Safety Considerations: Tumorigenicity Risks
Risks with Pluripotent Cells
A significant challenge with pluripotent stem cells is their potential to form teratomas (a type of tumor) if any undifferentiated cells remain after treatment. This risk demands extremely careful preparation and strict quality controls before clinical use. Pluripotent stem cells require ideal lab conditions to avoid unwanted genetic mutations. If these cells have been used and recultivated over many years, it is likely they have exceeded the typical 10 to 20 passages—one cycle of splitting and reculturing cells—and should be verified by an independent ISO-certified lab to ensure genetic integrity and to protect patient safety. Advantages of Multipotent Cells At LMI, patient safety is our utmost priority. We exclusively use multipotent cells at passage 4—meaning they have been minimally recultivated—thereby significantly reducing any risk of unwanted genetic mutations. This rigorous approach ensures that our cells maintain the highest quality and integrity for clinical use, setting the standard for safe and effective treatments. Our strict lab protocols and ongoing quality control measures guarantee that every batch of cells meets rigorous safety standards, providing the best possible outcomes for patients.
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