Amnion and Amniotic Fluid
The CTRM consents women planning cesarean delivers to donate birth tissues, Amniontic Membrane (AM) and Amniotic Fluid (AF), which are normally discarded following surgery. These birth tissues can be used to promote healing and prevent scarring and infection in a number of scenarios, including:
- Would Healing
- Various Surgeries
Amnion Membrane and Amniotic Fluid manufactured by the Cell Therapy and Regenerative Medicine facility are classified and qualify as a human tissue allograft (HCT/P) as outlined in 21CFR 1271 under Section 361 of the Public Health Service Act. Both AM and AF meet the requirements for “Homologous Use” as they are used to cover and protect tissues.
AM is secondarily sterilized and AF is sterile filtered and tested under USP <71> guidelines. Sterile-filtered AF has no live cells, cell debris, hair, vernix or other debris. Sterile-filtered AF contains human proteins, hyaluronic acid, cytokines and chemokines which are known to promote healing and protect human cells and tissues.
The University of Utah Cell Therapy and Regenerative Medicine screens birth tissue donors for infectious diseases through medical and social history questionnaire, medical record review, and testing of the donor’s blood for viruses including HIV, Hepatitis B & C, and others. The Cell Therapy and Regenerative Medicine’s Medical Director evaluates these records and test results to determine if the donor meets eligibility requirements.
Although the risk of transmitting infectious disease is very minimal, there is a potential for transmission.The CTRM is an American Association of Tissue Banks accredited facility for the manufacturing and distribution of these birth tissues.