CxGELSIX: a novel preparation of type VI collagen with possible use as a biomaterial.
OBJECTIVE
This study was initiated to evaluate tissue acceptance and stability of a novel type VI collagen preparation (CxGelsix) as a biomaterial in the rabbit corneal stroma. We hypothesized that CxGelsix, embedded intrastromally, does not have any adverse affect on surrounding corneal tissues, and remains intact in the presence of an acute inflammatory reaction during corneal wound healing.


METHODS
Type VI collagen was extracted and purified from rabbit corneal stroma under nondenaturing conditions. This preparation, Gelsix, was concentrated and cross-linked with polyethylene glycol to produce a transparent film (CxGelsix). Discs of CxGelsix, 4.0-mm diameter, 9- to 35-microm thick were implanted intrastromally and clinically examined periodically for 4 months. In another experiment, implantation of CxGelsix, 2.0-mm-diameter, was followed by corneal wounding adjacent to the implant and examined clinically for 30 weeks. At the end of these periods, the tissues from these experiments were processed for light and transmission electron microscopy.


RESULTS
An intralamellar 4.0-mm-diameter disc of CxGelsix does not alter the structure of corneal epithelium above the implant, suggesting normal transport of nutrients through CxGelsix. Moreover, no structural abnormalities were seen in the rest of the cornea, and the cornea remains transparent. Although the cornea accepts the presence of CxGelsix disc as judged by clinical criteria, gradual degradation of the implant is seen ultrastructurally. CxGelsix is remarkably stable despite its exposure to endogenous enzymes during inflammation and wound healing. Partial degradation of the implant occurs only after many months, and it is gradually replaced with bundles of fine collagen fibrils reminiscent of normal cornea.


CONCLUSIONS
The results of this study suggest that CxGelsix is potentially useful as a biomaterial.
Lekskul
M
M
Schepens Eye Research Institute, and Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA.
Burrows
R
R
Kublin
C L
CL
Cintron
C
C
D000818:Animals; D001672:Biocompatible Materials; D003094:Collagen; D003319:Corneal Stroma / Q000601:surgery* / Q000648:ultrastructure; D003432:Cross-Linking Reagents; D019573:Epithelium, Corneal / Q000473:pathology; D011092:Polyethylene Glycols; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D011817:Rabbits; D014945:Wound Healing
D001672:Biocompatible Materials; D003432:Cross-Linking Reagents; D011092:Polyethylene Glycols; D003094:Collagen