The Donor Process

The Labs proprietary process begins with meticulous screening of the donor mother and father as well as family members through several generations.  In addition to routine industry screens for bloodborne pathogens, they 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 as donors with the labs.  These postnatal tissue donations are promptly collected from local hospitals by the lab specialists following a healthy cesarean birth.  After processing takes place in their lab, allografts are tested again to ensure they are free of contaminants or infection, and contain healthy, viable cells prior to cryopreservation.

                 

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We Put Families First

Our providers lots are quarantined for 14 days and thoroughly tested for bacterial, communicable and other disease contamination by a CLIA-certified lab. In addition, plate testing is conducted in multiple phases of their process to ensure zero contamination on all their products.


Diseases that are tested for donation eligibility:

  • Hepatitis Bs Ag

  • Hepatitis Bc Ab

  • HTLV I/II Ab

  • Hepatitis C Ab

  • HIV 1&2 Plus O Ab

  • CMV ab

  • RPR (Non-treponemal syphilis)

  • HIV-1/HCV/HBV

  • Covid-19

How Its done!

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ELIGIBILITY - Meticulous screening of donor mothers and fathers, as well as family members ensures product safety and viability.

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COLLECTION - After the birth our provider has a Recovery Specialist there who collects the postnatal donation at the designated hospital and the returns the donation to their lab to be documented and processed.

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TESTING - All of their lots are quarantined for 14 days and thoroughly tested for bacterial and disease contamination by a CLIA certified lab.

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PROCESSING - Our providers proprietary process meets the FDA’s requirements of cells and tissues being minimally manipulated.

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100% CHAIN OF CUSTODY - With collection of a healthy postnatal donation, they follow complete and proper testing procedures, an FDA minimally manipulated process, and a unique cryopreservation method, so you can be rest assured that our provider manufactures a safe and reliable product with a proven 100% Chain of Custody.