Stem Cells

Stem Cells

We exceed industry standards through comprehensive lot testing protocols.

Sourcing

All birth tissue is bio-ethically donated from healthy, consenting mothers who undergo full-term, C-section deliveries in the United States. Each donor completes a comprehensive medical background check and blood screening process to ensure safety and quality. We exclusively partner with United States-based tissue procurement organizations that follow stringent AATB (American Association of Tissue Banks) guidelines and prioritize maternal and infant safety throughout the collection process. Our commitment to maintaining FDA compliance and AATB standards extends across our entire supply chain, from procurement to processing.

Processing

Our Human Cellular Tissue Products (HCT/Ps) are processed under strict minimal manipulation guidelines to maintain their classification as 361 HCT/Ps. In accordance with 21 CFR 1271.3(f)(1), our processing methods for structural tissue preserve the original relevant characteristics that contribute to the tissue's natural functions. This means the processing does not alter the tissue's inherent properties that are essential for reconstruction, repair, or replacement, and ensures that these vital characteristics remain unchanged from their original state in the donor.

Testing and Guidelines

We exceed industry standards through comprehensive lot testing protocols. Every manufactured lot undergoes rigorous third-party laboratory testing for sterility, endotoxin levels, and environmental factors, conducted by a global leader in pharmaceutical, cosmetic, and environmental testing. Our testing program adheres to stringent USP 71 Sterility Guidelines for detection of all fungi, mold, yeast, and bacteria, while following AATB and FDA protocols for endotoxin evaluation and USP 1116 Environmental Controls. Each lot is also thoroughly screened for an extensive panel of viruses, blood, and tissue-borne pathogens in accordance with AATB and FDA guidelines— including HIV, HBsAg, HCV, HBc Total, HTLV I/II, RPR, HIV/HCV/HBV Ultrio, WNV NAT, CMV Ab, Zika NAT, Lyme Disease, Epstein-Barr Virus, E.coli, Candida, and COVID-19.