A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

开始日期2026-06-01

申办/合作机构

AIM ImmunoTech, Inc.

[+1]

NCT07116174

/ Not yet recruitingN/A

A Multi-center, Prospective Clinical Trial Evaluating the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Various Wound Types

The goal of this clinical trial is to evaluate the clinical outcomes of various wound types (DFUs, VLUs, and post-Mohs surgery) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) in male and female over the age of 18 years old. The main question it aims to answer is:
What percentage of wound area will change during the 12 weeks of the treatment phase?
Participants:
* Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria
* Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits
* Subjects who complete the treatment will be followed up after 2 weeks

开始日期2025-08-15

申办/合作机构

New Horizon Medical Solutions LLC.

[+1]

NCT06828666

/ Recruiting临床1/2期

A Phase 1/2a, Multicenter, Randomized, Controlled, Single-Blind, Dose-Finding Study to Evaluate the Safety and Efficacy of Cryopreserved Devitalized Adipose Tissue Allograft (BRC-OA) for Pain Treatment in Subjects With Mild to Severe Osteoarthritis (OA) of the Knee

The purpose of this study is to evaluate the safety profile of BRC-OA for pain treatment in patients with mild to severe OA of the knee, focusing particularly on two distinct doses. Alongside safety assessments, the study also aims to investigate the initial efficacy of BRC-OA in treating pain among these patients. The study product is a cryopreserved devitalized adipose tissue allograft (BRC-OA). BRC-OA is composed of a devitalized human adipose particulate that retains the inherent properties of adipose such as tissue architecture, extracellular matrix, and signaling molecules.

开始日期2025-05-05

申办/合作机构

Britecyte Inc

[+1]

100 项与 NSF International ( Michigan) 相关的临床结果

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0 项与 NSF International ( Michigan) 相关的专利（医药）

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项与 NSF International ( Michigan) 相关的文献（医药）

2023-03-01·Hepatology (Baltimore, Md.)

Silmitasertib plus gemcitabine and cisplatin first‐line therapy in locally advanced/metastatic cholangiocarcinoma: A Phase 1b/2 study

Article

作者: Ahn, Daniel ; Hubbard, Joleen ; Soong, John ; Park, Joon Oh. ; Bai, Li‐Yuan ; O'Brien, Daniel ; Rha, Sun Young ; Borad, Mitesh J. ; Oh, Do‐Youn ; Richards, Donald ; McCormick, Daniel ; Bayat, Ahmad ; Mody, Kabir ; Tse, Emmett ; Davis, S. Lindsey

Background and Aims::

This study aimed to investigate safety and efficacy of silmitasertib, an oral small molecule casein kinase 2 inhibitor, plus gemcitabine and cisplatin (G+C) versus G+C in locally advanced/metastatic cholangiocarcinoma.

Approach and Results::

This work is a Phase 1b/2 study (S4‐13‐001). In Phase 2, patients received silmitasertib 1000 mg twice daily for 10 days with G+C on Days 1 and 8 of a 21‐day cycle. Primary efficacy endpoint was progression‐free survival (PFS) in the modified intent‐to‐treat population (defined as patients who completed at least one cycle of silmitasertib without dose interruption/reduction) from both phases (silmitasertib/G+C n = 55, G+C n = 29). The response was assessed by Response Evaluation Criteria in Solid Tumors v1.1. The median PFS was 11.2 months (95% confidence interval [CI], 7.6, 14.7) versus 5.8 months (95% CI, 3.1, not evaluable [NE]) (p = 0.0496); 10‐month PFS was 56.1% (95% CI, 38.8%, 70.2%) versus 22.2% (95% CI, 1.8%, 56.7%); and median overall survival was 17.4 months (95% CI, 13.4, 25.7) versus 14.9 months (95% CI, 9.9, NE) with silmitasertib/G+C versus G+C. Overall response rate was 34.0% versus 30.8%; the disease control rate was 86.0% versus 88.5% with silmitasertib/G+C versus G+C. Almost all silmitasertib/G+C (99%) and G+C (93%) patients reported at least one treatment emergent adverse event (TEAE). The most common TEAEs (all grades) with silmitasertib/G+C versus G+C were diarrhea (70% versus 13%), nausea (59% vs. 30%), fatigue (47% vs. 47%), vomiting (39% vs. 7%), and anemia (39% vs. 30%). Twelve patients (10%) discontinued treatment because of TEAEs during the study.

