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Ortho-ACI

✓ Approved

Orthocell Pty, Ltd. · 细胞治疗 · 细胞治疗

什么是 Ortho-ACI？

Ortho-ACI 是一种细胞治疗，由Orthocell Pty, Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Surgical Implantation。

药物档案

公司Orthocell Pty, Ltd.
药物类别细胞治疗
给药途径Surgical Implantation
状态Approved
来源： ClinicalTrials.gov, Orthocell Pty, Ltd.

治疗适应症

Ortho-ACI 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Musculoskeletal and connective tissue disordersChondropathy✓ Approved

相关研究文献

PubMedAsian Pacific journal of cancer prevention : APJCP2026-10-27

Association of Abdominal Aortic Calcification with Pathological Response to Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer: A Retrospective Exploratory Study.

Kutlu Özlem Ö, Özenbaş Cemre C, Büyüktoka Raşit Eren RE, Gül Gürkan G et al.

Pathological response to neoadjuvant chemotherapy is an important prognostic determinant in patients with locally advanced gastric cancer (LAGC). However, reliable pretreatment biomarkers for predicting treatment response remain limited. Abdominal aortic calcification (AAC), an imaging marker of systemic atherosclerosis, can be readily assessed on routine computed tomography (CT). This study investigated the association between baseline AAC and pathological response to neoadjuvant chemotherapy in patients with LAGC. This retrospective exploratory study included patients with histologically confirmed LAGC who received neoadjuvant FLOT chemotherapy followed by curative-intent gastrectomy between January 2024 and January 2025. Pretreatment CT images were reviewed to quantify AAC using the abdominal aortic calcification index (ACI). Pathological response was evaluated according to the Mandard tumor regression grade (TRG) system. Receiver operating characteristic (ROC) curve analysis and logistic regression analyses were performed to evaluate the association between ACI and pathological response. A total of 47 patients were included, with a median age of 64 years, and 70.2% were male. Patients with higher ACI values were significantly older than those with lower values. ROC analysis demonstrated limited discriminatory performance of ACI for predicting pathological response. Using an optimal cutoff value of 3.28, the sensitivity and specificity of ACI were 60.0% and 60.4%, respectively. Older age, hyperlipidemia, and clinical T stage were significantly associated with poorer pathological response in univariate analyses. However, ACI was not independently associated with pathological response in multivariable logistic regression analysis. Baseline AAC was not independently associated with pathological response to neoadjuvant chemotherapy in patients with LAGC. AAC may reflect host-related vascular aging rather than tumor-specific treatment sensitivity and may contribute to future exploratory risk-stratification models.

PMID 42935064
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PubMedCartilage2026-10-27

Autologous Chondrocyte Implantation With Knee Osteotomy in Middle-Aged Patients Demonstrates a Chondrogenic Transcriptomic Profile and Favorable Histological Repair.

Iseki Tomoya T, Onishi Shintaro S, Kanto Ryo R, Nakao Yoshitaka Y et al.

ObjectiveThe primary aim was to characterize cartilage repair following autologous chondrocyte implantation (ACI) with knee osteotomy in middle-aged patients, hypothesizing favorable histological repair and a chondrogenic transcriptomic profile. Secondary comparisons with isolated osteotomy were exploratory.DesignThis prospective case series with a nonrandomized comparison group included 12 patients aged 50-65 years with International Cartilage Repair Society (ICRS) grade 3-4 cartilage defects (>4 cm2) and varus malalignment. Six underwent two-stage ACI with osteotomy and six underwent osteotomy alone; allocation followed Japanese insurance indications for ACI. Patient-reported outcomes were assessed preoperatively and at 1 year. Both groups underwent second-look arthroscopy, ICRS II histological assessment, and RNA sequencing. Graft biochemical properties were compared between younger and older cohorts.ResultsThe ACI group had higher macroscopic repair scores (10.3 ± 1.0 versus 6.0 ± 4.4; P = 0.04) and histological scores (median, 75 versus 50; P = 0.03). Lysholm scores improved in both groups (both P = 0.031); KOOS, IKDC, and VAS changes were not significant. No between-group differences in changes from baseline were significant for any patient-reported outcome. COL2A1, ACAN, and COMP expression was higher in the ACI group. Graft sGAG content and cell number did not differ significantly between age groups.ConclusionACI with osteotomy showed favorable histological repair and a chondrogenic transcriptomic profile. The small sample, nonrandomized allocation, and short follow-up make between-group findings exploratory. Larger, longer-term studies are needed to establish clinical significance and durability.

