ISBT 128 implementation plan for cellular therapy products

The publication of new standards for terminology and labeling marks an important step in ensuring consistency and traceability of cellular therapies at the global level. However, it is only with the widespread implementation of the standard that the benefits can be truly realized. This paper provides guidance on the practical aspects of adopting these new standards for organizations with differing current levels of computerization. It discusses project management, equipment, licensing, and validation topics.     

硝酸甘油与克罗卡林合用抗大鼠心肌缺血的药理性预适应

目的:观察克罗卡林和硝酸甘油两药单用及合用抗大鼠心肌缺血的药理性预适应早期心脏保护作用。方法:实验于2005-10/2006-05在辽宁医学院药理学实验室进行。①实验分组和方法:取60只雄性SD大鼠随机分为6组,每组10只:假手术组:完成模型全部操作,只穿线不结扎。缺血再灌注组:采用左冠状动脉下穿线,拉紧丝线引起心肌缺血,放松丝线给予再灌注的方法建立心肌缺血再灌注损伤动物模型,缺血30min,再灌注60min。缺血预适应组:缺血前行缺血5min再灌注5min,共3个循环,余同缺血再灌注组。硝酸甘油组:100μg/kg尾静脉缓慢静脉滴注1h,再行缺血再灌注。克罗卡林组:100μg/kg尾静脉缓慢静注,30min后行缺血再灌注。硝酸甘油 克罗卡林组:缺血前1h静滴硝酸甘油100μg/kg,30min时静注克罗卡林,再行缺血再灌注。②实验评估:各组大鼠在再灌注60min后,经颈动脉取血采用比色法测定肌酸激酶;于实验结束后立即取左室游离心肌组织0.5g,采用羟胺法测定超氧化物歧化酶活性,硫代巴比妥钠比色法测定丙二醛含量,硝酸还原酶法测定一氧化氮含量,用虫荧光素酶法测定ATP含量。结果:60只大鼠进入结果分析。①血清中肌酸激酶活力:缺血预适应组、硝酸甘油组、克罗卡林组和硝酸甘油 克罗卡林组均低于缺血再灌注组(P<0.05),硝酸甘油 克罗卡林组下降更显著(P<0.01)。②心肌组织超氧化物酶活力:缺血预适应组、硝酸甘油组、克罗卡林组和硝酸甘油 克罗卡林组均高于缺血再灌注组(P<0.05或P<0.01),硝酸甘油 克罗卡林组高于硝酸甘油组、克罗卡林组(P<0.05)。③心肌组织内丙二醛含量:缺血预适应组、硝酸甘油组、克罗卡林组和硝酸甘油 克罗卡林组均低于缺血再灌注组(P<0.05或P<0.01)。④心肌组织内一氧化氮含量:缺血预适应组、硝酸甘油组、克罗卡林组和硝酸甘油 克罗卡林组均高于缺血再灌注组(P<0.05或P<0.0l),硝酸甘油 克罗卡林组高于硝酸甘油组、克罗卡林组(P<0.05)。⑤心肌组织ATP含量:缺血预适应组、硝酸甘油组、克罗卡林组和硝酸甘油 克罗卡林组均高于缺血再灌注组(P<0.05或P<0.01),硝酸甘油 克罗卡林组高于硝酸甘油组、克罗卡林组(P<0.05)。结论:硝酸甘油、色满卡林具有明显的抗大鼠心肌缺血的药理性预适应早期心脏保护作用,合用优于单用。     

Interlaboratory assessment of a novel colony-forming unit assay: a multicenter study by the cellular team of Biomedical Excellence for Safer Transfusion (BEST) collaborative

