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
  • Burns
  • Various Surgeries 

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Manufacturing

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. 

Screening

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.

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Sterile Amniotic Fluid (AF) Allograft

AF100 1.0 mL
AF200 2.0 mL
AF300 3.0 mL

Amniotic Membrane Allograft

Dry
AG0022         2x2 cm2
AG0024         2x4 cm2
AG0044         4x4 cm2
AG0046         4x6 cm2
AG0048         4x8 cm2
Wet
AGW0022     2x2 cm2
AGW0024     2x4 cm2
AGW0044     4x4 cm2
AGW0046     4x6 cm2
AGW0048     4x8 cm2
AGW0715     7x15 cm2