“Beyond the Culture: Handling Challenges in Cell Therapies”
Quality from Culture to Patient Care
Cell therapy management extends beyond cultivation. Delivery and storage are critical phases that can directly impact treatment quality and effectiveness. This article explores factors such as cell concentration, gravitational aggregation, transport solutions, time out of culture, and cell age. It also offers practical recommendations and emphasizes the need for standardized protocols. At Baja Regenerative, we are committed to optimizing these processes to provide safer and more consistent results.
Between Acceptance and Skepticism
Currently, the acceptance and use of cell therapies face resistance from certain groups, including both healthcare professionals and the general public. The reasons vary, but misinformation and lack of knowledge are prominent. However, an even more critical factor is how poorly standardized these therapies are. This variability in outcomes is one of the main reasons why there is still no clear regulation, at least in our country.
Logistics and Standardization: A Pending Challenge
One of the least discussed—but highly relevant—aspects of cell therapy is what happens after cell culture: how doses are prepared, stored, and transported until administration. This process is far from a mere logistical formality—it is a critical link that can directly influence treatment effectiveness. The lack of standardized protocols in this stage produces variable results, affecting trust in and acceptance of these therapies. It is crucial to advance the standardization of these procedures with the same rigor applied to cell culture.
Cell Quantity and Gravitational Aggregation
Typically, cell therapy doses are delivered in vials containing a wide range of cell counts—from 100,000 up to 226 million, with a reported average of 4 million. This variability can impact quality. Without constant agitation, cells tend to settle and aggregate due to gravity, reducing viability. Interestingly, smaller cell numbers tend to preserve better migratory capacity.
Transport Solutions and Temperature
Regarding transport solution and temperature, cryopreservation—although useful—is not the optimal choice. It requires additional steps (freezing and thawing) that do not always preserve cell viability. Therefore, several groups have studied the use of hypothermic solutions, including:
– Saline solution (0.9% NaCl)—the most frequently cited in the literature.
– Dextrose
– Plasmalyte
– Hartmann’s solution
These solutions, when maintained at 4°C, help minimize cellular viability loss. However, even under these conditions, a drop of up to 60% viability after just 2 hours outside of culture has been documented, below the 70% minimum set by the FDA.
Time Out of Culture and Cell Age
The therapeutic success of MSCs depends on their proliferation, differentiation, and immunomodulatory capacities—all of which decrease with time outside of culture. Moreover, viable cells can enter senescence. Cell culture age is also relevant: while MSCs can maintain identity up to 16 passages, their therapeutic potential diminishes. Conversely, using very young cultures may trigger a more intense immune response in the recipient.
Recommendations and Logistical Alternatives
Given the above, it is recommended that clinics offering MSC-based therapies have their own culture room or partner with a nearby provider. This avoids cryopreservation and reduces the time between culture and application. Some authors suggest administering treatments within 6 hours, not exceeding half a day. While this may be challenging in practice, continued research is needed on the effects of hypothermic solutions on MSCs from various sources, considering their functional variability.
Do you want to ensure the highest quality in cell therapies?
At Baja Regenerative, we work under the highest standards to ensure that every dose of cell therapy meets strict criteria for quality, safety, and viability. If you are a physician, researcher, or clinic looking to implement cell therapies responsibly, our team is ready to assist you.
Contact us today and discover how we can help optimize your delivery and storage protocols to improve clinical outcomes and patient trust.
References:
Chen Y., Yu B., Xue G., Zhao J., Li R., Liu Z. y Niu B. (2013). Effects of storage solutions on the viability of human umbilical cord mesenchymal stem cells for transplantation. Cell Transplantation. 22: 1075-1086.
Ściezyńska A., Soszyńska M., Szpak P., Krześniak N., Malejczyk J. y Kalasczyńska I. (2021). Influence of hypothermic storage fluids on mesenchymal stem cell stability: A comprhensive review and personal experience. 10 (1043).
Sultana T., Dayem A., Lee S., Cho S-G. y Lee J. (2022). Effects of carrier solutions on the viability and efficacy of canine adipose-derived mesenchymal stem cells. BMC Veterinary Research. 18: 26.
Wang Y-H., Tao Y-C., Wu D-B., Wang M-L., Tang H. y Chen E-Q. (2021). Cell heterogeneity, rather than the cell storage solution, affects the behavioor of mesenchymal stem cells in vitro and in vivo. Stem Cell Research & Therapy. 12:391.
