EUCYT Safety Standards
Most human tissue products are derived from cadavers and processed by third-party tissue banks. EUCYT believes the use of live, healthy donors is a superior approach to generative healthcare. The placental-derived allografts we recover from live, healthy donors who undergo a pre-screening process during pregnancy, are chosen based on our stringent donor-selection criteria.
From aseptic recovery of the tissue at childbirth, to timely processing of our allografts, EUCYT’s protocols and procedures have been developed to meet, or exceed, all applicable industry standards for the use of human cellular and tissue-based products. Our operating entities are registered with the Food and Drug Administration and accredited by the American Association of Tissue Banks (AATB), American Association of Blood Banks (AABB), and Clinical Laboratory Improvement Amendments (CLIA).
All potential EUCYT donors are screened during an examination of prenatal medical records and test results. A comprehensive medical history and a behavior-risk assessment is obtained from the donor prior to donation incorporating United States Public Health Service guidelines. We set discussions with physicians and/or donor mothers to identify circumstances that may lead to the exclusion of the donor or donated tissue.
Our infectious disease screening requirements meet, or exceed, all Food and Drug Administration requirements.
Our company is registered through the FDA regulatory process. We take the appropriate steps to assure that our products follow FDA standards.
EUCYT products and facilities are accredited and exceed general standards. These standards cover all aspects of operation from donor selection and testing, to product processing, storage, clinical administration, and patient outcomes.