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A team of surgeons and material scientists working at John Hopkins Hospital have made an innovative advancement in treating soft tissue loss. They have engineered a synthetic soft tissue substitute that encourages the growth of the body’s own soft tissue, and is easily tolerated by the body. Unlike other soft tissue substitutes, this material is able to hold its shape.
“As a plastic surgeon, I see patients every day who lose soft tissue like skin, fat and muscle from cancer surgery, trauma or other conditions. Currently our options are limited to implants, which are plagued by fibrosis and other problems, or ‘borrowing’ tissues from elsewhere in the body, which can cause deformity there as well,” says Sashank Reddy, M.D., Ph.D., an instructor in plastic and reconstructive surgery at the Johns Hopkins University School of Medicine and the medical director for Johns Hopkins Technology Ventures.
The research team started by examining the structure of fat cells, both animal and human. Once they had the viscosity and structure of the fat, they experimented with man-made materials, such as hydrogel derived from hyaluronic acid. Hyaluronic acid is used in over 90% of cosmetic fillers in the U.S., and as it already occurs naturally in the human body, utilizing this material in soft tissue repair was a logical choice. After experimenting with hyaluronic acid, the scientists added polycaprolactone (PCL) fibers, which is used in resorbable stitches, in order to make the material retain its structure.
“Nature abhors a vacuum, and soft tissue defects can contract, deform and fill in with scar. In order to reconstruct these defects, we often move fat from one part of the body to another with a process called fat grafting. This is not always successful, as typically half of the grafted fat will die after it’s transplanted, and it’s often hard to predict how well these procedures will work out,” says Justin Sacks, M.D., M.B.A., vice chair of clinical operations and an associate professor of plastic and reconstructive surgery at the Johns Hopkins University School of Medicine.
To test the utility of this new material, the researchers and scientists inserted the material into rabbit tissue, and the results showed great results, with improved tissue in-growth into the composite material. The team hopes to test this composite in patients with soft tissue deficits within a year.
According to extensive research conducted by iData Research, the second largest segment in U.S. soft tissue and reinforcement market is the soft tissue repair market, which is valued at over $675 million and represented over a quarter of the total soft tissue market. Although the skin repair market was negatively affected by reimbursement changes in the past few years, the market value is still expected to increase to just over $1 billion by the end of the forecast period. One of the market drivers for this market is an increase in the types of users. Skin substitutes may be indicated for use on burns or other chronic wounds, including venous leg ulcers and diabetic ulcers. Individuals at risk of developing chronic wounds are the elderly, those with chronic venous disease, diabetics and those who develop ulcers on tissue over bony prominences as a result of extended immobility. Wounds in patients with compromised circulation take longer to heal. This increases the number of potential patients from the low thousands to millions. This new composite from John Hopkins Hospital has been engineered through an extensive trial-and-error method and should be a good entrant to the current market, pending positive human trial results.
“This was an interesting problem to tackle from an engineering point of view,” says Hai-Quan Mao, Ph.D., a professor of materials science and engineering at the Whiting School of Engineering and biomedical engineering at the Johns Hopkins University School of Medicine and the associate director of the Institute for NanoBioTechnology at Johns Hopkins. “Typically a gel-like material that’s porous enough for cells to spread inside is too soft to be able to hold its shape, and a material that is able to retain its shape when placed in the soft tissue defects is conversely too dense for cells to grow into. We really needed to synthesize a new material that is soft and porous yet resilient — almost like fat tissue or Jell-O.”
For Further Information
More on the markets for soft tissue repair can be found in the 2017 edition report published by iData entitled Soft Tissue Repair Market, and covers the U.S., Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. It includes sub-segments by country, and detailed market and unit share analysis.