 

Burns: Intercytex is the only non-US member of a group that has been selected to establish the US Armed Forces Institute of Regenerative Medicine (AFIRM), supported by a foundation grant from the US Government totalling $85 million.  The purpose of AFIRM is to use the science of regenerative medicine to develop new treatments for battlefield injuries.  Under this programme, ICX-SKN will be developed for the treatment of battlefield burns in collaboration with the US army, with US government funding.  Following a successful development programme, Intercytex would supply the US armed forces with ICX-SKN, and the product would also be available for use in civilian burns patients, of which it is estimated that there are around 80,000 cases requiring hospitalisation in the US each year.

 

scientist adding cell media to trays in which ICX-SKN is grown

Acute wounds: An excision is currently treated in different ways.  If possible, the sides of the wound are pulled together and are stitched or sutured (primary closure).  This can cause tension in the surrounding skin and an unsatisfactory outcome.  In these cases, a flap of skin is carefully cut from an adjacent area of skin, keeping the blood supply intact and rotated to cover the excised wound.  Other excisions are left to heal from within (secondary intention) without any graft or closure or are treated with a skin graft cut from an entirely different area of the body.  Wound healing and scarring are dependent on movement and tension and the ability of layers of skin to be reperfused with a new blood supply. 

 

With a skin cancer excision there is a compromise between taking the minimum amount of tissue to enable the wound to close with a satisafactory functional and cosmetic outcome versus the removal of sufficient tissue to ensure a safe margin around the tumour.  In some instances, excisions could be more radical if graft skin was available, therefore improving the outcome.

 

ICX-SKN is designed to heal wounds with reduced scarring and an enhanced aesthetic effect, a significant factor given that most skin cancers are on the face and hands. Intercytex estimates there is a global market of $2 billion based on one million excisions carried out each year worldwide. *

 

ICX-SKN clinical and commercial development

 

ICX-SKN has completed an open-label Phase I trial in the UK designed to evaluate the safety, tolerability, graft integration and persistence of ICX-SKN.  A full-thickness skin sample was excised from the upper arm of 12 subjects and replaced with ICX-SKN.  Six subjects were followed for one month, four for three months and two for six months.   All grafts were totally excised at the end of the follow-up period and examined histologically. In all subjects, ICX-SKN was very well tolerated with no serious events reported.  There was no evidence of graft rejection; both visual and histological analysis showed that in all volunteers, skin grafts were vascularised rapidly and overgrown with the hosts own cells, resulting in a fully integrated skin graft that had closed and healed the wound site.

 

To download a copy of the poster that was exhibited at the 17th Annual meeting of the European Tissue repair Society, please click on the link below:


A Phase I study of ICX-SKN, an allogeneic living skin replacement

 

a larger piece of ICX-SKN, about 10cm by 10cm in size, to be used in research and clinical trialsA Phase IIa efficacy trial in trauma and burns patients at US military hospitals will start during 2009.

 

The development of ICX-SKN in burns, through all stages of clinical development and registration to launch will be funded by AFIRM.  Intercytex will conduct proof-of-principle studies in excisions itself and will then seek a partner to assist in later stage trials and sales and distribution.   A succesful burns programme would allow Intercytex to commence an accelerated development programme for use of ICX-SKN in surgical incisions.

 

Manufacturing

 

Intercytex will manufacture ICX-SKN at its GMP compliant manufacturing facilities.

 

*Source: Collins Therapeutic Consulting

 

Glossary

 
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