Stem Cell Safety

The allogeneic human Umbilical Cord Blood-derived Mesenchymal stem cells (MSCs) known as hUCB-MSCs are produced in commercial Good Manufacturing Process (GMP) in a USA, FDA approved GMP which produces hUCB-MSCs from cord blood. The process of manufacturing the hUCB-MSCs from cord blood takes about 4 to 6 months. The HUCB-MSCs can be used by any patient regardless of blood type, age, sex or ethnicity. The hUCB-MSCs to treat patients are live cells and must be used within 72 hours from GMP release.

USA-FDA approved safety trial done in USA proving safety of an allogeneic, human, umbilical cord blood-derived mesenchymal stem cells hUCB-MSCs that are used to treat patients: Publication in Orthopedic Journal of Sports Medicine

Collaborating efforts between MEDIPOST and Samsung Medical Center resulted in the successful development of an allogeneic Umbilical Cord Blood (hUCB-MSCs) – Through rigorous research and development since 2001. The derived hUCB-MSCs from cord blood product approved by the Korean Regulatory Authority (MFDS) (Korean FDA) in January 2012.

Safety

The hUCB-MSCs produced by Medipost have been declared safe by the USA, FDA in a safety trial. The hUCB-MSCs have been used in Korea since 2012, and until present 35,000 patients have been treated without one reported case of an adverse reaction.

PMDA (Pharmaceuticals and Medical Devices Agency) the Japanese regulatory agency has accepted the safety of the hUCB-MSCs manufactured by Medipost.

The mother’s blood is tested for all communicable diseases before processing the cord blood. This is vital, as the baby’s blood is too young to have formed anti-bodies. The hUCB-MSCs are manufactured and prepared in Korea from the stem cells isolated from the umbilical cord blood of healthy newborns, donated by their parents. It is important to stress that The GMP is audited on a regular basis by the Korean Regulatory Authority (MFDS, Korean FDA).

Umbilical Cord Blood (UCB)

Umbilical Cord Blood (UCB) is a fresh source of effective adult stem cells, which are considered the most ethical because cord blood is regarded as waste tissue and is considered as adult stem cells. The use of UCB stem cells is endorsed by religious groups, including the Roman Catholic Church.