Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan

自由診療で行われる再生医療の審査に関する課題を調査 今後の制度改正に期待. 京都大学プレスリリース. 2023-02-28.Questionable practices identified by an examination of therapeutic plan reviews performed by certified committees under the Act on the Safety of Regenerative Medicine. 京都大学プレスリリース. 2023-02-28.We outlined five studies regarding the quality of the review by committees based on the Act on the Safety of Regenerative Medicine. The findings raise serious concerns about the independence, integrity, and quality of reviews of therapeutic plans by these committees with inappropriately close relationships to medical institutions and companies

Extracellular Release of HMGB1 as an Early Potential Biomarker for the Therapeutic Response in a Xenograft Model of Boron Neutron Capture Therapy

Boron neutron capture therapy (BNCT) is a non-invasive therapeutic technique for treating malignant tumors, however, methods to evaluate its therapeutic efficacy and adverse reactions are lacking. High mobility group box 1 (HMGB1) is an inflammatory molecule released during cell death. Therefore, we aimed to investigate HMGB1 as a biomarker for BNCT response, by examining the early responses of tumor cells to 10B-boronophenylalanine (BPA)-based BNCT in the Kyoto University Nuclear Reactor. Extracellular HMGB1 release was significantly increased in human squamous carcinoma SAS and melanoma A375 cells 24 h after neutron irradiation but not after γ-irradiation. At 3 days post-BPA-based BNCT irradiation in a SAS xenograft mouse model, plasma HMGB1 levels were higher than those in the non-irradiation control, and HMGB1 was detected in both nuclei and cytoplasm in tumor cells. Additionally, increased plasma HMGB1 levels post-BNCT irradiation were detected even when tumors decreased in size. Collectively, these results indicate that the extracellular HMGB1 release occurs at an early stage and is persistent when tumors are reduced in size; therefore, it is a potential biomarker for evaluating the therapeutic response during BNCT

Assembly of a new gas-diffusion unit and its application to the determination of total carbonate and ammoniacal nitrogen by FIA.

今回新たに多孔質PTFE(polytetrafluoroethylene)チューブを分離膜とするガス透過装置を試作し,その性能について総炭酸定量用FIA装置を用いて検討した.新しいガス透過装置は組み立てが簡単で,前回製作のものに比べ,約10%の感度向上が達成され,更にピークのテイリングも減少した.本装置を組み込んだFIAにより環境水中の総炭酸,アンモニア態窒素の定量が可能である.いずれの場合もpH変化に伴うクレゾールレッドの呈色変化を測定に利用した.本法によれば多孔質ガス透過チューブ長8cmのとき,172mg dm(-3)(4×10(-3)mol dm(-3))以下の総炭酸を1時間当たり20試料,3.6mg dm(-3)(2.6×10(-4)mol dm(-3))以下のアンモニア態窒素を1時間当たり30試料の速さで測定できた.この際の検出限界(S/N=3に相当)は総炭酸の場合,0.96mg dm(-3)(2×10(-5)mol dm(-3)),アンモニア態窒素の場合は30μg dm(-3)(2×10(-6)mol dm(-3))であった.A new gas-diffusion unit was constructed and applied to determine total carbonate or ammoniacal nitrogen in water by spectrophotometric FIA. The gas diffusion unit, which was constructed without any glue, could be assembled easily by fastening the screws to tee connectors with ferrules. The new gas-diffusion unit was improved to decrease the dead volume. The unit gave sharper peaks than the previous one, and peaks higher by 10% in the case of CO(2) determination. The gas-diffusion part consisted of an inner microporous polytetrafluoroethylene (PTFE) tube (GORE-TEX®, 1.0 mm i.d., 1.8 mm o.d., pore size 2.0 μm, porosity 50%) and an outer PTFE tube (2.0 mm i.d., 3.0 mm o.d.). Sample solution was injected into the carrier solution (CS), in which the analyte was converted to a gaseous substance which passed through the microporous PTFE membrane to be mixed with the reagent solution (RS) flowing in the space between the outer and the inner tubings. The resulting pH shift caused the color of the indicator in RS to change. The conditions for the determination of total carbonate are as folows; CS was 1.8X×10(-3) mol dm(-3) H(2)SO(4), RS contained Cresol Red (at pH 9.0) and the detection wavelength was 410 nm. The detection limit was 0.96 mg dm(-3) CO(2) (S/N=3), the response was linear up to 172 mg dm(-3), and the sampling rate was 20 h(-1). For ammoniacal nitrogen, CS was 10(-2) mol dm(-3) NaOH, RS contained Cresol Red (pH 7.0) and absorbance was measured at 550 nm. The detection limit was 30μg dm(-3)NH(4)(+)-N (S/N=3), the response was linear up to 3.5 mg dm(-3), and the sampling rate was 30 h(-1). Total carbonate and ammoniacal nitrogen in river and seawater samples were determined satisfactorily