双盲、安慰剂对照、随机临床试验证明端粒酶激活剂TA-65可降低人类免疫衰老的CD8+CD28-T细胞

G. Singaravelu, Edison Nj Usa Independent consultant, C. Harley, J. M. Raffaele, Pratheesh O. Sudhakaran, A. Suram, Murphys Ca Usa Independent consultant, New York Ny Usa PhysioAge
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引用次数: 4

摘要

TA-65是从黄芪中提取的一种小分子端粒酶激活剂。先前的一项观察性研究表明,TA-65降低了健康受试者的免疫衰老细胞数量。在这里,我们在一项更大规模的随机、双盲和安慰剂对照研究中检查了TA-65的影响。本研究旨在评估TA-65对健康受试者衰老的CD8+CD28-T细胞的影响。这是一项在500名健康受试者中进行的随机、双盲、安慰剂对照和多组平行试验。受试者、临床工作人员和主要结果评估员在数据库锁定之前一直处于盲态。共有500名健康志愿者被随机分配到五组中的一组,每组100名受试者;安慰剂、TA-65(100个单位)qd、TA-65(250个单位)qd、TA-65(500个单位)qd或TA-65(250个单元)b.i.d.测量9个月后免疫衰老生物标志物的变化。主要结果测量的意向治疗分析包括所有随机受试者(n=500)。根据方案,对测量的主要结果进行分析,包括93%的随机受试者(n=424)。多水平分析显示,与安慰剂组相比,TA-65干预组的CD8+CD28-T细胞显著减少(p<0.05)。100个单位和250个单位的TA-65 qd干预导致CD8+CD28-T细胞减少28个细胞/μl,而500个单位的TA-65干预导致CD8+CD28-T细胞减少22个细胞/µl;安慰剂摄入导致CD8+CD28-T细胞增加4.38个细胞/μl。没有任何严重不良事件(9)被认为与产品有关或不太可能与产品有关。34.6%的受试者出现轻度至中度不良事件。口服TA-65可显著降低CD8+CD28-T细胞。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Double-Blind, Placebo-Controlled, Randomized Clinical Trial Demonstrates Telomerase Activator TA-65 Decreases Immunosenescent CD8+CD28- T Cells in Humans
TA-65 is a small molecule telomerase activator extracted from Astragalus species. A previous observational study suggested that TA-65 decreased the number of immunosenescent cells in healthy subjects. Here we examined the impact of TA-65 in a much larger randomized, double-blind, and placebo-controlled study. This study aims to evaluate the effects of TA-65 on senescent CD8+CD28- T cells in healthy subjects. This was a randomized, double-blind, placebo-controlled, and multi-arm parallel trial in 500 healthy subjects. Subjects, clinical staff, and primary outcome assessors were blinded until the database lock. A total of 500 healthy volunteers were randomly allocated, 100 subjects each, into one of the five groups; placebo, TA-65 (100 Units) qd, TA-65 (250 Units) qd, TA-65 (500 Units) qd, or TA-65 (250 Units) b.i.d. Change in the immunosenescence biomarker after nine months was measured. The intention-to-treat analysis of the primary outcome measure included all the randomized subjects (n = 500). Per-protocol analysis of the primary outcome measured included 93% of the randomized subjects (n = 424). Multilevel analysis revealed a significant decrease in the CD8+CD28- T cells with TA-65 intervention compared to the placebo group (p<0.05). Intervention by 100 units and 250 units of TA-65 qd led to a decrement of CD8+CD28- T cells by 28 cells/μl, while the intervention by 500 units of TA-65 led to a decrement of CD8+CD28- T cells by 22 cells/μl; the placebo intake led to an increment of CD8+CD28- T cells by 4.38 cells/μl. None of the serious adverse events (9) were deemed related or were unlikely to be related to the product. Adverse events (AEs), ranging from mild to moderate severity were, observed in 34.6% of the subjects. Oral intake of TA-65 significantly decreased CD8+CD28- T cells.
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