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Amniotic Regenerative Injections

Amniotic tissue has been used for over 100 years to assist in healing burns and chronic wounds. Recently amniotic injections have been used in orthopedics. The literature on amniotic injections in orthopedics is limited, but in one study has been shown to be beneficial in plantar fasciitis.

The amniotic tissue contains no living cells, but does contain growth factors similar to platelet-rich plasma (PRP) injections. In addition, amniotic products have extracellular matrix components that promote a healing environment.

HOW ARE AMNIOTIC PRODUCTS MADE?

Amniotic products are made from tissue that is discarded after the delivery of a baby, including the amniotic sac and amniotic fluid. The amniotic sac is a portion of the placenta that helps the baby grow. This tissue contains a high concentration of growth factors.

Amniotic tissue is often discarded after childbirth, and harvesting the amniotic tissue poses no risk to the baby or mother. The tissue is processed, sterilized and then either frozen or dried.

WHAT TYPE OF CONDITIONS ARE TREATED?

Most studies to date have focused on amniotic membrane injections in plantar fasciitis. In these studies, amniotic injections have been shown to be beneficial.

  • Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis: a feasibility study. Foot Ankle Int. 2013;34(10):1332-1339.
  • Hanselman AE, Tidwell JE, Santrock RD. Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study. Foot Ankle Int. 2015;36(2):151-158

HOW DO THESE PRODUCTS WORK?

Amniotic tissue is non-immunogenic and has been purified to eliminate risk of the body rejecting the tissue.

Amniotic membrane injections include growth factors. When injected into an injured area, they modulate inflammation, decrease scar tissue formation, and enhance healing. Amniotic products are NOT stem cells.

AVAILABLE AMNIOTIC INJECTIONS

Amniotic membrane injections are commercially available in several forms. Typically, the injections fall into two categories:

  1. Amniotic Membrane Allografts: This version is a purified, micronized dried particulate powder of amniotic tissue growth factors mixed with normal saline prior to injection. It is commonly used for chronic tendon and ligament injuries.
  2. Amniotic Fluid Allografts: These injections are a liquid form of the product obtained from placental fluid at the time of delivery. The amniotic fluid allografts are mainly used in joints because they contain naturally occurring hyaluronic acid in addition to growth factors.

FDA CLASSIFICATION?

Amniotic injections are classified by the US Food and Drug Administration (FDA) as an allograph. This means that the tissue is transplanted from one person to another.

The tissue is from the inner most layer of the amniotic sac that surrounds the developing fetus. The tissue is not a stem cell product and does not contain viable cells.

HOW DO YOU KNOW WHERE TO PLACE THE CELLS?

It is always important to know how the injection is performed. If the clinic is not using imaging to guide the injection, they are injecting blindly and the amniotic tissue may not make it to its intended location.

At BSB/OCPN, we use musculoskeletal ultrasound to identify the injured tendon, ligament or joint and to guide the needle at the injection site. This way we can ensure the growth factors will placed in the exact location of pain.

ARE AMNIOTIC MEMBRANE PROCEDURES COVERED BY INSURANCE?

Although they are FDA-approved, amniotic membrane allografts are still deemed experimental by most insurance carriers and are not covered. Our billing department can answer questions regarding cost.