Polymers Coated with Human Extracellular Matrix Improve Device Biocompatibility

While biomechanically suitable for cardiovascular, urological, and hernia repair applications, many polymers fail because of the body's inflammatory and thrombogenic response. But now HIstogen Inc. (San Diego) Pre-clinical research on the insoluble, embryonic-like hECM produced through Histogen's unique manufacturing process has shown the capability of the material to significantly reduce these negative responses, and improve the performance of medical devices.Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present findings today at the American Society for Artificial Internal Organs (ASAIO) Annual Conference. Assessment of bioengineered, human extracellular matrix (hECM)-coated polymers showed a statistically significant reduction in immune cell infiltration, foreign body giant cell formation (p<0.05) and fibrous capsule formation (p<0.001), in addition to improved cell binding and proliferation, representing the potential for this hECM to significantly enhance the biocompatibility of various medical devices.

"Device implants represent an important and expanding multi-billion dollar market and have had a major impact on patient care," said Dr. Gail Naughton, CEO and Chairman of the Board at Histogen. "Problems such as fibrous capsule formation, poor tissue ingrowth, and neointimal hyperplasia resulting from suboptimal biocompatibility must be addressed to offer improved patient benefits. We are encouraged by the results with our embryonic-like matrix, which demonstrate its potential for reducing the foreign body reaction, as well as improving and prolonging the life and function of implantable devices."

Testing, which was performed as part of a partnership with the National Research Council's Advanced Materials Division, involved coating of several commonly utilized device materials, including nylon, polypropylene (PPE), and polyethylene terephthalate (PET) nonwoven scaffolds with hECM using several common coating methods. The hECM-coated and uncoated scaffolds were then surgically implanted in the subcutaneous space of SCID mice and histological samples of excised implants were assessed for inflammatory response, cellular infiltration, foreign body giant cells and capsule formation.

"Coating polymers with a naturally-produced, all-human ECM masks the foreign device material and offers a physiological surface which supports healthy tissue infiltration and interaction," said Dr. Michael Zimber, Director of Applied Research at Histogen. "The hECM-coated polymers promoted a two-fold increase in normal cell proliferation as compared to uncoated polymers, as well as causing a significant reduction in the host inflammatory and fibrotic response to surgically implanted polymers."