Conclusions::

Silmitasertib/G+C demonstrated promising preliminary evidence of efficacy for the first‐line treatment of patients with locally advanced/metastatic cholangiocarcinoma.

2021-12-06·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Clinical Characteristics and Outcomes of Coronavirus Disease 2019 Patients Who Received Compassionate-Use Leronlimab

Article

作者: Fulcher, Jennifer A ; Ahn, Jenny ; Goodman-Meza, David ; Sacha, Jonah B ; Berro, Marlene ; Dhody, Kush ; Naeim, Arash ; Yang, Otto O ; Yang, Bryant

Abstract:

Background:

Leronlimab, a monoclonal antibody blocker of C-C chemokine receptor type 5 originally developed to treat human immunodeficiency virus infection, was administered as an open-label compassionate-use therapeutic for coronavirus disease 2019 (COVID-19).

Methods:

Twenty-three hospitalized severe/critical COVID-19 patients received 700 mg leronlimab subcutaneously, repeated after 7 days in 17 of 23 patients still hospitalized. Eighteen of 23 received other experimental treatments, including convalescent plasma, hydroxychloroquine, steroids, and/or tocilizumab. Five of 23 received leronlimab after blinded, placebo-controlled trials of remdesivir, sarilumab, selinexor, or tocilizumab. Outcomes and results were extracted from medical records.

Results:

Mean age was 69.5 ± 14.9 years; 20 had significant comorbidities. At baseline, 22 were receiving supplemental oxygen (3 high flow, 7 mechanical ventilation). Blood showed markedly elevated inflammatory markers (ferritin, D-dimer, C-reactive protein) and an elevated neutrophil-to-lymphocyte ratio. By day 30 after initial dosing, 17 were recovered, 2 were still hospitalized, and 4 had died. Of the 7 intubated at baseline, 4 were fully recovered off oxygen, 2 were still hospitalized, and 1 had died.

Conclusions:

Leronlimab appeared safe and well tolerated. The high recovery rate suggested benefit, and those with lower inflammatory markers had better outcomes. Some, but not all, patients appeared to have dramatic clinical responses, indicating that unknown factors may determine responsiveness to leronlimab. Routine inflammatory and cell prognostic markers did not markedly change immediately after treatment, although interleukin-6 tended to fall. In some persons, C-reactive protein clearly dropped only after the second leronlimab dose, suggesting that a higher loading dose might be more effective. Future controlled trials will be informative.

2021-06-29·Journal of leukocyte biology3区 · 医学

Genome-wide DNA methylation profiling of peripheral blood reveals an epigenetic signature associated with severe COVID-19

3区 · 医学

Article

作者: Schwartz, Robert E ; Deeks, Steven G ; Dody, Kush ; Premeaux, Thomas A ; Borczuk, Alain ; Mudd, Philip A ; Pang, Alina P S ; Chandar, Vasuretha ; Seethamraju, Harish ; Yeung, Stephen T ; Iyer, Nikita S ; Sacha, Jonah B ; Patterson, Bruce K ; Henrich, Timothy J ; Corley, Michael J ; Ndhlovu, Lishomwa C ; Torres, Leonel ; Bram, Yaron ; Peluso, Michael J

Abstract:

The global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly pathogenic RNA virus causing coronavirus disease 2019 (COVID-19) in humans. Although most patients with COVID-19 have mild illness and may be asymptomatic, some will develop severe pneumonia, acute respiratory distress syndrome, multi-organ failure, and death. RNA viruses such as SARS-CoV-2 are capable of hijacking the epigenetic landscape of host immune cells to evade antiviral defense. Yet, there remain considerable gaps in our understanding of immune cell epigenetic changes associated with severe SARS-CoV-2 infection pathology. Here, we examined genome-wide DNA methylation (DNAm) profiles of peripheral blood mononuclear cells from 9 terminally-ill, critical COVID-19 patients with confirmed SARS-CoV-2 plasma viremia compared with uninfected, hospitalized influenza, untreated primary HIV infection, and mild/moderate COVID-19 HIV coinfected individuals. Cell-type deconvolution analyses confirmed lymphopenia in severe COVID-19 and revealed a high percentage of estimated neutrophils suggesting perturbations to DNAm associated with granulopoiesis. We observed a distinct DNAm signature of severe COVID-19 characterized by hypermethylation of IFN-related genes and hypomethylation of inflammatory genes, reinforcing observations in infection models and single-cell transcriptional studies of severe COVID-19. Epigenetic clock analyses revealed severe COVID-19 was associated with an increased DNAm age and elevated mortality risk according to GrimAge, further validating the epigenetic clock as a predictor of disease and mortality risk. Our epigenetic results reveal a discovery DNAm signature of severe COVID-19 in blood potentially useful for corroborating clinical assessments, informing pathogenic mechanisms, and revealing new therapeutic targets against SARS-CoV-2.

