0% (six of 15) in the control group (P=0.039). The incidence of retinopathy was 7.1% (one of 14) in the SCT group versus 33.3% (five of 15) in the control group (P=0.081). Two patients (two of 14, 14.3%) in the SCT group and 11 patients (11 of 15, 73.3%) in the control group developed at least one complication (P=0.001). One and six patients in the SCT group and control group, respectively, had at least two complications (P=0.039). No malignancies were reported in the treated group.

Co-transplantation of umbilical cord MSCs and aBM-MNCs in patients with established T1D was associated with reduced incidence of chronic diabetes complications.

Co-transplantation of umbilical cord MSCs and aBM-MNCs in patients with established T1D was associated with reduced incidence of chronic diabetes complications.

The COVID-19 pandemic has forced a fundamental change in the global procurement of allogeneic hematopoietic progenitor cells (HPCs) for transplantation. To better meet the emergent challenges of transporting cryopreserved allogeneic HPC during pandemics, there is an urgent need for External Quality Assurance (EQA) programs to evaluate reproducibility and harmonization of viable CD34

cell (vCD34

) HPC enumeration, as the current EQA programs are unsuitable for analysis of vCD34

. The cost-effective distribution of HPC cryopreserved reference samples (CRSs) with acceptable reproducibility and specificity is key to the success of a vCD34

EQA program.

Cryopreserved HPC samples (n=11) were either stored on dry ice for 1 to 4 days or for 1 day followed by liquid nitrogen (LN) storage for 1 to 3 days to assess optimal conditions for vCD34

EQA. Flow cytometric enumeration of vCD34

HPCs was performed using a single platform assay combined with 7-AAD viability dye exclusion. The optimum transportation condition was validated in pilot and multicenter national studies (n=12).

A combination of 1 day on dry ice followed by LN storage stabilized viability compared with continuous storage on dry ice. This study demonstrates that dispatch of CRSs on dry ice to recipient centers across a distance of ≤4000 km within 26 h, followed by LN storage, resulted in reproducible intercenter vCD34

enumeration. The estimated cost of safer and more convenient dry ice delivery is >20-fold lower than that of LN.

This approach can form the basis for economically and scientifically acceptable distribution of CRSs for external vCD34

EQA.

