Regenerative Medicine

Biofabrication is the creation of functional tissues to regenerate or repair the body’s damaged or diseased organs. The production of these tissues should be standardized for clinical relevance and is often pursued by various forms of 3D bioprinting. Examples are:

• scaffold with living, contracting cardiac cells that is placed on the outside of the injured heart muscle, thereby providing functional support to the damaged heart muscle
• layered plug for cartilage damage that is inserted in the bone and cartilage, which will induce integration of the implant in the recovering tissue.
• combined biological and technological device that aids the removal of waste products for kidney patients, improving or even surpassing dialysis technique.

To effectively treat or even cure a disease, a thorough understanding of it is essential. Currently, many medications are based on suboptimal or imperfect models, resulting in drugs that are only moderately effective for the average patient. Therefore, new disease models are developed to enhance our understanding of the human body, its diseases, and potential cures.

• The discovery of organoids by Hans Clevers lab in Utrecht catalyzing significant advancements in the drug development process. These three-dimensional mini-organs, created from adult-specific stem cells, closely mimic the structure and function of the organs they originate from. While initial breakthroughs were made with intestinal organoids, today there are organoid equivalents for various tissues including kidney, liver, skin, brain, lung, eyes, and many others.
• Although organoids are useful for research, they are already used for clinical purposes as well. For cystic fibrosis (CF), Jeffrey Beekman, professor of cellular disease models and his team showed that intestinal organoids from CF patients respond differently to different treatments. This led to the forskolin-induced swelling (FIS) test, which helps predict which treatment works best for each patient. The test is now included in Dutch CF guidelines and is an example of how organoids can support personalized medicine. 
• The National Growth Fund Ombion aims to improve and accelerate the transition of new biomedical innovations to patients and users, at lower costs, and without the use of animals. This will lead to safer, more effective, and better medicines while reducing animal testing.

Advanced Therapy Medicinal Products or ATMPs are a novel class of interventions for human use that are based on genes, tissues, or cells. They offer groundbreaking new opportunities for the treatment of disease and injury. But they are often personalized products, reflecting or benefiting one or a few patients, and their production often requires two-directional transport of living cells or tissues. This asks a lot from supply chains but also from a privacy and regulatory standpoint.

• The Innovation Center for Advanced Therapies (ICAT) is a pilot plant for the development of GMP and SMP standards.
• (early) Health Technology Assessments to inform product development and decision makers.
• An example of a cell therapy moving to the clinic is a knee cartilage treatment developed by orthopedic surgeon Roel Custers and his team. The treatment combines a patient’s own cartilage cells with donor stem cells and is tested with patients in the IMPACT study.
• Another new cell therapy treats fistulas that can occur after esophageal surgery, developed by plastic surgeon and professor Henk Coert and his team. It uses regenerative cells from the patient’s own fat tissue, combined with their own blood plasma, and is performed in a single procedure. The first patients have been successfully treated, showing the potential of cell therapy for complex conditions.