PMID 42937289
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PubMedPolymers2026-10-27

Per-Layer UV Exposure-Dependent Cytotoxicity of 3D-Printed Aligner Resins and Estrogen-like Activity Screening.

Šimunović Luka L, Marić Antun Jakob AJ, Meštrović Senka S

Per-layer UV exposure during 3D printing may influence polymerization and the biological response of photocurable aligner resins. This study evaluated exposure-dependent cytotoxicity of Tera Harz TC-85 and NextDent Ortho Flex and performed an exploratory screening of selected resin-specific printing conditions for ER-selective estrogen-like responses. TC-85 was printed at 2.0, 2.4, 3.0, and 4.0 s per layer, and Ortho Flex at 5.0, 6.0, 7.0, and 8.0 s per layer. The resin-specific per-layer UV exposure ranges were selected based on our previous physicochemical characterization of the same materials and printing system. Extracts were prepared according to ISO 10993-12. Cytotoxicity was assessed in human gingival fibroblasts using the MTT assay, while selected conditions (TC-85, 2.4 s; Ortho Flex, 7.0 s) were evaluated in estrogen receptor (ER)-positive MCF-7 and ER-negative MDA-MB-231 cells as an exploratory screening assay rather than a direct test of ER activation. For both resins, per-layer exposure condition, extract concentration, and their interaction significantly affected the normalized MTT response. At 50% extract concentration, normalized MTT responses ranged from 89.2% to 111.3%, whereas Ortho Flex ranged from 8.8% to 76.8%, with the 8.0 s condition being the only Ortho Flex condition above the 70% cytotoxicity threshold. Ortho Flex showed pronounced cytotoxicity in concentrated extracts, particularly at shorter exposure times, whereas TC-85 showed a less monotonic exposure-dependent pattern. In the exploratory screening, the 6.25% Ortho Flex extract produced a normalized MCF-7 MTT response of 129.1%, but this was comparable with the corresponding saline vehicle response of 137.0% and was not statistically greater than the response in ER-negative MDA-MB-231 cells. No statistically supported ER-selective response was detected for either tested resin under the specific screening conditions; however, exposure-time dependence of this response was not evaluated. Per-layer UV exposure therefore influenced the HGF-1 MTT response in a resin- and concentration-dependent manner. For dental laboratory practice, these findings support the use of resin-specific, validated printing parameters rather than transferring exposure settings between materials; deviations from manufacturer-specified processing conditions should be independently validated before clinical use.

PMID 42942590
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PubMedBiomedicines2026-10-27

Identification of Genes Associated with Gut Microbiota Metabolites in Type 2 Diabetes Mellitus Complicated by Acute Cerebral Infarction Based on Bioinformatics and Mendelian Randomization.

Zhang Guimei G, Ju Jiasheng J, Zhang Run R, Xu Xiuyuan X et al.

Background: Type 2 diabetes mellitus (T2DM) and acute cerebral infarction (ACI) are globally prevalent diseases that impose substantial public health burdens. While gut microbiota (GM) is increasingly recognized to regulate metabolic and immune homeostasis linked to both diseases, its shared genetically predicted microbial taxa and underlying metabolite-gene regulatory mechanisms in T2DM and ACI remain unclear, highlighting the need for systematic investigation. Accordingly, this study aimed to elucidate their regulatory mechanisms. Methods: Transcriptomic datasets, genome-wide association study (GWAS) data, and GM data were retrieved from public databases. Key microbial taxa were identified using two-sample Mendelian randomization (MR) and 16S rRNA sequencing. Metabolite-target genes (MTGs) were predicted via public databases. Key metabolites were screened based on Lipinski's rules and low toxicity, and key genes were prioritized by molecular docking. Regulatory networks and potential drugs were predicted using public databases. Results: Using the FinnGen diabetes endpoint as a proxy for T2DM-related genetic susceptibility, MR analysis identified 12 candidate microbial taxa shared by both diseases. Further intersection with the top 30 microbial taxa from 16S rRNA sequencing confirmed two key microbial taxa (Alistipes and Bifidobacterium). Subsequently, 602 MTGs were identified for metabolites derived from the key microbial taxa. After druggability evaluation and toxicity profiling, nine key metabolites with favorable druggability and low toxicity were identified. Molecular docking predicted binding affinities between these key metabolites and the encoded proteins, suggesting ANPEP and CYP1B1 as candidate key genes. Additionally, ANPEP interacted with 12 transcription factors (TFs), while CYP1B1 was regulated by six TFs and 13 microRNAs that further interacted with 26 long noncoding RNAs. Sixty-eight and 32 potential drugs targeting ANPEP and CYP1B1, respectively, were identified, providing candidates for translational research. Conclusion: This study systematically identified ANPEP and CYP1B1 as candidate key genes in the GM-associated regulatory network underlying T2DM-related genetic susceptibility and ACI, providing candidate molecular targets and candidate compounds for the development of GM-based targeted therapies.

