Breast conserving surgery, otherwise known as lumpectomy, is performed on nearly 1.3 million breast cancer patients globally, each year. Complete removal of cancerous tissue and preservation of the breast’s shape, appearance, and consistency are central to the patient’s quality of life, post-surgery.

It is extremely challenging for surgeons to predict the cosmetic outcome of such surgeries given variations in tumor size, shape and location, the unpredictable nature of the tissue repair process, and effects of additional therapy. Currently there are no commercial products that allow surgeons to predictably restore, reconstruct, or regenerate soft tissues, such as the breast.

To address this gap scientists have developed a new polymer technology that will improve tissue restoration outcomes for people with breast cancer and other diseases or traumatic injuries that require reconstruction surgery of soft tissues.

Researchers at Purdue University, along with breast surgeon Carla Fisher, MD, of Indiana University School of Medicine, teamed up with the Purdue startup GeniPhys to develop and perform preclinical studies on a regenerative tissue filler.

This is a first-of-a-kind, scaffold-forming collagen that acts as a tissue-filler at the location of the lesion. When inserted into soft tissue defects and voids, it shows promise in accelerating and improving tissue restoration outcomes. The team’s work is published in Scientific Reports in the article titled, “Regenerative tissue filler for breast conserving surgery and other soft tissue restoration and reconstruction needs.”

“It would assist in maintaining the quality of life and emotional well-being of millions of breast cancer survivors each year worldwide,” says Sherry Harbin, PhD, professor in Purdue’s Weldon School of Biomedical Engineering.

Innovators in Harbin’s lab have designed and patented the collagen polymer used for this technology and Harbin has founded GeniPhys, a Purdue startup focused on the commercialization of this collagen polymer.

“Such an approach may also benefit other patient populations in need of soft tissue restoration or reconstruction, including children with congenital defects, individuals with difficult-to-heal skin ulcers, individuals suffering from traumatic injuries and cancer patients requiring resection of tumors within tissues other than breast,” says Harbin.

The collagen polymer not only acts as a tissue filler but also promotes regeneration. When applied to breast tissue voids, such as those associated with breast conserving surgery, the polymer restores breast shape and consistency and supports new breast tissue formation over time, including different tissue components such as mammary glands, ducts and adipose tissue. The filler also helps avoid wound contraction and scar formation, which can be painful for patients and contributes to breast deformities.

“This tissue filler represents the first planned medical product developed using our innovative collagen polymer technology,” says Harbin. “This collagen polymer supports custom fabrication of a broad range of collagen materials for various applications including tissue restoration, therapeutic cell and drug delivery, or enhancement of tissue-implantable devices interfaces.”

This filler consists of a highly purified liquid collagen protein, that when brought to physiologic conditions by mixing with a proprietary buffer, can be applied to tissue voids. The liquid collagen conforms to shape and size of the patient-specific tissue void geometry and then undergoes a self-assembly reaction to form a fibrillar collagen scaffold like those that make up the body’s own tissues.

The collagen polymer scaffold is easy to apply and adopts a soft tissue consistency in time, persisting at the location of the void where it induces a regenerative healing response.

The collagen filler is not negatively impacted by radiation therapy and does not compromise interpretation of diagnostic imaging procedures, the authors note.

The preclinical validation studies performed by the team that included biomedical engineers from Purdue’s Weldon School, Fisher from Indiana University School of Medicine, and Jeannie Plantenga, PhD, and Abigail Cox, PhD, from Purdue’s College of Veterinary Medicine was supported by a National Science Foundation SBIR Phase I award to GeniPhys.

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