Randomized, multicenter, active-controlled open-label study of NPC-25, zinc histidine hydrate, (non-inferiority to NOBELZIN™, zinc acetate dihydrate) for patients with hypozincemia.

Objective: This study evaluated the efficacy and safety of NPC-25, zinc histidine hydrate, in patients with hypozincemia. This randomized multicenter active-controlled open-label trial aimed to verify the non-inferiority of NPC-25 to NOBELZIN™, zinc acetate dihydrate.

Methods: Participants whose serum zinc concentrations were <70 μg/dL at two points within 8 weeks before the start of treatment were randomized 1:1 into the NPC-25 (active drug) administration group and the NOBELZIN™ (control drug) administration group, using dynamic allocation.

Human resources required in the field of regenerative medicine: A follow-up of the Japanese survey in 2015.

In 2015, we conducted a survey of the corporate members of FIRM on the human resources and training required in the field of regenerative cell therapies and reported the results in this journal. After that, industrialization of regenerative medicine has progressed and some cell products have been approved, and infrastructures, such as laws and educational systems, have been improved. To capture the changing demands for human resources in response to the shift in social circumstances, we conducted another survey.

Post-marketing surveillance of zinc acetate dihydrate for hypozincemia in Japan.

Zinc is an essential microelement, and its deficit causes various diseases and symptoms. In adults, especially in elderly individuals, zinc shortage can cause symptoms such as taste disorder, dermatitis, and susceptibility to infection. In children, zinc deficiency can lead to growth retardation.

A New Approach to Prepare Chiral Aroma: Asymmetric Oxidation of Ionols with a Heme Acquisition System A Derived from Symbiotic Fluorescent Bacteria.

The aim of this study was to propose an alternative route for preparing chiral β- and α-ionols by asymmetric oxidation with a heme acquisition system A (HasA) derived from symbiotic fluorescent bacteria as a biocatalyst. The HasA (6 g) in distilled water (300 mL) was stirred at 1150 rpm for 1 day at 40°C. Subsequently, a secondary alcohol (0.

The effects of continuous exposure to low-dose chlorine dioxide gas on the characteristics of induced pluripotent stem cells.

Background: Recently, various regenerative therapies have been developed based on induced pluripotent stem (iPS) cells. However, hygienic control strategies have not been established at the manufacturing facilities. We aimed to evaluate the safety and effects of continuous exposure to low-dose chlorine dioxide (ClO) gas on cell fates, and to determine the optimum dose for safe usage of this disinfectant.

Impaired B cell terminal differentiation in B cell-specific knockout mice of cell death-defying factor anamorsin.

Anamorsin (AM) is an anti-apoptotic molecule cloned by us as a molecule that confers resistance against apoptosis induced by growth factor deprivation. AM-deficient mice are embryonic lethal, which impedes detailed analyses of the roles of AM in various types of adult cells. To overcome the embryonic lethality, we generated AM conditional knockout (AM) mice and cell type-specific genetic modification became possible using the Cre-loxP system.

Pharmacokinetics, Safety, and Tolerability of NPC-21, an Anti-Cytomegalovirus Monoclonal Antibody, in Healthy Japanese and White Adult Men: A Randomized, Placebo-Controlled, First-in-Human Phase 1 Study.

NPC-21 (EV2038) is a fully human monoclonal antibody that targets the antigenic domain 1 of glycoprotein B on the human cytomegalovirus (hCMV) envelope. NPC-21 has been shown to have broadly neutralizing activity and to inhibit cell-to-cell transmission of hCMV in preclinical studies. It is currently in development for the prophylactic or preemptive treatment of hCMV in patients receiving a solid-organ transplant or hematopoietic stem cell transplant.

Effects of Psychological and Physical Stress on Oxidative Stress, Serotonin, and Fatigue in Young Females Induced by Objective Structured Clinical Examination: Pilot Study of u-8-OHdG, u-5HT, and s-HHV-6.

Background: To establish a method to prevent and manage fatigue caused by psychological and physical stress in young females, early detection factors, such as understanding of fatigue and causes of psychological and physical stress, as well as a review of early management of psychiatric disease, are important. With increasing knowledge regarding the diverse causes of stress, it is important to select biomarkers with consideration of the types of stress burden and mechanisms underlying the development of physical symptoms. The methods used to search for stress characteristics is an issue that needs to be addressed.

First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3).

Background: BK-SE36 is blood-stage malaria vaccine candidate that is undergoing clinical trials. Here, the safety and immunogenicity of BK-SE36 with a novel adjuvant, CpG-ODN(K3) (thus, BK-SE36/CpG) was assessed in a phase 1a trial in Japan.

