In an interview highlighting the intersection of scientific research and lived experience, Mina Brimpari, Scientific Project Manager, shares insights into her role in the ISLET project. ISLET is a pioneering EU Horizon 2020 initiative, aiming to develop stem cell-derived beta cells as a restorative therapy to replace the beta cells destroyed by type 1 diabetes. The project which is expected to complete around the end of 2025 is a multi-institutional collaboration, with partners bringing together expertise in stem cell biology, lipidomics, proteomics, islet biology, computational biology, GMP manufacturing and clinical islet transplantation and lived experience of diabetes.
Mina’s specific role in the project is to adapt the existing protocol for producing glucose-responsive beta cells to generate a reproducible, sustainable and GMP*-compliant cell protocol that will pave the way for initial human clinical trials.
Mina explained how they manufacture therapeutic cells. “First, stem cells** are grown in a flask in a tissue culture room, and then a series of growth factors and chemicals are added, eventually leading to these cells become beta cells”. She added that thereafter, the process becomes more regulated. “The idea is that we take these beta cells and grow them in an environment, like a good manufacturing practice facility, to follow manufacturing standards to grow the cells at scale.”
Key challenges: robustness and scalability
When asked about the biggest hurdles, Mina was clear:
“the biggest challenge is to develop a robust protocol so that every time that you differentiate cells, they become beta cells. While the differentiation*** protocol itself takes about a month, developing a reliable, scalable system can take years.”
Scalability is another major issue. To produce cells at a scale suitable for clinical or commercial use involves a lot of optimisation. She mentioned that scalability is of major importance, with the key question being how to generate enough cells such that you have a therapeutic product.
Involving People with Lived Experience
Mina also emphasised the importance of including those with type 1 diabetes (T1D) in research efforts: She mentioned that in her team, one scientist lived with T1D. She added that this enables the team to get insights into how difficult it is to regulate insulin and that “it gives you motivation”. She believes these collaborations offer scientists a broader perspective and that they need people with T1D to work in these projects. She saw having IDF Europe as a partner within the ISLET consortium as beneficial to the scientists to see the big picture.
Looking Ahead
When asked where she sees the ISLET project in 10 years, Mina expressed cautious optimism: “I want to have the first clinical studies, like phase one and phase two, and also to have some promising, meaningful clinical data.”
She also highlighted the evolving regulatory landscape:
“Now, we see from the Food and Drug Administration (FDA) or European Medicines Agency (EMA) that they understand the importance of cell therapy… CAR-T cells is the driving force for developing the regulatory landscape to ensure that cell therapy meets all safety and efficacy standards.”
For more information about the ISLET project, visit the website here: https://isletproject.eu/
* GMP stands for Good Manufacturing Practices, a system that ensures that manufactured products, including stem cell derived therapies, are produced and controlled according to set quality standards.
** Embryonic stem cells are special cells taken from early-stage embryos that can grow into any type of cell in the body. Induced pluripotent stem cells are regular adult cells that scientists have changed to act like embryonic stem cells. This means they can turn into almost any type of cell in the body, which is useful for research and medicine.
*** In the lab, differentiation is when scientists guide stem cells to become specific cell types by adding specific chemicals or changing the environment. This helps researchers to generate the cells they are interested in, like insulin producing beta cells.
