Once considered the work of science fiction, regenerative medicine is now showing real potential in treating a range of health conditions by effectively enabling the body to heal itself, offering treatments for conditions ranging from arthritis and diabetes to heart valve diseases and damaged retinas.
Collaborations between businesses and universities are integral to these advances in the Netherlands, leading to the formation of spin-out companies specializing in biomaterials or regenerative therapies.
At the center of breakthroughs in this field is an organization based in the highly innovative province of Brabant. Smart BioMaterials Consortium (SBMC) is supporting companies and projects to speed up the time to market regenerative therapies.
“Regenerative medicine will create real disruption in healthcare in the next ten to 15 years,” predicts Jan Rietsema, director of SBMC.
Supporting the development of regenerative therapies
Developing regenerative therapies takes years of scientific research and experimenting, eventually followed by clinical trials. In the early stages, therapies are unlikely to generate any revenue, while at the same time incurring costs. For this reason, these potentially life-saving projects require support.
SBMC is going to considerable efforts to help regenerative companies and projects achieve their full potential. The organization is offering developers of regenerative therapies and biomaterials the opportunity to reduce operations costs by using shared facilities and equipment to refine products and processes.
“We are offering companies shared development facilities, a laboratory, and a pilot production facility, and those facilities can be used by companies to bridge the gap between research and production,” adds Rietsema.
“They can use the facilities with their staff, engineers, and experts, but they can also use the expertise of SBMC. We are in contact with companies that are producing biomaterials and have a strong interest in using them for medical applications that don’t have their own facilities for cell culture experiments.
“They can come into the SBMC cell laboratory and collaborate there. Their material engineers can collaborate with our cell engineers to study and work on cell-material interaction – and that will accelerate their development process because they don’t require their own cell culturing activities.”
Entering the regenerative therapies market
While proving a regenerative therapy on a lab scale and in a clinical setting may be achievable, it is another matter entirely to scale this up to manufacturing. This is also an area where SBMC is looking to support companies and projects.
Rietsema predicts that some of the companies involved with SBMC are realistically going to enter the market within the next three to five years, with more to follow.
A prime example of SBMC bringing different partners together is a project that will create regenerative stents to treat patients suffering from critical limb ischemia. The condition causes acute blockages of arteries in the lower extremities, severely restricting the flow of blood to the feet of the patient.
To address this, Corbion, STENTiT, and Vivolta are collaborating to produce clinical-grade stents made from bioresorbable nanofibres. The aim is for the endovascular support device to enable the natural regeneration of the artery, healing from within and quickly restoring blood flow. Stents are then broken down naturally by the body over time. Hopefully, these stents will avoid the need for hundreds of thousands of amputations every year for sufferers of critical limb ischemia.
Brabant-based company Xeltis has also benefitted from SBMC’s support and is making significant progress in regenerative medicine. Using an approach called endogenous tissue restoration, Xeltis manufactures restorative cardiovascular devices. Heart valves are made from biodegradable polymers that are implanted in the body and naturally grown over by tissue and cells. The company is currently undertaking clinical trials as they edge closer to commercial production.
“They are really at the point to start to make the change from research and development company to more production-oriented company,” adds Rietsema.
“Some other companies are a little bit further away from introducing to the market, maybe five to seven years. A lot of things are coming in the next ten years.”
Building an ecosystem for regenerative medicine
According to Rietsema, the long-term goal of SBMC is to establish a complete ecosystem for regenerative medicine within the Netherlands. This plan centers on four regenerative medicine production lines, known as RegMed XB National Pilot factory.
Alongside biomaterials being developed in Brabant, there is a focus on cell culturing in Leiden, South Holland. In Utrecht, they are specializing in bio-fabrication and making tissues out of stem cells, while in Maastricht they are concentrating on automation in the fabrication of organoids and complex structures.
The idea is that these four pilot lines will unite to enable the Netherlands to cover the vital core areas of regenerative medicine development and offer enhanced opportunities for collaboration within a national pilot factory.
“We are offering a proposition where companies can develop and create regenerative therapy from A to Z. We are building an international proposition with four pilot lines,” explains Rietsema.
The plan is to attract interest and investment from other companies and government agencies around the world, with support from Brabant Development Agency.
“There is a strong knowledge base in Brabant. That is the reason why we are based here,” says Rietsema. “We are an open consortium and open for companies from other parts of the Netherlands, and we can also offer our services to the international community.”