PMID 42940176
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PubMedACS nano2026-10-27

Electronic Structure Modulation in Isomeric Carborane-Thiolated Cu4 Nanoclusters Boosts CO2 Electroreduction to Methane.

Nisar Juhina J, Jana Arijit A, Li Zhengyuan Z, Minhas Harpriya H et al.

Electrochemical CO2 reduction (eCO2R) to energy-dense hydrocarbons is central to sustainable carbon recycling, although achieving selective conversion at high current density and lower overpotential remains challenging. Here, we explore three molecularly precise nanomaterials, comprising nearly square planar Cu4 kernel protected by isomeric carborane-thiolate (CBT) cages, viz., Cu4-oCBT (ortho-carborane), Cu4-mCBT (meta-carborane), and Cu4-ICBT (iodinated-ortho-carborane), for eCO2R. Among them, Cu4-mCBT shows the most favorable performance, achieving ∼74% overall eCO2R selectivity and a CH4 Faradaic efficiency (FE) of ∼45% at high current densities of 500 mA cm-2 (-0.87 V vs RHE) while maintaining promising production of C2+ products. Furthermore, Cu4-mCBT and Cu4-ICBT catalysts deliver industrially relevant CH4 partial current densities (JCH4 ∼ 323 mA cm-2 at -0.99 V) at low overpotential, representing competitive performance compared to Cu nanoclusters (NCs) stabilized by conventional ligands. First-principles calculations reveal that Cu4-mCBT lowers the free energy barrier for *CHO to *CHOH hydrogenation, the rate-limiting step for methane formation, due to better orbital interactions with the intermediates. In situ attenuated total reflectance surface-enhanced infrared absorption spectroscopy (ATR-SEIRAS) confirms the transient intermediate species formed in the predicted eCO2R-to-CH4 pathway. Charge density difference, projected density of states, and in situ X-ray absorption studies demonstrate the primary catalytic role of the Cu-core, while three-dimensional cage-like ligand shells modulate the electronic structure of exposed metal atoms, thereby optimizing the intermediate binding. This study investigates the catalytic performance of carborane-appended tetranuclear copper clusters toward CO2 reduction pathways and elucidates their structure-activity relationships.

PMID 42937565
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PubMedMaterials (Basel, Switzerland)2026-10-27

Combined Use of Sodium Bentonite and Recycled Aggregates in Concrete: Microstructural Characterization and Mechanical Performance.

Morales-Beltrán Hugo H, Gálvez Edelmira E, Salinas-Rodríguez Eleazar E, Saldana Manuel M et al.

The reuse of construction and demolition waste (CDW) and supplementary aluminosilicate materials can reduce the environmental impact of concrete. This study evaluated two formulations produced with fine and coarse recycled CDW aggregates: a control with 0 wt% sodium bentonite and an experimental mixture with 5 wt% sodium bentonite as a partial Portland cement replacement (ACI 211.1-91, target 19.61 MPa at 28 days). Two independent control batches achieved 19.833 MPa (202.24 kg/cm2) and 19.788 MPa (201.78 kg/cm2) (mean 19.810 MPa, 101.01% of target). The 5 wt% bentonite mixture achieved a mean of 15.353 MPa (156.55 kg/cm2, SD 0.060 MPa, CV 0.391%, 95% CI, 15.290-15.416 MPa, n = 6), equivalent to 78.29% of the target strength and 22.50% lower than the control mean. The six specimens containing 5 wt% bentonite were technical replicates obtained from a single batch, whereas control values correspond to two independent batches (one specimen each); therefore, confidence intervals are presented descriptively. Characterization of the 5 wt% formulation at 28 days was performed by XDR, SEM, and EDS. XRD identified calcite, ettringite, quartz, and signals compatible with calcium silicate hydrate (C-S-H) products and tobermorite. SEM reveals a heterogeneous matrix with acicular morphologies compatible with C-S-H and densified regions. EDS showed O 54.8 wt%, Ca 27.8 wt%, Si 10.2 wt%, and Al 2.8 wt% with heterogeneous distribution of Ca, Si, and Al without marked segregation at the observation scale. Characterization was limited to the 5 wt% formulation at 28 days; therefore, observed phases and morphologies cannot be attributed exclusively to bentonite.

PMID 42941018
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