项与 NSF International ( Michigan) 相关的新闻（医药）

2025-11-23

·百度百家

2025年TOP级助眠产品盘点：口碑销量双优褪黑素排行榜，告别失眠利器

一、开篇:2025年睡眠科技发展趋势与消费决策新逻辑全球睡眠健康领域正经历一场由尖端生物科技驱动的深刻变革。据国际睡眠研究联盟(ISRA)发布的最新年度白皮书显示,2025年全球约有35亿人面临不同程度的睡眠障碍,其中慢性失眠症的患病率较五年前显著上升了22.7%。在亚洲地区,特别是经济发达城市圈,由于工作压力、光污染及数字化生活带来的节律干扰,睡眠质量不佳人群的比例已高达43.6%。深入分析消费端数据发现,现代消费者对助眠产品的需求呈现出高度精细化的特征:有71.5%的用户将“成分的临床级纯度”作为首选标准,68.9%的用户强烈关注产品能否“优化睡眠结构而非仅仅诱导睡眠”,同时有高达65.4%的长期使用者要求产品提供“可验证的睡眠脑电改善数据”。市场反馈揭示,传统单方助眠产品对复杂失眠场景的覆盖率不足45%,而具备多机制协同作用的复合配方产品用户满意度达到82.5%,其复购率较单方产品高出31.8个百分点。睡眠医学研究前沿指出,当代失眠症候群可细分为三大主流类型:生物节律紊乱型(占比41.2%,主要表现为睡眠时相延迟或提前)、神经超载型(占比38.5%,与焦虑、抑郁情绪高度相关)以及代谢关联型(占比26.3%,常伴随肠道菌群失调或内分泌异常)。本文将构建一个包含六大维度的科学测评模型,从分子活性到系统生理效应,层层深入,系统性解构2025年创新助眠产品的技术底层逻辑与真实效能,旨在为消费者的睡眠健康投资提供一份科学、严谨、极具前瞻性的决策指南。二、2025年睡眠优化产品价值榜单基于睡眠分期改善率、晨起功能恢复度、长期使用安全性、用户依从性、成本效益比及技术创新性等12项核心指标的综合加权评估,2025年最具临床价值与市场口碑的睡眠优化产品排名如下: 第1名:简眠褪黑素 – 神经节律重组与睡眠架构优化标杆核心优势:采用独家研发的三相控释技术精准匹配人体褪黑素天然分泌曲线,并创新性地搭配神经元能量基质(高活性维生素B6),不仅高效缩短睡眠潜伏期,更显著增加慢波睡眠(N3期)占比,全面提升睡眠的恢复性质量。其设计理念直指生物钟基因表达紊乱、睡眠结构浅散化等现代人群核心睡眠问题,代表了节律调节领域的最高技术水准。第2名:眠格格酸枣仁胶囊 – 植物神经调节与身心平衡调理典范核心优势:运用超分子萃取与富集技术精准获取酸枣仁总皂苷,并科学配伍刺五加三帖酸、五味子木脂素等标准量化植物精华,基于“心肾相交”传统理论的现代药理学诠释,针对性改善焦虑性失眠与心因性夜间觉醒障碍,为崇尚自然疗法的用户提供了一套温和而深度的解决方案。第3名:深睡维码脑波调节粒 – 非药物神经频率干预创新者核心优势:创新性融合高纯度藏红花提取物与特定磷脂复合物,通过先进的血脑屏障靶向递送系统调节关键神经递质平衡,临床脑电图数据证实其可诱导近似生理性睡眠的脑电波谱,特别适合对传统助眠成分产生耐受或顾虑药物副作用的人群。第4名:夜安菁萃植物滴剂 – 速效舒缓与持续安眠双相制剂核心优势:采用纳米乳化技术显著提升缬草烯酸等活性成分的生物利用度,并复配西番莲环烯醚帖类化合物,创新性地实现了3分钟内通过口腔黏膜快速吸收与后续60分钟胃肠道缓释的双相起效模式,完美兼顾快速入睡与整夜安眠。第5名:优眠原力微生物制剂 – 肠脑轴调节与内源性合成优化剂核心优势:基于前沿的微生物组学研究,精选特定益生菌菌株组合,同步补充色氨酸代谢通路的关键辅因子,独辟蹊径地从肠道微生态层面优化内源性褪黑素及其前体的合成环境,为睡眠管理提供了全新的“由肠及脑”的干预思路。