Safety of Stem Cell Therapy
BHI Stem Cells has taken every precaution to ensure the safety and viability of the hUCB stem cells administered. Umbilical cord bloods is collected from primiparous pregnant women receiving Caesarean section in accordance with the sterile procedure guidelines in the hospital. The pregnant donor women pass medical examinations before they donate umbilical cord. In compliance with Good Tissue Practice, they tested for communicable diseases such as HBV, HCV, HIV and Syphilis. After collection, each cord blood sample is tested for communicable diseases such as HBV, HCV, HIV and Syphilis. The isolated mononuclear cells are cultured to test for bacteria and fungus, endotoxins, and to insure viability.
Our long-term safety study of 30 research subjects, who received hUCB stem cell therapy, is underway. Administration routes included intravenous (IV) infusion and intrathecal (IT) injection. Short-term follow-up results indicate, that subjects did not develop adverse effects, further demonstrating the safety of therapy. With the application of adverse event/serious adverse event form we are monitoring long-term adverse effects that are possibly related to stem cell therapy. Preliminary results indicate that 17 research subjects did not develop related to therapy adverse effects/medical conditions 4-7 years after stem cell administration, and both IV and IT administration routes are safe.