Project: Drug-eluting anti-adhesion implant with new physical barrier functionality and capability to locally deliver active agents
Adhesions are fibrous bands of scar tissue that abnormally link internal organs and tissues and develop 8 to 15 days after surgery, infection, or trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis or chest. _x000D_In most cases the adhesions do not endanger a patient’s life but in some 5% of cases they can and do lead to serious adhesion-related disorders including:_x000D_- cardiac adhesions, responsible for 15%-20% of the 350 000 open heart surgeries performed annually in Europe and the 450 000 in the USA (FDA, 2010), may restrict heart activity and complicate any additional surgical procedures_x000D_- post- intra-abdominal surgical adhesions occur in 60–95% of patients after laparoscopic surgery (ESGE, 2010) and are the primary cause of intestinal obstructions - 30–41% of all cases requiring further surgery and the cause of 20% of cases of infertility in women (AJOG, 2010). _x000D__x000D_Currently, the CO approaches used to minimize the effects of adhesions – apart from good surgical technique - are the local administration of pharmacological agents or the use of mechanical barriers. _x000D__x000D_Several pharmacological agents have been evaluated for their efficacy to prevent post-surgical fibrous adhesion formation:_x000D_- Anti-inflammatory agents such as non-steroidal anti-inflammatory drugs (NSAID), with corticosteroids expected to reduce any inflammatory response_x000D_- Other agents tested include fibrinolytic agents, anticoagulants and antibiotics_x000D_- Anti-septic drugs prevent microbial infection and increase the healing process on the wound but do not prevent adhesion formation effectively because of their rapid clearance from the affected site._x000D__x000D_Other attempts to reduce adhesion formation include the use of physical anti-adhesion barriers, which are bioresorbable surgical implants comprised of instilled solutions or locally applied physical barriers placed around an organ to protect it from the surrounding tissue. Various materials (PEG, polysaccharides, PLA, PGA, PLGA, collagen, fibrin) have been evaluated for their potential efficacy to prevent adhesion formation, and products brought to market (Seprafilm®, Interceed®, Adept®). However, no single existing barrier has proven to be clearly effective since it:_x000D_- often proves to be difficult to handle during surgery and _x000D_- interferes with blood supply or produces foreign bodies during the elimination process which may lead to major inflammatory reactions which, in turn, may even exacerbate tissue adhesion. _x000D__x000D_To overcome these limitations, two synergistic Ps, GROUPE BRUNO MATIN DG (BMATIN) and INNOCORE PHARMACEUTICALS (INNO) have decided to launch the ACTIVE BARRIER project which aims to develop a new drug-eluting anti-adhesive barrier with improved physical barrier functionality and the capability to locally deliver pharmacologically active agents to effectively prevent post-surgical fibrous tissue formation. _x000D__x000D_BMATIN (Project leader) is a French R&D SME that develops and manufactures biomedical devices for intra-abdominal surgery. INNO is a Dutch R&D biopharmaceutical drug delivery SME which is an expert in developing injectable and implantable biodegradable drug delivery products and combination products composed of novel biodegradable polymers._x000D__x000D_The new drug-eluting anti-adhesion barrier will be easily applicable on adhesiogenic organs and non-reactive so as to effectively protect high-risk tissue during the natural wound healing process before being naturally resorbed and completely cleared from the body. The additional capability to release active compounds (e.g. anti-inflammatory and antiseptic) is expected to significantly improve the clinical performance of the device. _x000D__x000D_The ACTIVE BARRIER project will use a novel class of hydrophilic biodegradable phase-separated multi-block copolymers to develop drug-eluting anti-adhesive sheets with the following characteristics:_x000D_- Improved self-adaptability due to better mechanical and thermal characteristics_x000D_- Improved tissue interaction and reduced foreign body response due to the optimized hydrophilic nature and sound wetting characteristics of the polymers _x000D_- Predictable bioresorption rate and complete elimination of the sheets from the body process within 2-4 weeks_x000D_- Controlled delivery of anti-inflammatory and/or antiseptic active compounds during the first 7 to 14 days after implantation of the ACTIVE BARRIER sheet._x000D__x000D_This is a most innovate approach compared to the current products and therapies since easy-handling and clinically effective anti-adhesive sheets with drug-eluting capabilities are simply not present on the market today. _x000D_The implant, through the local delivery of anti-inflammatory and/or antiseptic active compounds will actively interfere in the biological process of fibrous tissue formation, which is expected to result in a major improvement of the therapy and will lead to improved clinical results and allow patients to fully enter a therapeutic phase at an earlier stage. _x000D__x000D_
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Acronym
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ACTIVE BARRIER
(Reference Number: 7312)
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Duration
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01/12/2012 - 01/12/2015
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Project Topic
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Development of a new drug-eluting anti-adhesive barrier with improved physical barrier functionality and the capability to locally deliver pharmacologically active agents to effectively prevent post-surgical fibrous tissue formation
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Network
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Eurostars
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Call
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Eurostars Cut-Off 8
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Project partner
