Safety of Stem Cell Therapy
BHI Therapeutic Sciences Jamaica follows quality-control procedures for the cells used in its research. 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 quality tests are performed: 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. 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. These cellular products are investigational; their safety and effectiveness have not been established.