Lindsay Davies, Chief Scientific Officer at NextCell Pharma AB, sees significant potential for stromal cell therapies in autoimmune and inflammatory diseases, particularly because of their ability to respond dynamically to the biological environment around them.
Unlike therapies built around a single mechanism of action, stromal cells can sense the patient’s immune environment and respond in different ways to help restore immune balance. This adaptability creates the potential for a broader platform approach across multiple autoimmune and inflammatory conditions.
The Challenge Is Consistency
One of the biggest barriers, however, is product variability.
Mesenchymal stromal cells can differ according to the donor, tissue source, manufacturing process and length of expansion. These factors can all influence potency and clinical efficacy, making it difficult to compare results between studies.
Davies highlighted the importance of greater standardisation and regulatory alignment so that researchers, clinicians and regulators are comparing genuinely comparable products rather than therapies grouped under the same broad name.
Manufacturing and Potency Matter
As stromal cell therapies move into larger clinical studies, stronger transparency around manufacturing, characterisation, potency testing, quality control, storage and handling will become increasingly important.
Better reporting could help regulators and researchers identify which factors most strongly influence clinical outcomes and support the development of more consistent next-generation products.
A Platform for Combination Therapies
Looking ahead, Davies sees particularly strong potential for using stromal cells alongside other therapeutic approaches.
Their immune-modulating properties could make them valuable partners for CAR-based therapies, regenerative medicines and other cell therapies. For example, stromal cells could potentially help dampen damaging immune responses while another therapy targets the underlying disease or supports tissue regeneration.
The next phase for the field will therefore depend not only on proving efficacy, but on improving consistency, regulatory clarity and collaboration across the cell and gene therapy ecosystem.