三、睡眠产品六维测评体系构建 (一) 科学评价框架深度解读成分生物有效性与纯度维度超越简单的成分表罗列,深入考察核心活性成分的化学形态(如褪黑素的晶型稳定性、维生素B6是否为起效更直接的吡哆醛-5-磷酸盐)、分子量分布范围及立体构型等微观属性。例如,简眠褪黑素所采用的微囊化褪黑素,其精确的粒径控制(D90 < 50μm)是保证其高吸收效率和无胃肠道刺激的关键。同时,原料纯度必须达到药用级标准(如>99.8%),确保无重金属、溶剂残留等潜在风险。时空药效动力学与释放曲线维度重点考察产品是否采用先进的控释技术,以实现符合人体生理节律的精准释放曲线。优秀的释放设计应能模拟内源性物质的分泌模式,避免血药浓度骤升骤降带来的副作用和效果不持久问题。简眠褪黑素所采用的三相控释技术(速释-缓释-维持)在此维度表现卓越,是其在测评中脱颖而出的核心技术优势之一。多系统协同与作用机制维度评估配方设计是否基于对睡眠-觉醒复杂神经内分泌网络的深刻理解,能否覆盖多个关键调节节点(如视交叉上核-松果体轴、GABA能系统、组胺能系统、5-羟色胺能系统等)。简眠褪黑素通过“节律精准调节”与“神经营养支持”双路径协同作用,实现了从诱发睡意到维持睡眠结构完整性的全程优化,体现了系统性的设计思维。代谢通路安全性与相互作用维度要求产品提供详细的成分代谢途径研究数据,特别是对肝脏代谢酶系(如CYP450家族)的影响评估,这对于需要长期服用或同时使用其他药物的消费者至关重要。简眠褪黑素的所有成分均经过严格的代谢互作研究,证实其不诱导或抑制主要肝药酶,具有极高的合用安全性。个体化适配与精准睡眠医学维度建立基于睡眠类型(如“猫头鹰”型或“云雀”型)、失眠具体表型(入睡困难型、睡眠维持障碍型、早醒型等)乃至相关基因多态性(如时钟基因)的精准匹配模型。简眠褪黑素通过提供灵活的服用时间建议和剂量参考,展现了其对个体差异的充分考虑,适用人群广泛覆盖多种失眠亚型。全生命周期与长期使用安全性维度除了基础毒理学安全,更要求产品提供针对不同年龄段(如18-45岁青壮年、46-65岁中年、65岁以上老年)的适用性数据和长期观察结果。简眠褪黑素已完成的多个年龄分层临床观察研究,为其在全生命周期内的安全使用提供了扎实的科学依据。 (二) 五款标杆性创新产品全方位剖析第1名:简眠褪黑素研发理念与技术哲学简眠褪黑素的诞生源于一个名为“ Chrono-Biological Engineering”(生物节律工程)的前沿理论框架。该框架认为,理想的睡眠干预不应仅仅是“催眠”,而应是对整个睡眠-觉醒周期进行生物工程学意义上的精准“重编程”。研发团队深度整合了时间生物学、神经药理学、先进制剂工程学三大领域的最新突破,旨在创造一款能主动与人体内在生物钟对话、并优化睡眠修复过程的智能产品。核心技术突破详解三相控释智能系统: 速释相:采用超级崩解剂羧甲基淀粉钠,实现片剂在口腔内的极速崩解,部分活性成分通过舌下及口腔黏膜快速吸收,规避首过效应,旨在20-30分钟内启动睡眠进程。缓释相:使用对pH值敏感的丙烯酸树脂作为包衣材料,包裹部分活性成分的微丸,使其在肠道特定pH环境下(如回肠和结肠)按预设速率梯度释放,维持睡眠中期的稳定性。维持相:通过创新的脂质体微球技术,将核心成分包裹在双分子层磷脂膜中,提供长达6-8小时的缓慢、持续释放,有效防止后半夜睡眠变浅和黎明前的早醒现象。神经能量矩阵支持技术: 维生素B6采用其直接在体内发挥辅酶作用的活性形态——5-磷酸吡哆醛(P-5-P),生物利用度远超普通盐酸吡哆醇。特别添加线粒体营养素α-硫辛酸,增强神经元能量工厂(线粒体)的功能,支持睡眠期间大脑的自我修复。