Evaluating CAPO®: A biocompatibility, transparency, and fitment assessment for use with CEREBO® in traumatic intracranial injury detection.

Healthcare-associated infections (HAIs) are a global concern affecting millions of patients, requiring robust infection prevention and control measures. In particular, patients with traumatic brain injury (TBI) are highly susceptible to nosocomial infections, emphasizing the importance of infection control. Non-invasive near infrared spectroscopy (NIRS) device, CEREBO® integrated with a disposable component CAPO® has emerged as a valuable tool for TBI patient triage and this study evaluated the safety and efficacy of this combination. Biocompatibility tests confirmed safety and transparency assessments demonstrated excellent light transmission. Clinical evaluation with 598 enrollments demonstrated high accuracy of CEREBO® in detecting traumatic intracranial hemorrhage. During these evaluations, the cap fitted well and moved smoothly with the probes demonstrating appropriate flexibility. These findings support the efficacy of the CAPO® and CEREBO® combination, potentially improving infection control and enhancing intracranial hemorrhage detection for TBI patient triage. Ultimately, this can lead to better healthcare outcomes and reduced global HAIs.

'Site of contact genotoxicity' assessment for implants - Potential use of single cell gel electrophoresis in biocompatibility testing of medical devices.

Toxicological risk assessment of medical devices requires genotoxicity assessment as per ISO 10993, Part 3, which is designed to address gene mutations, clastogenicity and/or aneugenicity endpoints. 'Site of contact genotoxicity' is a potential genotoxic risk especially for medical implants, that is currently not addressed in biocompatibility standards. We therefore performed initial validation study on the use of alkaline single cell gel electrophoresis (comet assay) for detecting 'site of contact genotoxicity' of medical devices, using test items made of acrylic implants impregnated with ethyl methanesulphonate (EMS). Comet assay detected increased DNA migration at the site of implantation, but not in the liver. The same implants also failed to show any genotoxicity potentials, when tested on the standard test battery using Salmonella/microsome and chromosome aberration assays. The study suggested that some medical implants can cause 'site of contact genotoxicity', without producing systemic genotoxicity. In conclusion, comet assay will add new dimension to safety assessment of medical devices, and this assay can be added to the battery of genetic toxicology tests for evaluating biocompatibility of medical implants.

Genotoxicity studies with an ethanolic extract of Kalanchoe pinnata leaves.

Kalanchoe pinnata is a medicinal plant, used mainly in African, Brazilian, and Indian traditional medicine for the treatment of several human disorders. Whole leaf extracts, crude juice of the leaves, and aqueous and organic extracts of the leaves are used. Over the last decade, ethanolic extracts have become the most popular form of Kalanchoe medicinal preparation. In this study, an ethanolic extract of this plant leaf was tested in a battery of standard regulatory genetic toxicology tests. This extract did not induce reverse mutations in the Salmonella/microsome assay but induces a weak genotoxic response in the mouse lymphoma assay and the in vivo micronucleus assay in mice. Our results indicate that this material may cause DNA damage, and its use should be restricted.

Self-Healing Polyester Urethane Supramolecular Elastomers Reinforced with Cellulose Nanocrystals for Biomedical Applications.

Stretchable self-healing urethane-based biomaterials have always been crucial for biomedical applications; however, the strength is the main constraint of utilization of these healable materials. Here, a series of novel, healable, elastomeric, supramolecular polyester urethane nanocomposites of poly(1,8-octanediol citrate) and hexamethylene diisocyanate reinforced with cellulose nanocrystals (CNCs) are introduced. Nanocomposites with various amounts of CNCs from 10 to 50 wt% are prepared using solvent casting technique followed by the evaluation of their microstructural features, mechanical properties, healability, and biocompatibility. The synthesized nanocomposites indicate significantly higher tensile modulus (approximately 36-500-fold) in comparison to the supramolecular polymer alone. Upon exposure to heat, the materials can reheal, but nevertheless when the amount of CNC is greater than 10 wt%, the self-healing ability of nanocomposites is deteriorated. These materials are capable of rebonding ruptured parts and fully restoring their mechanical properties. In vitro cytotoxicity test of the nanocomposites using human dermal fibroblasts confirms their good cytocompatibility. The optimized structure, self-healing attributes, and noncytotoxicity make these nanocomposites highly promising for tissue engineering and other biomedical applications.

Antihyperlipidemic effect of iridoid glycoside deacetylasperulosidic acid isolated from the seeds of Spermacoce hispida L. - A traditional antiobesity herb.

