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Postnatal Stem Cells and FDA Regulations

Recently, there have been several nationally published articles concerning the use of postnatal stem cells and the governing regulations of the FDA. The FDA has acknowledged that stem cell products have the potential to treat many medical conditions and diseases and have strict regulatory restrictions in place and often review manufacturers processes and procedures for compliance. 

As part of the FDA’s review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the product’s safety, purity, and strength (potency).

We are proud of our 14-year history of remaining compliant without any violations issued. 

Through our strict processes, we take every precaution available to ensure that our products are safe, in their purest form and maintain the highest quality of potency.

Eligibilty

Our proprietary process begins with a meticulous screening of the donor mother and father as well as family members for several generations.

Collection

The Director of Procurement will notify the Recovery Specialist that a donation is ready at the designated hospital. The Recovery Specialist will collect the donation and return it directly back to Utah Cord Bank to be processed.

Testing

Our lots are quarantined for 14 days and thoroughly tested for bacterial and disease contamination by a CLIA certified lab.

Processing

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

UTAH CORD BANK EMPHASIZES A 100% Chain of Custody

Collection of Postnatal Donation A Recovery Specialist, once given the donation information from the Director of Procurement, will collect the postnatal donation at the designated hospital. The Recovery Specialist will then return the donation to UCB to be processed. 

Donor Eligibility Requirement Our proprietary process begins with meticulous screening of the donor mother and father as well as family members for several generations. In addition to routine industry screens for blood borne pathogens, we 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. Postnatal tissues can be collected within 30 minutes of a Cesarean section. After processing, allografts are tested again to ensure they are free of contaminants or infection, and contain healthy, viable cells prior to cryopreservation. 

Testing Procedures Include:

  • Communicable disease testing performed by a CLIA certified lab.
  • Before the release and distribution of any product, our lots are quarantined for 14 days and thoroughly tested for bacterial contamination.
  • Plate testing is conducted in multiple phases of the production process to ensure there is zero contamination.

Diseases that are tested prior to donation eligibility:

  1. Hepatitis Bs Ag
  2. Hepatitis Bc Ab
  3. HTLV I/II Ab
  4. Hepatitis C Ab
  5. HIV 1&2 Plus O Ab
  6. CMV ab
  7. RPR (Non-treponemal syphilis)
  8. HIV-1/HCV/HBV NAT (Ultrio)
  9. WNV NAT

Our proprietary process meets the FDA’s requirements of being minimally manipulated, and include(s):

  1. For structural tissue-processing, does not alter the original relevant characteristics of the tissue related to the tissue’s utility for reconstruction, repair or replacement.
  2. For cells or nonstructural tissues, processing does not alter the relevant biological characteristics of cells or tissues.
  3. Transfer means the placement of human reproductive cells or tissues into a human recipient.

Cryopreservation: We use a unique cryopreservation technique that includes using the donation’s own natural components integrated with a natural cryoprotectant to help ensure maximum functional cells post-thaw for homologous use.

Shipping: Our products are shipped overnight in cryopreserved authorized shipping containers. Products are shipped only to licensed medical professionals.