All birth tissues (amniotic fluid, amnion membrane) are recovered from consented maternal donors undergoing Cesarean Sections. The donors are screened and deemed eligible by:
1) Human Birth Tissue/Blood Maternal Risk Questionaire
2) Maternal Health History and Medical Records Review
3) Review all reports/records pertaining to risk factors for relevant communicable disease (e.g., social behavior, clinical signs and symptoms of relevant communicable disease, and treatments related to medical conditions suggestive of risk for relevant communicable disease)Negative blood tests for HIV, HTLV, Hepatitis B, Hepatitis C, Syphillis as required by the FDA
4) Donor’s History & Physical (“H&P”) report at time of C-section, and both donor and infant’s Discharge Summary reports.
5) No signs of infection both by physical exam or by laboratory results
After review of the aforementioned, a licensed physician (Medical Director) determines donor eligibility for birth tissue donation. Once the maternal donor is deemed eligible for birth tissue donation, tissues are aseptically processed and the amniotic fluid undergoes a proprietary sterile filtration process retaining all of the important cytokines, chemokines, growth factors and hyaluronic acid while meeting USP <71> guidelines for sterility. The amniotic fluid is packaged, labeled tested and released into finished goods inventory for distribution.
Studies show that these important proteins in amniotic fluid are host defense in nature and known to reduce inflammation, recruit cells and proteins from surrounding normal tissues (Pierce, et. al.). In addition, research shows that amniotic fluid has anti-microbial factors (Mao et. al.)