There is a lot of global interest in Advanced Therapy Medicinal Products (ATMP). These products involve regenerative medicine, such as therapies targeting cells, genes, and tissues, all of which build or replace organs in the body. For many years, RISE has collaborated with biotech company VERIGRAFT on a new method for personalised blood vessels for the transplantation of veins with valves.
Millions of people worldwide suffer from chronic venous insufficiency, a condition that occurs when the function of one or more of the deep veins containing valves has diminished. There is no effective treatment for the condition at present. When the valves are unable to close tightly, leg swelling and slow-healing wounds may occur due to blood not being pumped adequately from the legs back to the heart. With the new treatment, personalised vessels and valves can be transplanted without immunologic transplant rejection. Organ transplantation is never a simple matter and a patient needs to take immunosuppressants for the rest of their life to prevent their body from rejecting the organ. RISE has assisted VERIGRAFT in developing personalised tissue engineered veins (P-TEV) with a method that prevents a patient’s body from rejecting the transplanted organ.
– “The entire industry wants to move towards personalising organs prior to transplantation,” says Joakim Håkansson, researcher at RISE. “We have started using a new method where we decellularise the organ, which involves scrubbing away all the cells so that only the extracellular matrix of connective tissue remains. The extracellular matrix is then reconditioned with the patient’s own blood and prepared for recellularisation when the organ is transplanted into the body.”
VERIGRAFT and RISE work together on both venous and arterial valves, but have made the most progress in studies on veins and the tests have been successful. Preparations are being made for clinical patient trials in Spain. The trials we supposed to commence before the summer of 2020, but have been delayed owing to the coronavirus pandemic and will resume shortly.
The method can also be used in other areas. For example, in coronary artery surgery, and for kidney disease where repeated dialysis can damage a patient’s blood vessels to such as degree that the vessels need to be replaced by an arterial venous shunt.
– “Despite the considerable focus on ATMP, there is a lack of adequate structures in Sweden,” says Håkansson. “Nor is there a vast range of production facilities. VERIGRAFT is one of the most advanced companies in the world with its product.”
The good collaborative climate and high level of expertise possessed by RISE’s employees have been fundamental
From idea to finished product
That RISE has assisted in VERIGRAFT’s product development bodes well for a good, long-term working relationship. The collaboration with VERIGRAFT is a good example where RISE has been involved throughout the development stage, and the project constitutes a contract project in which public funding has been applied for and obtained through joint research proposals.
– “Since 2014, VERIGRAFT has worked with RISE and the organisation’s experts on a series of projects,” says Petter Björquist, CEO of VERIGRAFT. “RISE has played a particularly important role in VERIGRAFT’s flagship project P-TEV, which aims to test, for the first time, the company’s personalised veins with valves. RISE researchers and project managers have provided VERIGRAFT with essential expertise. Examples of things RISE has contributed include functional evaluation models, quality testing, sterilisation methods, manufacturing process automation and regulatory documentation. RISE has filled gaps in VERIGRAFT’s own expertise, which would have been very difficult to acquire in other ways. The good collaborative climate and high level of expertise possessed by RISE’s employees have been fundamental to VERIGRAFT’s development.”
– “RISE listens to the industry and its starting point is always the needs of customers. We are happy to serve in a partner role and we are involved all the way from idea to finished product. There are numerous RISE employees working in the area with knowledge of, among other things, safety, function, automation, sterilisation, development and method development. Together with our customers, we can accelerate development and make a big difference for many people,” concludes Joakim Håkansson.