Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective:To study the effects of cathepsin K(CTSK)on the healing process of tooth extraction socket and type H blood vessel angiogenesis in mice.Methods:Ctsk knockout(Ctsk-/-)mice were generated by CRISPR/Cas9 technology,and genotype sequen-cing,general observation,Micro-CT and immunohistochemistry were performed to confirm successful knockout of Ctsk.Then 8 week-old WT and Ctsk-/-mice were used to establish the tooth extraction modle by extracting the left maxillary first molars,and the mice were sac-rificed at the day 7,10,14,21,28 and 35 respectively(n=3)after tooth extraction.Then samples were subjected to stereo microscope and Micro-CT examination.Immunofluorescence staining was used to study the effect of Ctsk knockout on type H blood vessel angiogene-sis.Results:Ctsk knockout did not affect the soft tissue healing of tooth extraction socket,but significantly promoted the bone healing process,and Ctsk deficency significantly enhanced type H blood vessel angiogenesis in the tooth extraction socket.Conclusion:Ctsk knockout can enhance type H vessel angiogenesis,and promote bone healing process of tooth extraction socket in mice.

Fifteen patients with Crohn′s disease (CD) in remission diagnosed at Shanghai Jing′an District Central Hospital from February 2018 to June 2019, and 26 matched healthy subjects were recruited. All participants underwent resting-state functional magnetic resonance imaging (fMRI) scans of hippocampus. The amplitude of low-frequency fluctuations (ALFF) was calculated to determine differences in the brain. Left hippocampus was selected as seeds for functional connectivity (FC) analysis, and the results were compared between two groups. The relationship between disease duration and ALFF/FC values in abnormal regions were analyzed with Pearson correlation. Compared with the controls, the ALFF of the left hippocampus (voxel size 32) of CD patients decreased [family-wise error correstion(FWE correction), cluster level P<0.05], and the ALFF of the left medial superior frontal gyrus (voxel size 126), left supplementary motor area (voxel size 126) and left anterior cingulate gyrus increased (voxel size 37) (FWE corrected, cluster level P<0.05). Using the left hippocampus as the seed point for the whole brain functional connectivity analysis, CD patients showed increased FC strength with the left superior temporal gyrus, left medial superior frontal gyrus, left inferior frontal gyrus (opercular part), and right supplementary motor area(FEW corrected, cluster level P<0.05). Correlation analysis did not show a significantly differences between ALFF/FC value of altered brain areas and the disease duration. It suggests that there are changes in spontaneous activities and functional connectivity in the left hippocampus in patients with CD.

A novel hydrophobic ferrocene polymer ( P-Fc) was synthesized successfully. Taken the advantage of 2-hydroxypropyl-β-cyclodextrin ( HP-β-CD ) with hydrophilic outside and hydrophobic inside, P-Fc was successfully enveloped in the cavity of HP-β-CD to form macromolecular vesicle by a self-assembly process. The structure and morphology of the macromolecular vesicle was characterized by FTIR, 1HNMR, SEM and CV. Rhodamine 6G (R6G) and doxorubicin hydrochloride (DOX) was used as target drugs and loaded in the vesicles successfully. After added the oxidant, ferrocene was oxidized to dicyclopentadienyl iron, which destroyed the vesicles successfully. The rapid directional release of the drugs was realized. The maximum loading values of R6G and DOX were 6. 89 and 39. 06 μg/mg, respectively. The release rates were 73. 7%and 88. 2%, respectively. It would increase the utilization level of the drugs and enhance their efficiency.