Growth Factor From Purified Amniotic Fluid Treatments - FAQ
What are Purified Amniotic Fluid?
Purified Amniotic Fluid is small, membrane bound extracellular vesicles (EVs) which are released by the developing fetus, placenta, and mother into the amniotic fluid. In simplified terms, they are the fluid of new life.
How are Purified Amniotic Fluid sourced?
The extracellular vesicles are harvested from the amniotic fluid during a full- term, healthy Caesarean birth. In standard practice, a small amount of amniotic fluid is drawn and tested for disease.
With the qualified mother’s consent, NEOBIOSIS contracts with an AATB-accredited third-party birth tissue collection company to harvest and test a larger amount of amniotic fluid, which would otherwise be wasted.
How are Purified Amniotic Fluid produced?
Purified Amniotic Fluid is produced using a proprietary process according to the standards established by the American Association of Tissue Banks (AATB) and in compliance with FDA regulations. Each donor is screened, qualified and consented. Each lot is derived from full-term, healthy pregnancies, tested for sterility and qualified by a third party, independent laboratory.
Aren’t all amniotic tissue products the same?
Amniotic tissue products range greatly in terms of source material, quality of manufacturing, sterilization technique, particle size, protein, RNA, concentration and potential risk of fungal and bacterial infections.
What do Purified Amniotic Fluid contain?
Purified Amniotic Fluid contains RNA, microRNA, proteins and a variety of growth factors. Combined, these can facilitate tissue regeneration and angiogenesis. They regulate inflammation, limit microbial growth and provide immune modulation, all of which are essential components of the healing process.
How many particles does Purified Amniotic Fluid contain?
Each 1 cc vial of Purified Amniotic Fluid contains an average of 250 billion (+/– 100 billion) particles.
Does particle size matter?
Yes, each lot of Purified Amniotic Fluid contains particles between 50 and 150 microns.
When an EV product is comprised of particles of 200 microns or larger it contains other EVs, like apoptotic bodies, which may inhibit the regenerative process. Cloudy amniotic products contain substantial apoptotic bodies as well as other material like vernix. It is not possible to sterile filter these products so many are UV sterilized, which destroys RNA.
Is Purified Amniotic Fluid concentrated or diluted?
No, Purified Amniotic Fluid is produced using “nature’s ratio”. We don’t dilute or concentrate.
How is Purified Amniotic Fluid filtered and sterilized?
Purified Amniotic Fluid is double sterile filtered. Sterility and endotoxin is verified by an independent, third party laboratory.
Is Purified Amniotic Fluid safe?
Purified Amniotic Fluid has been administered to thousands of patients by physicians without any adverse event being reported.