Information for Patients

What is amniotic tissue and fluid?

Amniotic tissue and fluid facilitate fetal growth and provides mechanical cushioning and antimicrobial properties that protect and nourish the fetus.

The amniotic membrane is the innermost layer of the placental membranes. The fresh amniotic membrane contains bioactive factors such as collagen, cell adhesion molecules, stem cells and growth factors that promote the healing process. However, processing of the membrane can only be done according to FDA guides which surprisingly results in the inactivation of the regenerative “stemness” of the cells. THERE ARE NO LIVE STEM CELLS IN AMNIOTIC TISSUE AND FLUID.

Amniotic fluid contains growth factors carbohydrates, lipids, amino acids, enzymes, exosomes and microRNA’s that do the bulk of the regenerative activity.

How do these products work?

These components work together at the site of the injury where the microRNA’s appear to activate the patient’s own stem cells in the tissue, which in turn, differentiate into new cells, and the injured tissue can be regenerated, repaired, and restored back to its normal state.

The amniotic fluid has immunomodulatory activity which appears to markedly silence a variety of inflammatory genes, thereby contributing to tissue healing and pain reduction.

How are these products stored?

Amniotic tissue and fluid products are available as a cryopreserved injectable allograft fluid and as a membrane.

The amniotic fluid is cryopreserved containing tissues that have been frozen at a very low temperature (-80C) to retain its unique structure and biochemistry. Amniotic fluid is kept frozen until it is ready to use.

The amniotic membrane is stored at ambient temperature and contains enriched levels of growth factors, extracellular matrix (ECM), and laminins providing numerous components of tissue regeneration. The membrane is 150-250 microns thin and has been utilized successfully to treat chronic non-healing wounds and as a barrier to protect nerve, tendons and ligaments.

How does the FDA regulate the use of amniotic tissue and fluid?

Amniotic tissue and fluid are “regulated” by the Food and Drug Administration (FDA) under Section 361 of the Public Health Safety Act (PHSA), Code for Federal Regulation (CFR) 1271.3 and 1271.10 as minimally manipulated tissue allograft www.fda.gov (Regulation of Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/P’s)

How long has amniotic tissue and fluid been utilized by the medical community?

Amniotic allografts have been successfully used since the early 1900’s as an alternative modality for treatment for chronic wounds. More recently physicians have used these products to treat ocular surface disorders, chronic non-healing diabetic wounds, Achilles tendinitis, plantar fasciitis, pain management, osteoarthritic conditions, sports injuries, in a variety of surgical procedures, and in treating neuropathic pain.

Amniotic tissue and fluid contain many unique properties that help heal injured tissue, while reducing inflammation and scarring.

Is amniotic tissue and fluid covered by commercial insurance?

Amniotic tissue and fluid is reimbursement eligible contingent on the patient’s plan of coverage.

Is amniotic tissue and fluid covered by Medicare?

There are no exclusionary criteria for the use of amniotic tissue and fluid by Medicare.