Recently, there have been several nationally published articles concerning the use of postnatal stem cells and the governing regulations of the FDA. The FDA has acknowledged that stem cell products have the potential to treat many medical conditions and diseases and have strict regulatory restrictions in place and often review manufacturers processes and procedures for compliance.
As part of the FDA’s review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the product’s safety, purity, and strength (potency).
We are proud of our 14-year history of remaining compliant without any violations issued.
Through our strict processes, we take every precaution available to ensure that our products are safe, in their purest form and maintain the highest quality of potency.
Collection of Postnatal Donation A Recovery Specialist, once given the donation information from the Director of Procurement, will collect the postnatal donation at the designated hospital. The Recovery Specialist will then return the donation to UCB to be processed.
Donor Eligibility Requirement Our proprietary process begins with a meticulous screening of the donor mother and father as well as family members for several generations. In addition to routine industry screens for bloodborne pathogens, we also screen for heritable and non-heritable conditions, environmental contaminants from medications, alcohol, drugs, tobacco and electronic vaping. Only healthy families who meet or exceed these criteria are considered. Postnatal tissues can be collected within 30 minutes of a Cesarean section. After processing, allografts are tested again to ensure they are free of contaminants or infection and contain healthy, viable cells prior to cryopreservation.
Testing Procedures Include:
Diseases that are tested prior to donation eligibility:
Processing this proprietary process meets the FDA’s requirements being minimally manipulated, include:
(1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue related to the tissue’s utility for reconstruction, repair or replacement; and
(2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
(3) Transfer means the placement of human reproductive cells or tissues into a human recipient.
Cryopreservation: We use a unique cryopreservation technique that includes using the donation’s own natural components integrated with a natural cryoprotectant to help ensure maximum functional cells post-thaw for homologous use.
Shipping Our products are shipped overnight in cryopreserved authorized shipping containers. Products are shipped only to licensed medical professionals.