This approach can form the basis for economically and scientifically acceptable distribution of CRSs for external vCD34+ EQA.Embolic protection devices may decrease the risk of distal embolization during percutaneous coronary intervention of saphenous vein graft and highly thrombotic lesions. Use of a buddy wire can facilitate equipment delivery but carries perils when used together with a filter. We present two cases demonstrating potential complications of buddy wire use with a filter. In the first case a saphenous vein graft perforation occurred after stenting. A buddy wire and second balloon were used to maintain hemostasis while removing the Filterwire. The buddy wire, however, was caught in the filter retrieval catheter, interlocking the two guide catheters and was eventually removed after forceful pulling. In the second case a Filterwire was used to prevent distal embolization of a highly thrombotic right coronary artery lesion. A buddy wire was used to assist with equipment delivery. A stent was inadvertedly deployed over the buddy wire, entrapping the Filterwire. The entrapped Filterwire was eventually removed after multiple balloon inflations over the buddy wire.As one of the overreaching goals of Healthy People 2030, addressing the social determinants of health (SDOH) to reduce health disparities is a nationwide concern, with objectives informed by interdisciplinary teams of experts. However, there remains much discussion regarding the roles of healthcare providers in addressing SDOH. While current guidance suggests that all members of the healthcare team must be empowered to address SDOH, current guidance explicitly references physicians, nurses, social workers and staff, and do not specifically include pharmacists. While pharmacists are taught about the impact of SDOH in pharmacy curricula, actionable strategies for pharmacists to address SDOH in practice have not been clearly outlined. Pharmacists have multifaceted interactions with patients and may be influential in meeting individual patient needs, identifying social risk factors, and addressing upstream causes of health disparities. This paper proposes a framework for the role of pharmacists in addressing the SDOH through strategies at the patient, practice, and community levels. The concepts presented in this paper are meant to serve as a launch point for discussion and to promote the inclusion of pharmacists in the conversations around sustainable efforts to achieve health equity. This framework is not intended to limit the scope of pharmacists in addressing SDOH – on the contrary, it is our hope that this outline may be used to expand the education of future healthcare professionals regarding their role in addressing the social determinants of health.Gene editing allows the precise modification of cells to correct genetic defects or enhance immunotherapies. A limitation is the delivery of this technology to specific cells or organs. Recently, Banskota et al. reported the use of virus-like particles (VLPs) loaded with gene-editing agents for gene therapy delivery directly inside the body.SurgihoneyRO™ (SHRO) is a bioengineered medicinal honey proven to eradicate multi-drug resistant strains of bacteria by delivering a controlled dose of reactive oxygen species (ROS). The urgent need for novel antimicrobial therapies capable of tackling pathogens that have developed resitance to existing antimicrobial medicines, such as antibiotics, makes SHRO a highly desirable biomaterial. However, its application is currently limited in the medical field due to undesirable material properties. This study aims to formulate the honey into a clinically viable topical cream whilst maintaining antimicrobial efficacy. SHRO droplets were emulsified to protect the active until activation in-situ. Xanthan gum (XG) and fumed silica (FS) thickener systems were explored, with both formulations able to inhibit the growth of S. aureus in-vitro. However, FS formulations exhibited significantly higher hydrogen peroxide release over a period of 7 days and resulted in larger zones of inhibition (42%) than XG formulations. Selection of the optimum FS formulation was made based on evaluation of the material characteristics by means of rheology and texture analysis. In place of the sticky and highly viscous initial SHRO product, desirable material characteristics for a topical product were achieved, including thixotropic shear-thinning behaviour and significantly lower cohesiveness (15.3-22.4 N) than standard SHRO formulations (79.9 N). Furthermore, the product exhibited a low contact angle on porcine skin, indicating that these formulations would spread favourably on the skin surface, demonstrate a favourable sensory perception and be retained on the skin, making for a more clinically effective product. This work is the first report of an engineered cream system to controllably deliver ROS to a wound site and demonstrate its ability of eradicating clinically relevant bacteria in vitro.An international meeting, held in Munich, Germany, on 14-16 September 2021, explored the expectations and views of different stakeholders regarding the implementation of the new veterinary medicines Regulation (Regulation (EU) 2019/6) in respect to inactivated autogenous vaccines (AVs) in non-notifiable diseases. Guidance documents on specific Good Manufacturing Practice (GMP) for AVs are scheduled to be developed at EU and a wider international level in the future. Presentations and discussions by the experts from regulatory authorities, industry and users made it apparent that their views on the quality requirements for the starting materials as well as quality standards for premises, personnel and manufacturing were broadly aligned for most of the aspects considered. The conclusions and recommendations of this meeting are expected to facilitate the development of urgently needed guidance documents for a harmonised implementation of this element of the Regulation.Faecal microbiota transplantation (FMT) is widely reported to be an effective treatment against recurrent Clostridioides difficile infections. Recent clinical studies support the therapeutic use of FMT for several other pathologies including inflammatory bowel disease, several types of cancer, and other functional or metabolic disorders. Initial guidelines are now available to overcome some of the technical and logistical issues for establishing a non-standardized treatment into clinical practice with proper safety and governance. To aid the improvement of guidance and standardization requirements for FMT, the International Alliance for Biological Standardization (IABS) and the BIOASTER Microbiology Technology Institute hosted a joint online workshop in May of 2021. The goal of the webinar was to provide a multi-disciplinary perspective of the ongoing efforts to develop FMT guidelines including technical, regulatory, and standardization requirements. Recognized experts gave insights into state-of-the art approaches and standards developed by international organizations and institutions.

Cardiovascular disease is the leading cause of morbidity and mortality in individuals with type 1 diabetes mellitus (T1DM). Cardiovascular risk is higher in women with diabetes than in men. With this study, we wanted to determine whether female children and adolescents with T1DM are more prone to cardiovascular risk factors (CVRFs) and an atherogenic diet than boys.

For this cross-sectional study, anthropometric, clinical, biochemical, and dietary intake data of 314 children with diabetes (3-18 years; 178 boys) were analysed according to age and sex. Linear and binary logistic regression was performed to test independent associations between sex, dietary intake, and CVRFs. Low-density lipoprotein -cholesterol (LDL-c), triglyceride (TG), fibre, monounsaturated fatty acid levels (all p<0.01), and lipid (p=0.022) intake were higher in the girls than in the boys. Multiple regression analysis showed that LDL was associated with sex, glycated haemoglobin (HbA1c), and lipid intake percentage (R (Kannel, 1979) [2]=0.130; p=0.0004) independent of age, pubertal stage, body mass index (BMI), duration of diabetes, energy, and fibre intake. Logistic regression analysis showed that high LDL-c levels were present more often in girls [odds ratio, OR; confidence interval, CI=2.569 (1.178-5.604); p=0.018] who had a higher dietary lipid intake percentage [OR (CI)=1.089 (1.011-1.173); p=0.025].

Girls with diabetes have higher LDL-c levels associated with higher dietary lipid intake. Our findings suggest that young people with diabetes, especially girls, may benefit from early dietary interventions to reduce their cardiovascular risk.

Girls with diabetes have higher LDL-c levels associated with higher dietary lipid intake. Our findings suggest that young people with diabetes, especially girls, may benefit from early dietary interventions to reduce their cardiovascular risk.