another contender

Don`t know whether I have posted on this company developing a synthetic scaffold from fibrin a blood derivative that would bring it`s own issues not the least cost. Under "current challenges" at the end of the article there are problems with Smartmatrix that are already largely addressed by BTM. Add to that Polynovo are already in the clinic with two trials complete (one awaiting results) and has partnerships/feasability studies for other applications.

CZD/Polynovo seems way ahead with trials starting for Smartmatrix at the end of 2013, makes you wonder why they are bothering.

The article is useful in highlighting the size of the markets being addressed by CZD.

http://www.raft.ac.uk/synethetic-skin-scaffold

A synthetic ‘off-the-shelf’ skin scaffold that encourages rapid in-growth of the dermis is close to clinical trials that should take place before the end of 2013.

RAFT’s Smart Matrix™ skin scaffold has the potential to become the new standard-of-care in the treatment of a variety of full thickness, life-threatening skin and chronic skin wounds.

In the USA, chronic wounds affect around 6.5 million patients and cost over $25 billion annually; in the UK the cost is around £3 billion ($4.65 billion).

But these figures and costs are probably only the tip of the iceberg. A study found in Denmark that nearly 60% of open pressure sores are not reported in medical records. If Denmark is typical, then the true global numbers and costs must be staggering.

The problem is, although the outer layer of the skin (epidermis) can respond to treatment, the tough, thick inner layer of skin (dermis) does not reform during the healing of a full thickness wound. The wound becomes even harder for the body to heal if the person is suffering from a disease like diabetes.

“When a burn or chronic wound such as a leg ulcer severely damages skin, the body can never regenerate full thickness skin,” says Royal Free plastic surgeon Mr Norbert Kang.

If the patient recovers, they are most times left with disfiguring scares which can impede body movement. In addition, in the case of burns, there might not be enough undamaged skin left for grafts or the poor health of the patient might prevent taking skin grafts.

Traditionally, medical intervention involved grafting skin from other parts of the body to treat the burn or wound. However, in the case of burns there might not be enough healthy skin left to provide grafting material or a burn may be so severe that surgeons cannot carry out a conventional skin graft because there is not enough undamaged skin on which to anchor the graft.

“For some patients, conventional grafts also come with the risk of simply creating a new wound site elsewhere on the body which cannot heal completely,” says Norbert. “This is most problematic in elderly patients with pressure sores and people with diabetic or other chronic ulcers.”

The initial motivation at RAFT to pursue the idea of a ‘Smart Matrix’ was hearing from plastic surgeons about the clinical limitations and failures of existing artificial skin products.

However, it was witnessing the reality of what patients needing surgical skin reconstruction undergo, and talking with patients who had survived and endured prolonged suffering from wound infections that made scientists at RAFT appreciate the urgency of this need and it continues to spur the team forward.

In drawing up criteria for what they had in mind, RAFT’s team came up with the following list:

A synthetic material which reliably ‘integrated’ with the body
It would allow for rapid wound closure
It would minimise scar formation
The product could be easily stored and available to surgeons off-the-shelf.
RAFT looked at existing artificial skin products, the use of donor skin and tissue engineering of new skin; although each its own advantages, there are also disadvantages as well.

Donor skin, while providing for good protection, will in all cases be rejected by the body – usually within three weeks. In itself, donor skin does not provide an effective structure for capillary growth.

Also, despite thorough processing procedures and screening measures, there are concerns about the possibility of transmitting diseases such as prion. Cultured epidermal autografts involves a lag time between two to three weeks and existing artificial skin structures are not suitable for infected wounds or are temporary.

At this point, Smart Matrix™ and workbench technology has been turned over to a clinical manufacturer to be produced under strict regulatory controls. Patient trials will then be just around the corner.

This approach has taken a long time to establish, but we hope that patients will benefit in the end, says CEO Leonor Stjepic.

“We need Smart Matrix™ made under a regulatory framework which RAFT does not have – we’re a research laboratory, not a manufacturing plant. Every aspect of the manufacturing process must be scrutinised; it’s very stringent and very expensive to do,” says Leonor.

However, because the plant is licensed to manufacture items in the strictest of conditions, Smart Matrix™ produce there can be supplied for patient trials anywhere. This will greatly simplify the whole process and hopefully get it to patients quicker.

In pre-clinical trials with experimental wounds, Smart Matrix™ has integrated into the wounds exactly as RAFT was hoping it would. This provided our scientists with more evidence of the reliability of Smart Matrix™ being able in a single step restore a full thickness of skin.

After nine long years, it is impossible not to feel a sense of excitement with RAFT’s Smart Matrix™ team.

“Maintaining objectivity is crucial, but as we draw tangibly close to finding out whether translating the Smart Matrix™ idea into reality that will actually help to rebuild lost skin for patients in desperate need, I cannot help but feel excited,” says Leonor.

Current Challenges

The team is confident that Smart Matrix™ will be effective as a core material in healing many types of skin loss injuries. However it expects that in the most challenging cases, in order to achieve a robust clinical reconstruction of the skin, RAFT will need to combine Smart Matrix™ with other “whole treatment packages” specifically designed to address underlying problems.

For example, in wounds effecting large areas of the body, the loss of fluid and vulnerability to infection mean that an additional layer is needed to allow the Smart Matrix™ to function optimally and promote skin regrowth in these difficult cases.

Another challenge is chronic ulcers resulting from venous problems or diabetes. In these cases there is a cycle of infection and inflammation which perpetuates the ulcer. The Smart Matrix™ package for these wounds needs to reduce the impact of these negative factors and stimulate process of rebuilding skin.

An important type of wound arises from pressure ulcers such as bed sores and ulcers arising from prolonged periods in a wheelchair. These ulcers start off small but become hugely problematic when large cavities are formed underneath the surrounding skin. RAFT anticipates that Smart Matrix™ could be very effective, but may need to be enhanced through further modifications, to rapidly recreate deep tissue bulk.