BACKGROUND: Interlaboratory scoring performances were determined using a traditional 14‐day colony‐forming unit (CFU) assay and a new 7‐day CFU assay. STUDY DESIGN AND METHODS: Digital images of colonies were utilized to train personnel at each site. A central laboratory inoculated methylcellulose with progenitors and sent the samples by overnight courier to participating labs for plating. RESULTS: Colony counts from two digital images showed greater variability by novice counters (coefficients of variation [CV], 18.5 and 23.0%; n = 8) than for experienced staff (CV, 7.3 and 4.8%; n = 5). CFU assays plated immediately, 24 and 48 hours after methylcellulose inoculation displayed 39.5 CFU, 37.1 ± 10.6 (CV, 28%) and 34.8 ± 8.5 (CV, 24%) colonies for the 7‐day assay and 39.5 CFU, 39.1 ± 9.9 (CV, 25%) and 37.1 ± 10.6 (CV, 28%) colonies for the 14‐day assay, respectively. Overall, no significant differences in colony counts were noted between assays (p = 0.68). Also, no differences in CFU counts were seen when assays were set up immediately, 24 and 48 hours after methylcellulose inoculation (14‐day p = 0.695; 7‐day p = 0.632). CONCLUSION: Total CFUs obtained in 7‐ and 14‐day CFU assays are comparable and show similar levels of interlaboratory variability. The major source of this variability is due to differences in how CFU plates are scored by individuals at different sites. UCB progenitor cells can be maintained in methylcellulose‐based media at room temperature for up to 48 hours prior to transport without a significant loss in CFUs.     

虎杖乙酸乙酯萃取部分抗人疱疹病毒研究

目的：ＨＳＶ可引起多种疾病,时洛韦（ＡＣＶ）治疗ＨＳＶ感染效果虽好,但易出现耐药毒株;新药Ｃｉｄｏｆｏｖｉｒ对ＡＣＶ耐药毒株效果好,毒性也大。ＨＳＶ疫苗临床实验效果也不好。为了解决这些问题,必须继续开发新药。虎杖是一种抗病毒范围广的中药毒株为了了解虎杖的生能并开发利用,我们对虎杖乙酸乙酯萃取部分的抗ＨＳＶ药效进行了研究。方法：我们以ＡＣＶ为阳性对照,利用病毒细胞病变抑制及空斑减数实验了药效,并且用     

Identities and frequencies of mutations of the otoferlin gene (OTOF) causing DFNB9 deafness in Pakistan

Mutations in OTOF , encoding otoferlin, cause non-syndromic recessive hearing loss. The goal of our study was to define the identities and frequencies of OTOF mutations in a model population. We screened a cohort of 557 large consanguineous Pakistani families segregating recessive, severe-to-profound, prelingual-onset deafness for linkage to DFNB9 . There were 13 families segregating deafness consistent with linkage to markers for DFNB9 . We analyzed the genomic nucleotide sequence of OTOF and detected probable pathogenic sequence variants among all 13 families. These include the previously reported nonsense mutation p.R708X and 10 novel variants: 3 nonsense mutations (p.R425X, p.W536X, and p.Y1603X), 1 frameshift (c.1103_1104delinsC), 1 single amino acid deletion (p.E766del) and 5 missense substitutions of conserved residues (p.L573R, p.A1090E, p.E1733K, p.R1856Q and p.R1939W). OTOF mutations thus account for deafness in 13 (2.3%) of 557 Pakistani families. This overall prevalence is similar, but the mutation spectrum is different from those for Western populations. In addition, we demonstrate the existence of an alternative splice isoform of OTOF expressed in the human cochlea. This isoform must be required for human hearing because it encodes a unique alternative C-terminus affected by some DFNB9 mutations.     

土贝母水提物对体外培养人肝癌细胞增殖及代谢的影响

目的研究中药土贝母(BPF)水提物对体外培养的人肝癌细胞的抑癌活性.方法 BPF经粉碎、浸提、超速离心、减压浓缩、冷冻干燥得BPF水提物.人肝癌SMMC-7721细胞经BPF提取物处理不同时间后以MTT法测其对人肝癌细胞线粒体代谢活性的影响,以细胞记数法观察了其对细胞增殖的影响.结果①经200 mg/L BPF提取物处理48 h,人肝癌SMMC-7721细胞线粒体活性为对照组的31.3%,处理72 h为21.4%;②以100mg/L BPF提取物处理7d中,人肝癌细胞数分别为0.57,0.316,0.29,0.285,0.57,1.287,1.2,对照FCS组分别为1.82,3.67,6.2,9.4,10.1,11,9,NON组分别为1.7,3.35,5.6,8.4,8.9,9.3,7.6,实验组人肝癌细胞数不仅低于对照组,而且低于处理前细胞数(P＜0.01);③经BPF提取物处理24 h后,即使更换为正常培养基,人肝癌细胞数在96 h的恢复培养中基本无增加.结论中药BPF提取物能显著抑制体外培养的肝癌细胞增殖和降低线粒体代谢活性.