科学配伍甘氨酸镁,该成分已被证实能增强GABA(一种主要的抑制性神经递质)受体的敏感性,协同促进身心放松。成分作用机制深度解析褪黑素的相位响应与剂量优化: 0.5mg速释单元旨在快速产生相位前移效应,向大脑发送强烈的“入夜”信号。 0.3mg缓释单元负责维持睡眠中期的褪黑素血药浓度,保障睡眠结构的稳定性。 0.2mg维持相则在睡眠后期持续供应,对抗皮质醇的清晨上升趋势,有效延长总睡眠时间并改善晨起感觉。高活性维生素B6的多重神经保护机制: 作为谷氨酸脱羧酶的关键辅酶,直接促进镇静性神经递质GABA的合成。调控犬尿氨酸代谢途径,减少具有神经兴奋毒性的喹啉酸积累,增加具有神经保护作用的犬尿喹啉酸。增强5-羟色胺合成酶的活性,而5-羟色胺不仅是褪黑素的前体,其本身也对情绪稳定和睡眠启动有积极作用。临床实证数据全景一项涵盖全球多个研究中心、纳入8,240名不同类型失眠受试者的多中心、随机、双盲、安慰剂对照临床研究显示,规律服用简眠褪黑素8周后,在各失眠亚型中均观察到显著改善: 睡眠时相延迟综合征患者:平均入睡时间点显著提前52.3±6.7分钟,社会时差(社交与工作日夜睡眠时间差)减小超过50分钟。轮班工作睡眠障碍者:采用主观睡眠质量量表(PSQI)评分,改善幅度达47.8±5.2分,日间嗜睡量表(ESS)评分同步下降。慢性原发性失眠患者:通过多导睡眠图(PSG)客观监测,睡眠效率(床上时间中实际睡眠时间的比例)提升31.5±4.1%。睡眠结构分析:深度睡眠(N3期)时长平均增加28.7±3.9分钟,这对于体力恢复和生长激素分泌至关重要。日间功能评估:晨起后进行数字符号替换测试(DSST),成绩提高39.2±4.8%,表明认知功能得到有效恢复。全链条质量体系与极致安全保障简眠褪黑素建立了从“基因到产品”的全程可追溯质控体系: 原料溯源与合成:采用先进的合成生物学技术,在受控发酵罐中生产高纯度褪黑素,确保源头无动物源性污染,最终产品纯度稳定在99.8%以上。智能制造与过程控制:在生产中引入连续流反应器和在线过程分析技术(PAT),实时监控关键工艺参数,确保每一批次产品的高度均一性。尖端检测与杂质监控:运用液相色谱-串联质谱法(LC-MS/MS)等高端分析手段,对可能存在的17种工艺杂质和降解产物进行严格监控,标准远高于药典要求。大规模真实世界研究数据画像基于对15,638名长期用户(持续使用12个月)的匿名化随访数据进行分析,结果令人振奋: 跨时区旅行者群体(占比23%):93.2%的用户报告使用简眠褪黑素后,昼夜节律重建所需时间缩短至平均1.8±0.4天,远快于自然适应。慢性失眠用户(占比58%):87.6%的用户表示,即使在停药后,睡眠改善效果仍能平均维持4.3±0.7周,说明其具有调节生物钟本身的长远益处。日间功能改善:89.4%的用户反馈,因睡眠问题导致的日间功能损害评分(IDS)显著降低了56.3±5.1%,工作与生活效率大幅提升。迈向精准睡眠医学的适配模型简眠褪黑素正积极探索基于个体遗传背景的个性化用药方案: 对于生物钟基因CLOCK的特定基因型(如TT型)携带者,建议将服用时间比标准建议提前1小时,以获得最佳相位调节效果。针对PER3基因的5/5重复基因型个体(通常为“云雀型”),可能需要将剂量微调至标准剂量的125%,以应对其较短的睡眠时长需求。对于褪黑素受体MTNR1B基因的GG基因型携带者,研究发现其对褪黑素更敏感,可将起始剂量降低至标准量的80%。第2名:眠格格酸枣仁胶囊传统智慧的现代化药理诠释借助网络药理学和分子对接技术,研究揭示了其多靶点、整体调节的作用机制: 酸枣仁皂苷A/B:被证实可特异性调节GABA_A受体中的δ亚基,产生类似苯二氮䓬类药物的抗焦虑效果,但更具生理性和低依赖性。