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Rat-Tested PEG-HA Soft Tissue Implant Feasible in Humans

Last Updated: August 10, 2011.

A biosynthetic soft-tissue replacement composed of polyethylene glycol photocrosslinked with hyaluronic acid tested on rats is feasible in humans, without serious adverse events, according to a study published online July 27 in Science Translational Medicine.

WEDNESDAY, Aug. 10 (HealthDay News) -- A biosynthetic soft-tissue replacement composed of polyethylene glycol (PEG) photocrosslinked with hyaluronic acid (HA) tested on rats, is feasible in humans, without serious adverse events, according to a study published online July 27 in Science Translational Medicine.

Alexander T. Hillel, M.D., from the Johns Hopkins University in Baltimore, and colleagues attempted to design and optimize a flexible, biosynthetic, soft-tissue replacement system with customizable viscoelastic properties, controllable residence time in vivo, and compatible with HA formulation. PEG was crosslinked with HA, and injected and photocrosslinked in situ to create a semipermanent implant. Different concentrations of PEG and HA were injected in the dorsal subcutaneous space of rats, exposed to a green light-emitting diode, and monitored over time using magnetic resonance imaging. The safety and efficacy of two photocrosslinked PEG-HA were compared to two commercial HA implants by injecting them in the intradermal and subcutaneous space of three patients 12 weeks before scheduled abdominoplasty surgery.

The investigators identified a dose-dependent relationship between increasing PEG concentration and implant volume persistence in rats implanted with photocrosslinked PEG-HA. Compared with a commercial HA injection, PEG-HA implants maintained significantly greater average volumes and heights, which could be reversed with hyaluronidase injection. Neither photocrosslinked PEG-HA nor commercial HA preparations showed any serious adverse events in humans. Mild transient erythema and sensation of heat and pain was experiencing during the light exposure for photocrosslinking of PEG-HA. These sensations resolved within 12 hours of crosslinking. An inflammatory response was seen surrounding some of the materials.

"Our results present a photocrosslinkable biosynthetic material that might be customized to manipulate elasticity, persistence, and reversibility, resulting in multiple applications," the authors write.

Two authors are inventors on intellectual property owned by Johns Hopkins University covering light-activated HA biomaterials. One author disclosed financial ties to Kythera Biopharmaceuticals, which funded the study.

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