Manufacturing living body parts for the patient
From growing human tissues and organs using stem cells to curing several unmet medical needs with cell therapies, regenerative medicine is a hotbed of innovative research worldwide. It is believed by many, to be the future of medicine and healthcare. Interest in the field is driven by its potential to offer solutions for several unmet medical needs such as cancers, diabetes, congestive heart failure, Parkinson’s disease, Alzheimer’s disease and spinal cord injuries. And by the need for a sustainable healthcare system.
Regenerative medicine aims to give patients a therapy that has a regenerative capacity. A molecule, cells, a biomaterial, a piece of tissue or a whole organ, with the intention not to slow down a disease or keep it stable, but to give the body a trigger to regenerate. A trigger that will restore the injured or diseased body (part) in its original state. From a science and technology point of view, regenerative medicine is at the intersection of biology, physics, chemistry, mechanics and engineering. It embraces several research areas, such as cell therapy, tissue engineering, biomaterials engineering, growth factors, transplantation science, artificial intelligence, quality and manufacturing technologies. It’s a very broad field looking into medical devices, artificial organs, tissue engineering and biomaterials, cell therapies and drug development technologies.
Right at the beginning
“Today, regenerative medicine is in its infancy, right at the beginning”, says Jan Schrooten, co-founder and CEO at Antleron and coordinator of the Regenerative Medicine Innovation Platform (RegMed), an open community to drive regenerative medicine towards a real industry with clinical applications and socio-economical return. At KU Leuven he co-founded and managed Prometheus, a cross-disciplinary research group with the vision to bring regenerative implants for children with non-healing bone defects from the lab to the patient. “A lot of great inventions are in the labs today, but the challenges to translate them from the lab to the patient remain enormous for various reasons. It requires far-reaching interdisciplinary collaboration between industry, academia, hospitals and governments to adapt the legal, regulatory, clinical and socio-economical frameworks to enable the translation of regenerative concepts to the patient. No copy paste is possible from the existing models of e.g. pharma or biotech”, explains Jan.
Some regulators are leading the way by providing a myriad of ways to support companies in this sector. “The UK has set up its national Catapult model where the government is investing to advance the field of regenerative medicine and aiming for a return to society. This is envisaged in various ways through long-term vision and commitment from both government and other stakeholders.” Japan has an innovative approach to regulate advanced therapies. “In Japan you can bring cell therapy or regenerative medicine faster to patients with life threatening, debilitating conditions with no available alternative treatment. It allows companies to gather the real world evidence they need and at the same time help patients. That’s why you also see that many European companies, and many cell therapy companies from here now have a Japanese partner, because they can get to the patient more easily than here. At the same time these partnerships offer Japanese stakeholders early access to pioneering skills, know-how and regenerative products, thus creating a real win-win”.
Today and tomorrow
It will be another 20–30 years before the full potential of regenerative medicine probably will be realized. For the near future, much of the research in this area remains confined to the lab. We are at the level today that for certain biologies, tissues and organs there is enough biological understanding to quantify and use that knowledge in engineering regenerative solutions. You start seeing cells as living medicines, with a number of companies that are already going to the clinic, a number are already on the market. There are also a few tissue engineering products. “You see today isolated cases of clinical applications of tissue-engineered skin for skin replacement and tissue-engineered bladder, derived from a patient’s own cells that are grown outside the body and transplanted. Tomorrow, we will not replace half a leg, but researchers and companies focus now on patients with a severely damaged bone biology. If we can take out the bad biology and insert something new, we can reboot the biology. I believe that in the future we will be able to repair injuries and diseases. In 10-15 years, a living heart valve or a lung should be feasible. Interest in regenerative medicine is also driven by drug development, where engineered stem cells and tissues at lab scale can be used for (personalized) drug screening and drug safety testing”, said Jan.
To the clinic
Jan’s vision is to sustainably bring ‘living implants’ into the clinic. To realize that he needs to address suitable manufacturing paradigms. “We want to create blueprints that enable tissue manufacturing for patients. One of the problems with tissue engineering is that you have to make clinically relevant volumes. A piece of lung, a piece of liver, a piece of bone or skin, they are not cubic millimeters. The many things that can be done on a very small scale in the lab, need to be scaled up, over different length scales. It is not that if you have shown proof-of-concept in a lab or in a small animal model, that you can do a cubic centimeter tomorrow and the next day a fist large organ or living implant. There come, apart from regulation, ethics and economics, also the laws of physics, mechanics, that is not just biology. That makes it complex.”
It’s not a secret that no one single organization is going to solve these challenges on their own. Collaboration and consolidated effort are key to making regenerative medicine a reality. “If there is one region in Europe able to overcome the challenges of regenerative medicine it is the region of Belgium and The Netherlands. All pieces of the puzzle are present, the robust ecosystem is really working here. It’s the hotspot for basic research, biotech, pharma, clinical trials, engineering, including the pioneers for 3D printing and micro-electronics innovation in Europe. The first cell therapy company that got regulatory approval from EMA and went to the market in Europe, TiGenix, is located here. It won’t mean we will have solutions tomorrow, but by having enough critical mass and complementarity, together we can bring solutions closer to the patient, including the help of big players like Johnson & Johnson. They are also watching the field and look at regenerative medicine as a new technology platform next to classical drugs, biologics and vaccines. I hope they will also be including cell-based therapies in the future.”