Stem Cell Therapy Face
Stem cell therapy is a completely natural, injection based treatment which is designed to stimulate the body’s regenerative abilities. Prior to treatment, a stem cell banks living stem cells are harvested and concentrated into an injectable serum. In many cases other blood cells or cell-like particles, i.e. Hyaloronic acid, exosomes or platelets, are included into the mix. Once introduced into damaged tissue a powerful, localized healing response results. In this way chronically damaged structures can be made to heal properly and completely.
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Postnatal Stem Cells and FDA Regulations
[caption id="attachment_2195" align="alignleft" width="300"] Platelet-Rich plasma preparation. Plasma in syringe. Centrifuge. Background[/caption]
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.
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:
- 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 NAT (Ultrio)
- WNV NAT
Processing this proprietary process meets the FDA’s requirements being minimally manipulated, include:
- For structural tissue, processing that does not alter the original relevant characteristics of the tissue related to the tissue’s utility for reconstruction, repair or replacement; and
- For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
- 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.