Paramount is our commitment to patient safety and stem cell quality. All foundation products are manufactured directly, unlike many of our competitors who buy and repurpose umbilical cords. To maintain an unbroken chain of custody we collect the umbilical cords directly from qualified voluntary donors immediately after birth. The cord blood, Wharton’s Jelly and other cells are then processed, tested, and certified before being made available to medical professionals that we know and trust.
Unbroken Chain of Custody
STEP 1: Voluntary Donation and Prescreening
Every mother who volunteers to donate their umbilical cord upon her child’s birth must complete a detailed prescreening questionnaire to prequalify for participation. Initial blood testing of the mother is necessary to pre-qualify. (First round of blood tests.)
STEP 2: Collection and Testing of Umbilical Cord
After the donor gives birth, the umbilical cord is collected and sent to our laboratory for processing and testing of infectious diseases. (Second round of blood tests.)
STEP 3: Processing and Final Testing
The umbilical cord cells are then separated and purified. Test samples are taken as cells are prepared for cryopreservation. All frozen cells remain in quarantine until the tests come back free and clear of all infectious diseases. (Third round of testing.)
STEP 4: Certification & Distribution
Once the certification process is completed, the stem cells and other cellular products are made available to patients
New cGMP Facility
The Foundation utilizes a new, state-of-the art cGMP (current Good Manufacturing Practices) facility in California to produce our stem cells and other cellular products. This nearly 10,000 square foot facility also serves as our research and development operations and houses multiple clean rooms, a flow cytometry core, and ultracentrifuges.