Stem cells, known for their potential to repair and heal injuries and diseases, are a hot field in biotechnology. A company involved in driving development in the area is Cline Scientific. Through its nanotechnology platform, the Swedish biotech develops a treatment that regenerates cartilage. In this article, BioStock takes a closer look at the stem cell field and where Cline’s project fits into that landscape.
Stem cells are central building blocks of the human body. They have the ability to self-renew and develop into different mature cell types. Their properties make them an interesting area of medical research, with the potential to repair or replace tissue that has been damaged by disease, trauma, or aging.
The research field can be broadly divided into two areas, multipotent mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs). Additionally, there are also embryonic stem cells, which have the ability to differentiate into all cell types in the body, and adult stem cells, which have a more limited ability to differentiate.
Going back to MSCs, they are found naturally in our bodies and have the ability to develop and differentiate into bone, cartilage and adipose tissue, among others. These cells can be taken from the bone marrow, among other places, and then cultivated in laboratories and finally transplanted to damaged or diseased areas of the body.
New technology unlocks great potential
With new technology, it is now possible to reprogram functional cells and turn them into so-called iPSCs. The P stands for pluripotent, which means that, like embryonic stem cells, they have the ability to differentiate into any type of cell. In 2012, researchers Shinya Yamanaka and John B. Gurdon were awarded the Nobel Prize in Physiology or Medicine for their discoveries with iPSCs.
By using iPSCs, Gothenburg-based Cline Scientific is developing a cell therapy. The company has developed a patented nano-based surface technology that enables control over the development of cells with extreme precision. On the one hand, the technology makes it easy to identify the environment for optimal stem cell differentiation; on the other hand, it ensures that it is only the selected environment that directly affects the stem cell.
Cline’s first project targets cartilage
StemCART is the project that has progressed the furthest for Cline. Here, the company aims to develop a stem cell product that can regenerate cartilage in human joints, for the treatment of, for example, osteoarthritis.
When the cartilage wears down, the patient becomes sore and is eventually unable to use the joint. The body cannot repair damaged or broken cartilage on its own, so those suffering from this sort of problem are primarily offered various pain-relieving options and cortisone injections. When the symptoms are severe enough, surgery is eventually necessary, where the joint is simply replaced with a plastic and metal joint.
This creates a large treatment gap that leads to great suffering for each patient. There are some cell-based treatments that aim to rebuild the cartilage. However, they are subject to a time-consuming procedure; where cells must be taken from the patient, grown in a lab and then implanted. This is called autologous cell therapy.
This is where Cline wants to come in with StemCART, where the goal is to develop a stem cell-based treatment that can be scaled up for use globally. StemCART is thus being developed as an allogeneic cell therapy, i.e. one can grow large batches of cells, where these cells can be used in many patients without the risk of rejection.
When stem cells develop into organ- and tissue-specific cells, it is done through gradual stimulation from specific biomolecules. When it comes to stem cell cultivation in general, one of the biggest challenges is to create an ideal growing environment that can mimic the natural conditions in the human body. This includes finding the right biomolecules and creating a physical environment that promotes cell growth and differentiation.
In Cline’s nanotechnology, specific biomolecules are attached to gold nanoparticles and to the surrounding surface, creating an environment that mimics the environment in which functional cells normally live. With this technology, the company, in the StemCART project, can differentiate iPSCs with high precision towards cartilage.
Precision is an aspect of nanotechnology that the company highlights as an important advantage compared to existing technology used in stem cell culture. Today’s technology simply lacks the precision needed to fully control the development of stem cells.
Towards phase I
In preclinical trials, Cline has tested StemCART on human cartilage tissue, which has been artificially damaged. The results indicate that the stem cells have developed towards cartilage cells and that they interact well with the existing cartilage tissue once implanted. Right now, the company is preparing for the next step in its development, to take the project into the clinic. The goal is to initiate clinical phase I studies in 2026.
At the same time, the company is working on further completion of the preclinical activities and is also looking for a partner who has enough muscle for the further clinical development phases. According to Cline, such a partner could be a biopharma company, but also a medtech company operating in the field of orthopedics.