ETHNOBOTANICAL RELEVANCE: The interest on herbal health supplements for obesity is increasing globally. Our previous ethnobotanical survey in Tiruvallur district, Tamil Nadu, India indicated the use of Spermacoce hispida L. seeds for the treatment of obesity. AIM OF THE STUDY: This study was aimed to validate the traditional claim and to identify the antihyperlipidemic principle in the seeds of Spermacoce hispida using bioassay guided fractionation method. METHODS: Bioassay monitored fractionation of the aqueous extract from Spermacoce hispida seeds was carried out using triton WR 1339 induced hyperlipidemic animals. It yielded deacetylasperulosidic acid (DAA) as the active ingredient. Pharmacokinetic properties of DAA were predicted using DataWarrior and SwissADME tools. In vitro antiobesity and antihyperlipidemic effects of DAA were evaluated in 3T3L1 preadipocytes and HepG2 cells, respectively. The chronic antihyperlipidemic efficacy of DAA was evaluated in high fat diet fed rats. RESULTS: DAA did not show any mutagenic and tumorigenic properties. It bound with PPARα with comparable ligand efficiency as fenofibrate. The treatment with DAA significantly lowered the proliferation of matured adipocytes, but not preadipocytes. The treatment of steatotic HepG2 cells with DAA significantly decreased the LDH leakage by 43.03% (P < 0.05) at 50 µM concentration. In triton WR 1339 induced hyperlipidemic animals, the treatment with 50 mg/kg dose significantly lowered the TC, TG and LDL-c levels by 40.27, 46.00 and 63.65% respectively. In HFD fed animals, the treatment at 10 mg/kg decreased BMI and AC/TC ratio without altering SRBG. It also improved serum lipid, transaminases and phosphatases levels of HFD fed animals. The treatment lowered adipocyte hypertrophy and steatosis of hepatocytes. CONCLUSION: This preliminary report supported the traditional use of Spermacoce hispida for the treatment of obesity. Further detailed investigations on the long term safety, efficacy and molecular mode of action of Spermacoce hispida and DAA will throw more light on their usefulness for the management of obesity.

Biocompatibility studies on cerium oxide nanoparticles - combined study for local effects, systemic toxicity and genotoxicity via implantation route.

An implantation study of cerium oxide nanoparticles (CeO2-NP) combined with 28-day systemic toxicity and genotoxicity studies aligned to current regulatory standards was conducted. The results suggested that local tissue reactions caused by CeO2-NP was minimal (implantation irritation index of less than 3) and was better tolerated than most other implant materials tested in our laboratory. Furthermore, CeO2-NP showed virtually no systemic toxicity or in vivo micronucleus induction in bone marrow via implantation route. Chemical analysis showed that CeO2-NP migrated from the implant sites (250 mg per site) in low levels and was deposited predominantly in liver (191.8 ± 35.1 ng g-1 of tissue; P < 0.01), lungs (263.4 ± 30.9 ng g-1 of tissue; P < 0.001), spleen (211.2 ± 6.5 ng g-1 of tissue; P < 0.001) and kidneys (272.8 ± 20.4 ng g-1 of tissue; P < 0.001). These observations provide a base line biocompatibility and toxicity data on CeO2-NP. The current findings will also be useful in defining standards for nanoparticle containing biomaterials and devices.

Pharmacological and toxicological evaluation of Sulcona(®), a traditional Siddha medicine used in the treatment of burns.

Sulcona, a Siddha proprietary medicine used for the treatment of burns, has been in practice for more than 50 years. This medicine has been successfully used on several burned patients with an excellent recovery and safety record. In this manuscript, we investigate some of its pharmacological and safety profiles. Treatment of cells with Sulcona induced a statistically significant increase in population doubling compared to concurrent controls in proliferating human lymphocytes as well as in Balb/c 3T3 cells, suggesting that it stimulates cell proliferation. Sulcona exhibited some antibacterial activity against Pseudomonas aeruginosa, Salmonella typhi and Staphylococcus aureus. Carrageenan-induced rat paw edema testing suggested that Sulcona has some anti-inflammatory properties. Patch testing showed that Sulcona has mild anesthetic effects. The above properties suggest Sulcona's pharmacological properties aidin treatment of burns. Sulcona did not show any skin irritation or sensitization or mutagenic potential suggesting that it is safe for use. Further work is necessary to elucidate its exact mechanisms of action.

Antimutagenic effect of broccoli flower head by the ames salmonella reverse mutation assay.

A study was performed to investigate the antimutagenic effect of broccoli flower head by the Ames Salmonella reverse mutation assay. Broccoli flower head being the most highly edible part in the plant was analysed for its antimutagenic effect. Without isolating the phytomolecules, the crude ethanol extract of broccoli flower head was tested for suppressing the mutagenic effect induced by certain chemical mutagens. Three strains - TA 98, TA102 and TA 1535 were used in the study. The tester strains were challenged with their respective mutagens. These were challenged with the ethanol extract of broccoli flower head at concentrations of 23 and 46 mg/plate. The plates were incubated for 72 h and the revertant colonies were counted. The crude extract did not prove to be promutagenic. The ethanol extract of the broccoli flower head at 46 mg/plate suppressed the mutagenic effect induced by the corresponding positive mutagens on all the three tester strains used in this study. The crude extract of broccoli flower head alone was not cytotoxic even at the maximum concentration tested (46 mg/plate). In conclusion, the ethanol extract of broccoli at 46 mg/plate suggests their diverse antimutagenic potential against the mutagenic chemicals employed in this study.