We recently learned of a tragic incident in which a patient at a clinic in Tokyo, who had received a stem cell administration, passed away from what is believed to have been anaphylactic shock. The Ministry of Health, Labour and Welfare has ordered the clinic in question, along with the affiliated institutions that supplied and cultured the cells, to suspend the provision of stem cell therapy.
Anaphylactic shock is a severe allergic reaction caused by an excessive immune response. While extremely rare, it can occur with the intravenous administration of any medication. Because it can progress to a severe state within minutes of onset, a prompt and appropriate initial response is essential in a clinical setting.
To prepare for such risks, our clinic has established a detailed emergency-response manual and staffs physicians and nurses with extensive experience in acute care and emergency medicine. We also thoroughly manage the complete removal of antimicrobial agents during the culturing process, and we conduct patch tests in advance for patients with a history of drug allergies, taking every precaution to ensure safety.
Our Measures Against the Risk of Pulmonary Embolism from Stem Cell Administration
The most dangerous side effect of stem cell therapy — pulmonary embolism, in which administered cells become lodged in the pulmonary capillaries — is believed to result from administering large quantities of degraded cells that have lost their differentiation potential, or cells with low viability.
Our clinic takes the following measures and will continue to enforce them thoroughly.
· We prioritize safety over cell yield, using a multilayer two-dimensional culture method — rather than three-dimensional culture — which carries a lower risk of inflammation and mixed-in degraded cells.
· Cells are cultured at our own facility, registered with the Ministry of Health, Labour and Welfare as a specified cell-processing facility, minimizing the time between collection and administration.
· Before administration, we thoroughly perform visual inspection and imaging under a microscope as part of our quality control.
· We never administer a large volume of cells at once, and we adhere to safe dosage amounts.
(We would also note that caution is warranted regarding the credibility and risk of any medical institution that claims to administer cells on the order of hundreds of millions at once.)
Our clinic and our culture team will continue to make ongoing efforts to further improve safety and strengthen our systems, so that patients can continue to receive treatment with peace of mind.
BiOStyle Clinic Ginza
