Project: Novel absorbable collagen membrane for guided tissue regeneration and adhesion prevention following surgical intervention

BACKGROUND_x000D_Muscles, bones, nerves, blood vessels, and connective tissues are intimately involved structures within the body. When any area of the body undergoes a surgical procedure, part of the surgeon’s challenge is to repair the structures in need, without traumatizing nearby tissues. Unfortunately, post-surgical adhesions and scars are a natural and necessary part of the recovery process, as tissues heal after surgery._x000D__x000D_Adhesions form as the first step in the healing process. Tiny crosslinks (the ‘building blocks’ of adhesions) rush in to begin the repair process. These microscopic but strong fibres begin the process of post-surgical adhesion formation, creating scars that last a lifetime._x000D__x000D_Crosslinks, adhesions, and scars all describe the same product of healing – a glue-like substance that forms in three areas:_x000D_ 1. in tissues the surgeon cut to access the surgical site_x000D_ 2. where the surgeon cut, burned, or sutured tissues that required surgical intervention, and_x000D_ 3. in nearby tissues that were inflamed by the surgery, or by adhesive pulls after the surgery._x000D__x000D_CLINICAL NEED_x000D_Approximately 70 million surgical procedure-based wounds are created globally each year. Adhesions are a major source of patient morbidity and healthcare costs and in Europe cost around €1 billion in hospitalizations and inpatient care. Post-surgical adhesions and scars can connect tissues creating pain and in some cases, inhibiting normal bodily functions. _x000D__x000D_Until recently, lysis of adhesions was the only choice medical science offered to treat adhesions. This involves cutting or burning the adhesions under general anesthesia, via laparoscopy or laparotomy (open surgery). While lysis of adhesions can be effective, surgery has two major drawbacks in that it carries risks from anesthesia and infection, and despite the best skills of the finest surgeon, the body creates more adhesions as it heals from the surgery designed to remove them._x000D__x000D_This last concern was highlighted in a large study (Ellis et al 1999 Lancet: Br J Med 353:1476-80) that reported 35% of all open abdominal or pelvic surgery patients were re-admitted to the hospital more than twice to treat post-surgical adhesions, during the 10 years after their original surgery. Many follow-up surgeries (22%) occurred in the first year after surgery, and “readmissions continued steadily throughout the 10-year period” of the study._x000D__x000D_For even the most skilled surgeon, surgery is a primary cause of adhesions. Another study (Liakakos et al 2001 Dig Surg 18:260-273) showed that more than 90% of patients develop adhesions following open abdominal surgery and 55% to 100% of women develop adhesions following pelvic surgery. Small-bowel obstruction, infertility, chronic abdominal and pelvic pain, and difficult re operative surgery are the most common consequences of peritoneal adhesions. Despite elaborate efforts to develop effective strategies to reduce or prevent adhesions, their formation reCOs a frequent occurrence after abdominal surgery. Thus, many patients become trapped in a cycle of surgery-adhesions-surgery._x000D__x000D_Post surgical adhesions are also an issue in cardiac and spinal surgery. In the case of cardiac adhesions, lesions involving the right ventricle can lead to death. Any re-intervention is often complicated by adhesions. For example, in spine surgery, disc hernias can be recurrent, re-interventions are frequently complicated by dura mater adhesions that require fine dissection and increase surgical time and costs. _x000D__x000D_PROJECT APPLICATIONS AND OBJECTIVES_x000D_We have developed a proprietary collagen-based sheet that can be utilised during surgery to prevent adhesions from forming. The material is highly versatile and can be used as a sheet or wrap for a range of surgical procedures. Furthermore, the material can be designed to provide guides for cell growth such as the renervation of particular tissues following surgery. The material has performed exceptionally well during our preclinical investigations and we are now ready to commence the scale-up production and clinical assessment of the product for different surgical indications. _x000D__x000D_The Eurostars project has been designed to continue the development of this product through cGMP manufacture and assessment in 4 different clinical applications. This project will further the development and knowledge of the collagen membrane. On completion we will be in a strong position to commercialise and we will seek regulatory approval for marketing of the product._x000D_ _x000D_PROJECT CONSORTIUM_x000D_The consortium consists of Biom'Up, a French SME, we will conduct the scale up and cGMP manufacture of the collagen membranes. Clinical assessment of the performance of the collagen membranes will be assessed by our clinical P the Charité in Germany._x000D_

Acronym COLLAD (Reference Number: 5923)
Duration 01/03/2011 - 30/06/2013
Project Topic Development of adhesions following surgery can cause significant health problems and in many cases require additional surgery. We have developed a proprietary collagen-based material that can prevent adhesions forming and provide guides for normal tissue development.
Project Results
(after finalisation)
According to the consortium agreement and the project application, Biom’up works with an institution: The Charité (Berlin, Germany). The two Ps collaborate and work on the progress of all deliverables. Regulary, call conferences are performed, emails are exchanged and meetings are organized to discuss on the progress of the clinical studies._x000D__x000D_The WP N°1 and N°2 are achieved. _x000D_The WP N°3, WP N°4, WP N°5, WP N°6 and N°7 are also completed. _x000D_Regarding the WP N°3, all the inclusions are done. The collection of data is completed as well as the statistical analysis and the writing of the report._x000D_Regarding the WP N°4, 40 patients have been included. 14 reinterventions were performed. The statistical analysis and the writing of the report are performed._x000D_Regarding the WP N°5, the clinical trial is over with the 30 included patients. The collection of data is completed as well as the statistical analysis and the writing of the report. _x000D_Regarding the WP N°6, all the inclusions are done. The collection of data is completed as well as the statistical analysis and the writing of the report._x000D_Thus, regarding the WP N°7, projects and scientific meetings were regularly organized between Ps to assess the progress of the project. These meetings were generally performed by call conference but at least one face to face meeting was organized by year. E-mails were also exchange in order to follow the projects more actively.
Network Eurostars
Call Eurostars Cut-Off 5

Project partner

Number Name Role Country
2 Biom'Up Coordinator France
2 Charité – Campus Virchow, Research Building (Forschungshaus) Partner Germany