Safety of Stem Cell Therapy
BHI Stem Cells has taken every precaution to ensure the safety and viability of administered stem cells. The umbilical cord is collected from primiparous pregnant women receiving a Caesarean section in accordance with the sterile procedure guidelines in the hospital. The pregnant donor women pass medical examinations before they donate the umbilical cord. In compliance with Good Tissue Practice, they tested for communicable diseases. After isolation of Human Umbilical Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells, the following tests are performed to ensure the safety and quality of cells: Virus Tests (Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency virus and Treponema pallidum), Microbiological Tests (Bacteria, Fungus, Mycoplasma, Endotoxin), the cell count and viability.
Our long-term safety study of research subjects, who received human umbilical cord blood and tissue stem cell therapy, is underway. Administration routes included intravenous infusion and intrathecal injection. Short-term follow-up results indicate, that subjects did not develop adverse effects, further demonstrating the safety of the 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. The results indicate that 29 research subjects did not develop related to therapy adverse effects/medical conditions 4-7 years after stem cell administration and both intravenous and intrathecal administration routes are safe.