Methods: An investigator-initiated, randomised, single-blind, placebo-controlled, dose-escalation study was conducted at Osaka University Hospital with 26 healthy malaria naïve Japanese male adults.

Ectonucleotidase CD39 is highly expressed on ATLL cells and is responsible for their immunosuppressive function.

Adult T-cell leukemia/lymphoma (ATLL) patients have an extremely poor prognosis, partly due to their immunosuppressive state. The majority of ATLL patients have leukemic cells with phenotype similar to Tregs, prompting suggestions that ATLL cells themselves have immunosuppressive functions. In this study, we detected CD39 expression on ATLL cells, particularly frequent on aggressive subtypes.

Effects of continuous exposure to low concentration of ClO gas on the growth, viability, and maintenance of undifferentiated MSCs in long-term cultures.

Introduction: Hygienic management is more important in the manufacturing of cell products than in the production of chemical agents, because cell material and final product cannot be decontaminated. On the other hand, especially in the selection of hygienic agent, the adverse effects on the cells must be considered as well as the decontamination effect. ClO is a potent disinfectant, which is now expected as a safe and effective hygienic agent in the field of cell production.

Understanding the formation and behaviors of droplets toward consideration of changeover during cell manufacturing.

Preventing the contamination of processed cells is required for achieving reproducible manufacturing. A droplet is one of the potential causes contamination in cell manufacturing. The present study elucidates the formation mechanism and characteristics of droplets based on the observation and detection of droplets on the base surface of the biological safety cabinet (BSC) where cell processing is conducted under unidirectional airflow.

Unexpected Complication of R-CHOP Chemotherapy: Rapidly Progressive Bronchiolitis Obliterans Syndrome.

Background: Bronchiolitis obliterans syndrome (BOS) is the term used for the progressive obliteration of small airways before the patient has had a confirmatory lung biopsy. It is also recognized as a transplant-related complication. There have been no reports of BOS during initial standard chemotherapy.

Endothelial Cell-Selective Adhesion Molecule Contributes to the Development of Definitive Hematopoiesis in the Fetal Liver.

Endothelial cell-selective adhesion molecule (ESAM) is a lifelong marker of hematopoietic stem cells (HSCs). Although we previously elucidated the functional importance of ESAM in HSCs in stress-induced hematopoiesis in adults, it is unclear how ESAM affects hematopoietic development during fetal life. To address this issue, we analyzed fetuses from conventional or conditional ESAM-knockout mice.

Effects of residual HO on the growth of MSCs after decontamination.

Introduction: Regenerative therapy is a developing field in medicine. In the production of cell products for these therapies, hygienic management is even more critical than in the production of a chemical drug. At the same time, however, care is required with the use of decontamination agents, considering their effects on cell viability and characteristics.

Trends in Policy on the Prevention and Control of Non-Communicable Diseases in Japan.

Abstract-For the past decades Japan has remained number one in a range of population health metrics including the world's longest healthy life expectancy. While this was achieved through various socioeconomic factors besides public health interventions, health promotion policies to prevent and control non-communicable diseases (NCDs) played a major role. Japan introduced its first comprehensive national plan to prevent and control NCDs in 1978 and has revised the plan every decade since.

The G7 presidency and universal health coverage, Japan's contribution.

Problem: If universal health coverage (UHC) is to be achieved globally, it needs sustained promotion and political awareness and support.

Approach: During its presidency of the Group of Seven (G7) industrialized nations in 2016, Japan aimed to raise the issue of UHC to the top of the global health agenda.

Local Setting: Japan has promoted a health agenda at all of the G7 summits since 2000 that it has hosted.

Population health and regional variations of disease burden in Japan, 1990-2015: a systematic subnational analysis for the Global Burden of Disease Study 2015.

Background: Japan has entered the era of super-ageing and advanced health transition, which is increasingly putting pressure on the sustainability of its health system. The level and pace of this health transition might vary across regions within Japan and concern is growing about increasing regional variations in disease burden. The Global Burden of Diseases, Injuries, and Risk Factors Study 2015 (GBD 2015) provides a comprehensive, comparable framework.

Human resource development contributes to the creation of outstanding regenerative medicine products.

Regenerative medicine is currently the focus of global attention. Countries all around the world are actively working to create new regenerative treatment modalities through pioneering research and novel technologies. This is wonderful news for patients who could not be treated with existing medical options.