Amnion and Amniotic Fluid
CellReGen™ collects Amniotic Membrane (AM) and Amniotic Fluid (AF) from eligible donors. These birth tissues can be used to promote healing and prevent scarring and infection in a number of scenarios, including:
- Wound Healing
- Various Surgeries
Amniotic Membrane and Amniotic Fluid manufactured by CellReGenTM 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. CellReGenTM amniotic membrane is sterile and used as a protective covering to treat a variety of applications.
CellReGenTM amniotic fluid is sterile, acellular and contains human proteins, hyaluronic acid, cytokines and chemokines which are known to promote healing and protect human cells and tissues.
The University of Utah CellReGenTM 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. CellReGenTM has a Medical Director who 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. CellReGenTM is registered with the FDA and is an American Association of Tissue Banks accredited facility for the manufacturing and distribution of these birth tissues.