Stem Cells – New Medical Miracle?

In a small laboratory situated in Stockholm, Mattias Bernow is pioneering what could be considered a modern miracle – the mass production of stem cells. These stem cells, when infused intravenously or injected into specific tissues, have the potential to revolutionize the treatment of a wide range of medical conditions, from cardiovascular diseases to cancer, Type 1 diabetes to Alzheimer’s and Parkinson’s, and even infectious diseases like Covid-19.

Describing this innovative approach, Bernow likens it to medicine, enhanced with the power of artificial intelligence (AI). The remarkable feature of these stem cells is their ability to listen to the signals emitted by the body and determine precisely what actions are needed for a particular patient. For example, individuals suffering from heart disease could receive stem cell injections directly into the heart muscle, with the new cells contributing to the repair and regeneration of damaged tissue. Bernow believes that these cutting-edge cell therapies might achieve for chronic diseases what antibiotics did for infectious disorders.

However, there’s a significant challenge that needs to be addressed – the cost and complexity of obtaining high-quality stem cells. Yet, companies like the one led by Mattias Bernow are actively working to change this reality.

Making Stem Cell Therapies Accessible to All

As the CEO of Cellcolabs, Mattias Bernow is at the helm of a groundbreaking venture that was established in 2021. This endeavor, spearheaded by seasoned healthtech entrepreneur Per Båtelson, impact foundation Norrsken, and Katarina Le Blanc, a renowned professor of clinical stem cell research at the Karolinska Institute in Stockholm, aims to reduce the cost of advanced cell therapies by embracing mass production of stem cells. This process, while complex, has the potential to transform the landscape of medical treatments, enabling middle-class patients to access cost-effective therapies and paving the way for large-scale clinical studies.

In Bernow’s words, “If you are a National Hockey League professional or a movie star, you can already afford to get a cell therapy treatment in Mexico, the Bahamas, or Panama, but it will cost tens of thousands of euros.” The vision is to make these innovative treatments accessible to middle-class individuals worldwide.

Cellcolabs intends to produce 1,000 to 2,000 high-quality batches of stem cells annually, with the assistance of 10-15 young, healthy bone marrow donors. The process involves obtaining 50 ml of bone marrow from these voluntary donors, isolating the stem cells, storing them in small containers, and replicating them numerous times. After a thorough quality check, these batches undergo controlled cryopreservation, with the cells gradually frozen from slightly below freezing to just short of minus 200°C before they are ready for shipment.

The Potential of Cellcolabs

Cellcolabs is actively engaged in conducting clinical studies in Abu Dhabi, focusing on age-related fragility and knee osteoarthritis. Soon, they will initiate clinical studies in the Bahamas, targeting sports injuries and disease prevention. Beyond this, the company’s clientele spans various domains, including fundamental research and drug development for neurological disorders. Mattias Bernow firmly believes that by reducing the cost and improving accessibility to stem cells, Cellcolabs will expedite the adoption of stem cell therapies for patient treatment and accelerate research in this field.

The funding for Cellcolabs has been bolstered by the Norrsken Foundation and several angel investors, including co-founders of Voi and Kry, Johannes Schildt and Fredrik Hjelm, who have collectively invested €4 million in the enterprise.

The Advancements in Stem Cell Production

Another company actively contributing to the field of stem cell production is TreeFrog Therapeutics, a French firm that employs bioreactors for this purpose. In its earlier stages, TreeFrog focused on induced pluripotent stem cells, which can be intentionally reprogrammed from skin or blood cells into an embryonic state and subsequently guided to develop into any type of human cell required for therapeutic applications. These cells could be differentiated into neurons for neurological conditions, blood cells for treating leukemia, or insulin-producing cells for diabetes. However, they faced a common challenge among cell producers – the fragile nature of living cells, which can be easily damaged during bioreactor production.

TreeFrog’s unique solution is a biomimetic hydrogel-like coating technique, which allows the high-volume production of various cell types without compromising quality. Rather than selling their cells to research centers, TreeFrog is collaborating with select partners to develop cell therapies in-house. After securing a funding round of $75 million in September 2021 to enhance its technology, the company is now working on a partnership to encapsulate NK cells, also known as killer cells, which are utilized in cancer treatment. Furthermore, TreeFrog is advancing internal clinical programs, focusing on Parkinson’s disease. The first of these programs is expected to enter human testing in 2025.

Ethical Considerations in Stem Cell Research

The field of stem cell research and therapies has been underpinned by certain ethical considerations, often stemming from the association of this research with other, more morally contentious fields of medical study, such as the use of embryos and cloning. Cellcolabs largely sidesteps these ethical concerns by relying on stem cells donated by young, healthy individuals. However, the overarching skepticism around the field of stem cell research has slowed its progression within Europe. Mattias Bernow emphasizes the importance of conducting more clinical research in this area, which, in turn, can make these treatments more widely available.

The Slow Path of Regulation

A contributing factor to the relatively slow pace of progress in the field of stem cell research is the rigorous regulatory environment. Regulatory agencies like the FDA in the United States and the European Medicines Agency (EMA) are recognized for their cautious approach to novel therapies. While this regulatory diligence is well-founded, Bernow believes that it might hinder advancements in the field. Bone marrow-derived stem cells have been under investigation for over two decades, and thus far, there are no reported serious adverse effects associated with their use. Bernow remains hopeful that as a sufficient body of robust clinical studies accumulates, the benefits of using these cells will become more evident, potentially prompting regulatory changes.

Additional Players in Stem Cell Production

TreeFrog and Cellcolabs are not the only players in the stem cell production arena. Other notable entities include UK-based biotech firms Ori Biotech and MicrofluidX. The latter is working on the development of a microfluidic platform capable of producing cell and gene therapies.

Furthermore, a breakthrough discovery has emerged from LifeWave, a US-based company. They have developed a patch, as described by founder David Schmidt, that has the potential to rejuvenate a person’s natural stem cells and stimulate the production of new stem cells. This innovation is particularly significant, as natural stem cell production in the human body nearly ceases after the age of 50. Notably, these stem cell patches are available to the general public without the need for a prescription.

In conclusion, the field of stem cell production and therapy is poised for transformative growth, with companies like Cellcolabs and TreeFrog Therapeutics at the forefront of these advancements. By making high-quality stem cells more accessible and affordable, these enterprises are working towards a future where stem cell therapies become commonplace for a broader range of medical conditions. As the regulatory environment evolves and more clinical research is conducted, the potential benefits of stem cell therapies will become increasingly evident, shaping the landscape of healthcare in the coming years.