New Amniotic Allograft Storage Breakthrough Enriches Healing Potential

Advanced stem cell preservation is giving researchers and physicians multiple options.

authors Steve Spencer

Each day, physicians discover more about the power of regenerative medicine, a game-changing specialty that uses biologics to regenerate human cells or tissues to help heal damaged organs.                                                                                                        

One biologic solution that is effective for wound and tissue healing is an amniotic allograft. In this case, a woman having a C-section can donate her placenta from which the amniotic membrane is derived.

The amniotic membrane is rich in stem cells, proteins, and growth factors that are important to healing.

In order for the amniotic allograft to be most effective, it is important to keep as many cells alive as possible between the time the membrane is harvested and stored until it is used with a patient.

Unfortunately, this has been a challenge. For example, in the most common storage technique, where the amniotic membrane is dried and dehydrated, once the water is removed, the structure of the tissue collapses. And while the healing proteins are retained, the stem cells, which create the proteins, die. This means that there will be no new proteins created.

Some providers have tried to freeze the amniotic allograft for storage, but the results are largely the same as with the dehydrated products.

However, recently Birmingham-based Nutech Medical has made a breakthrough in storage technology that appears to boost the allograft’s healing potential.

“Over years of experimentation, we’ve developed a proprietary storage system,” said Howard Walthall, CEO of Nutech. “We store the fresh amniotic membrane in a special solution that maintains the structural integrity and viability for 42 days from the date of processing. This is longer than ever before possible.”

In this fresh amniotic allograft, which Nutech has named Affinity, most of the stem cells are still alive. According to Walthall, the definition of a stem cell is subject to interpretation. “The most common definition of a stem cell is that it can reproduce itself and differentiate down multiple lineages, meaning that it can be persuaded to become a different cell type. Many cells in the body can only become the type of cell they are. A stem cell can, in theory, become a muscle cell, a bone cell or other types, depending on the environment. If that’s the definition of stem cells, then many of the cells in amniotic membrane are stem cells.”

And while stem cells are found everywhere in the body, amniotic based cells have some special traits. “They are much younger so their capacity to reproduce themselves is larger and they can also differentiate into a larger variety of cell types. So they can become almost any cell in the body,” said Katie Mowry, of Research and Development at Nutech.

“Specifically for Affinity,” Walthall said, “these (stem) cells produce proteins in a variety of categories. They produce regenerative proteins, growth factors that play a role in blood vessel formation which is important to bring nutrients to a wound site. They produce anti-inflammatory growth factors and regenerative healing factors. There are many proteins that are produced – probably hundreds. We’ve studied 40 to 50 specifically and we’ve found a large number of growth factors compared to other amniotic products.”

“Growth factors are produced by (stem) cells and usually have an effect on either cell growth or migration,” Mowry said. “For example, a cell in our Affinity Allograft may produce a growth factor that causes the fibroblast cell to do something – maybe to proliferate or move (migrate) to fill in a wound void.

“We haven’t tried to quantify the number of growth factors in Affinity because it’s a tissue product. It’s a whole tissue system. So not only are most of the (stem) cells still alive, but the structure of the matrix remains intact.”

So far, the Affinity allograft has been used by wound care specialists for hard-to-heal wounds as well as by surgeons to close surgical incisions. And orthopedists are using it to heal soft tissue injuries in tendons, ligaments, and cartridge.

“One of the most rewarding experiences with Affinity so far involved a doctor in Pennsylvania who used it on a wound patient,” Walthall said.

“The lady had the wound for two years before she tried Affinity,” Mowry said. “She had been treated before with Debridement, Enzymatic Debridement, and some other graft products. They had also tried using a Wound V.A.C. on it. She was getting close to needing an amputation. She had had osteomyelitis, which is a bone infection, twice because this was such a deep wound. So he started treatment. The physician placed the graft over the wound, and then placed a non-adhesive dressing over the top. He continued this treatment weekly and after six applications, the wound was gone.”

Healing cases like this are becoming more prevalent as advances like the Affinity allograft continue in regenerative medicine.


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