Porcine small intestinal submucosa (SIS) has been recommended as a cell-free, biocompatible biomaterial for the repair of rotator cuff tendon tear. However, we have observed noninfectious edema and severe pain in patients who have undergone SIS implantation for tendon repair. The aim of this study was to conduct an independent assessment of the safety and efficacy of Restore SIS membrane. The Restore orthobiologic implant was examined by histology and the nested PCR technique using porcine immunoreceptor DAP12 gene to examine if SIS membrane contained porcine cells or DNA, respectively. The material was also implanted into mice and rabbits for the evaluation of biological reaction and inflammatory response. Restore SIS was found to contain multiple layers of porcine cells. Chloroacetate esterase staining showed that some of these cells were mast cells. Nested PCR of the DAP12 gene demonstrated that Restore SIS contained porcine DNA material. Subcutaneous implantation of Restore SIS membrane in mice, and in rabbits for rotator cuff tendon repair, showed that the membrane caused an inflammatory reaction characterized by massive lymphocyte infiltration. In conclusion, Restore SIS is not an acellular collagenous matrix, and contains porcine DNA. Our results contradict the current view that Restore SIS is a cell-free biomaterial, and that no inflammatory response is elicited by its implantation. We suggest that further studies should be conducted to evaluate the clinical safety and efficacy of SIS implant biomaterials.
Mice fed a high cholesterol-cholic acid diet for two to six months develop gallstones; these were studied by transmission electron microscopy after glutaraldehyde-digitonin fixation. Examination of the contents of mouse gallbladders presents views of layered structures and surrounding amorphous material. We interpret these images of gallstones to suggest that they may arise by cohesion of material rich in cholesterol to form more ordered structures. Gallbladder contents of mice fed the diet for five to six months were found to contain occasional crystals and rectangular areas similar to those observed in thin sections of human gallstones (unpublished observations). Recent findings that human gallstones can be dissolved with chenodeoxycholic acid are discussed, with reference to their applicability to studies of gallstones in mice.
We report the results of the first joint observation of the KAGRA detector with GEO600. KAGRA is a cryogenic and underground gravitational-wave detector consisting of a laser interferometer with three-kilometer arms, and located in Kamioka, Gifu, Japan. GEO600 is a British–German laser interferometer with 600m arms, and located near Hannover, Germany. GEO600 and KAGRA performed a joint observing run from April 7 to 20, 2020. We present the results of the joint analysis of the GEO–KAGRA data for transient gravitational-wave signals, including the coalescence of neutron-star binaries and generic unmodeled transients. We also perform dedicated searches for binary coalescence signals and generic transients associated with gamma-ray burst events observed during the joint run. No gravitational-wave events were identified. We evaluate the minimum detectable amplitude for various types of transient signals and the spacetime volume for which the network is sensitive to binary neutron-star coalescences. We also place lower limits on the distances to the gamma-ray bursts analysed based on the non-detection of an associated gravitational-wave signal for several signal models, including binary coalescences. These analyses demonstrate the feasibility and utility of KAGRA as a member of the global gravitational-wave detector network.
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