Mesenchymal stem/stromal cells (MSCs) are emerging as a promising tool in cell therapy due to their strong immunomodulatory and anti-inflammatory properties, their capacity for tissue regeneration, and a favorable safety profile. Unlike other cell-based therapies, such as CAR T cells that may trigger severe immune responses like cytokine storms, wild-type MSCs have shown no such adverse reactions when administered to humans. However, the widespread clinical application of MSCs has been limited by challenges in producing therapeutically effective cells consistently and at scale. To date, only one MSC-based therapy has been approved by the U.S. Food and Drug Administration (FDA).
A key obstacle in developing MSC therapies is the ongoing requirement for new tissue donations from various donors. This dependence leads to high variability and restricted batch sizes due to the limited expansion capacity of each donor-derived sample.
Continue reading… “Advancing MSC-Based Therapies: Overcoming Manufacturing Barriers with the Cymerus Platform”