The present invention provides markers for judging the efficacy of therapy with a PD-1 signal inhibitor before or at an early stage of the therapy. As biomarkers for predicting or judging the efficacy of therapy with a PD-1 signal inhibitor, surrogate indicators of metabolic changes relating to mitochondrial activity in T cells and/or T cell activation in a subject are used. As such indicators, intestinal flora-related metabolites in the serum or plasma, energy metabolism-related metabolites in the serum or plasma, amino acid metabolism-related metabolites and/or derivatives thereof in the serum of plasma, oxygen consumption rate and/or ATP turnover in peripheral blood CD8.sup.+ cells, amino acids in T cells, and T-bet in peripheral blood CD8.sup.+ cells may be used.

It is an object to provide a therapeutic material for a skin ulcer which has excellent therapeutic effects on intractable skin ulcers such as decubitus ulcers with pockets and huge decubitus ulcers. By applying the therapeutic material for decubitus ulcers consisting of a fibrous material holding an antibiotic and a cell proliferation accelerator therein which is formed into an approximately spherical shape to a site of decubitus in a state in which a defect extending to the dermis, subcutaneous tissue, muscle or bone occurs, it is possible to treat critical skin ulcers such as intractable decubitus ulcers with pockets and huge intractable decubitus ulcers, as well as to treat not only relatively mild decubitus classified as stage II according to the US National Pressure Ulcer Advisory Panel (NPUAP) staging system, i.e., decubitus having ulcers in a state in which a part of the dermis is deficient, but also severe decubitus that has progressed to stage III to IV according to the NPUAP staging system, particularly decubitus with intractable ulcers with pockets or decubitus with huge intractable ulcers.

It is an object to provide a therapeutic material for a skin ulcer which has excellent therapeutic effects on intractable skin ulcers such as decubitus ulcers with pockets and huge decubitus ulcers. By applying the therapeutic material for decubitus ulcers consisting of a fibrous material holding an antibiotic and a cell proliferation accelerator therein which is formed into an approximately spherical shape to a site of decubitus in a state in which a defect extending to the dermis, subcutaneous tissue, muscle or bone occurs, it is possible to treat critical skin ulcers such as intractable decubitus ulcers with pockets and huge intractable decubitus ulcers, as well as to treat not only relatively mild decubitus classified as stage II according to the US National Pressure Ulcer Advisory Panel (NPUAP) staging system, i.e., decubitus having ulcers in a state in which a part of the dermis is deficient, but also severe decubitus that has progressed to stage III to IV according to the NPUAP staging system, particularly decubitus with intractable ulcers with pockets or decubitus with huge intractable ulcers.

A marker for determining a mental disease is provided. The marker can be used in an objective diagnosis of such a mental disease. The marker contains one or more enterobacteria of Bifidobacterium, Lactobacillus, Lactobacillus brevis, Lactobacillus reuteri subgroup, Lactobacillus sakei subgroup, Atopobium cluster, Bacteroides fragilis group, Enterococcus, Clostridium coccoides group, Clostridium leptum subgroup, Staphylococcus, Clostridium perfringens, and Enterobacteriaceae.

A marker for determining a mental disease is provided. The marker can be used in an objective diagnosis of such a mental disease. The marker contains one or more enterobacteria of Bifidobacterium, Lactobacillus, Lactobacillus brevis, Lactobacillus reuteri subgroup, Lactobacillus sakei subgroup, Atopobium cluster, Bacteroides fragilis group, Enterococcus, Clostridium coccoides group, Clostridium leptum subgroup, Staphylococcus, Clostridium perfringens, and Enterobacteriaceae.

It is an object to provide effective means for preventing and/or treating fulminant acute pneumonia. Provided are a pharmaceutical agent or pharmaceutical composition to be used for preventing and/or treating fulminant acute pneumonia, containing a CD69 antagonist, such as an antibody that specifically recognizes CD69 (anti-CD69 antibody), an agent for suppressing intra-alveolar neutrophil aggregation, containing a CD69 antagonist, such as an antibody that specifically recognizes CD69 (anti-CD69 antibody), an agent for suppressing pulmonary neutrophil infiltration, containing a CD69 antagonist, such as an antibody that specifically recognizes CD69 (anti-CD69 antibody), and a method of preventing and/or treating fulminant acute pneumonia, including administering a CD69 antagonist, such as an antibody that specifically recognizes CD69 (anti-CD69 antibody).

Disclosed are methods for treating or limiting development of diabetes, by transplanting into the eye of a subject with diabetes or at risk of diabetes an amount effective to treat or limit development of diabetes of insulin-producing cells engineered to reduce expression of a β3 subunit of Cav (Cavβ3).

The present invention relates to a fibrotic disease mechanism, and a preventive/therapeutic drug and method therefor. The present invention can improve the level of cAMP by means of a PDE inhibitor such as dipyridamole to treat fibrotic diseases and inhibit the progress of fibrosis. The present invention further achieves anti-inflammatory and immune regulation effects, and achieves a therapeutic effect on all aspects of the occurrence and development of fibrosis.

The present invention features a method comprising a metabolomic biomarker panel representing a metabolomic profile/fingerprint and methods of applying the profile to diagnose, monitor, and guide treatment for PAH. The profile comprises a unique panel of 36 metabolomic biomarkers/metabolites detected in plasma and/or urine obtained from the patient. The present invention allows for identification of patients with PAH in early-stage disease, before the condition has progressed sufficiently to produce clinical symptoms, and uniquely distinguishes PAH from pulmonary hypertension due to type 2 Diabetes Mellitus (DM) and/or left heart disease. The present invention allows for pre-screening of patients to identify PAH at the asymptomatic stage or help to minimize the time for PAH diagnosis after initial symptom onset.

Provided herein are methods and compositions, such as kits, related to compositions comprising synthetic nanocarriers comprising an immunosuppressant and compositions comprising an uricase and a composition comprising an anti-inflammatory therapeutic. Also provided herein are methods and compositions for the treatment of subjects in need of administration or treatment with the uricase.