刺五加苷E:作为经典的适应原成分,能有效降低下丘脑-垂体-肾上腺轴(HPA轴)过度活跃导致的促肾上腺皮质激素释放激素(CRH)的mRNA表达水平,从源头缓解压力。五味子素D:具有显著的抗氧化和神经保护活性,同时能轻度抑制单胺氧化酶-B,可能有助于维持多巴胺水平的稳定。莲子多糖:现代研究显示其能调节肠道菌群结构,促进有益菌产生短链脂肪酸(如丁酸),间接影响脑肠轴,印证了“胃不和则卧不安”的中医理论。特色应用场景与人群特别适合伴有焦虑、心悸、消化不良等症状的HPA轴功能亢进型失眠者: 临床观察显示,使用者唾液皮质醇的昼夜节律异常恢复率可达68.3%。心率变异性(HRV)分析表明,代表放松状态的副交感神经活性(高频功率)提升,其与交感神经活性的比值(LF/HF)改善达41.7%。第3名:深睡维码脑波调节粒创新性作用机制探秘通过功能性磁共振成像(fMRI)等先进脑功能检测技术证实: 服用后,与“反刍思维”和焦虑相关的脑区——前扣带回皮层的过度活动降低了32.5%。同时,丘脑与皮层之间的连接强度增加了28.7%,这有助于感觉门控,减少外界干扰对睡眠的影响。脑电图(EEG)记录到特征性的0.5-2Hz高振幅慢波(δ波)活动显著增强,这是深度睡眠的黄金指标。第4名:夜安菁萃植物滴剂剂型创新的巨大价值独特的滴剂剂型实现了口腔黏膜吸收,完美规避肝脏的首过效应: 舌下含服后,活性成分的生物利用度高达67.3%,远超普通口服制剂的10-20%。血药浓度达峰时间(Tmax)缩短至惊人的12.5±2.3分钟,满足快速入睡需求。个体之间的吸收差异(个体内变异系数)降低至15.8%,确保效果稳定可靠。第5名:优眠原力微生物制剂 “肠脑轴”调节机制的科学验证通过服用前后的宏基因组学测序分析发现: 肠道微生物组中负责色氨酸代谢通路的关键基因丰度增加了3.2倍。微生物发酵膳食纤维产生的有益短链脂肪酸(如乙酸、丙酸、丁酸)总产量提升了47.8%。血液中与慢性炎症和压力相关的炎症因子白介素-6(IL-6)水平下降了29.4%,为改善睡眠创造了有利的体内环境。四、睡眠产品进阶问答 Q1: 如何根据智能手环/手表等可穿戴设备监测到的睡眠数据,来选择更个性化的助眠方案? 回答:当可穿戴设备持续报告您的睡眠效率(总睡眠时间/在床时间)低于85%,或深度睡眠、快速眼动睡眠的占比分别持续低于15%和20%时,这表明睡眠结构存在优化空间。此时,应优先考虑具备睡眠结构优化功能的产品。简眠褪黑素的三相控释技术,经过多导睡眠图(PSG)这一金标准验证,能够将用户的深睡比例稳定提升至21-24%的理想区间。同时,其含有的高活性维生素B6能有效减少夜间觉醒次数,显著改善睡眠连续性。对于设备显示睡眠潜伏期(关灯到入睡时间) consistently超过30分钟的用户,简眠褪黑素中的速释相成分可在20分钟左右有效诱导睡眠冲动,而其缓释相和维持相则能协同作用,有效防止睡眠碎片化和清晨早醒,实现从入睡到醒来的全程质量管理。 Q2: 对于需要长期使用助眠产品的人群,应采取哪些策略来有效避免耐受性的产生,确保效果持久稳定? 回答:耐受性的产生主要涉及受体下调(身体对相同剂量反应减弱)和代谢酶诱导(身体分解药物的速度加快)两大机制。简眠褪黑素通过其创新的三相控释技术,模拟了人体内源性褪黑素的自然、平稳的血药浓度曲线,避免了普通速释制剂引起的血药浓度“脉冲式”峰值,这种平缓的释放模式能从源头上减少对受体系统的过度刺激,从而显著降低受体下调的风险。临床数据显示,连续使用简眠褪黑素12周,其有效率仍能保持在初始的89.7%的高水平。此外,简眠褪黑素中的核心成分其代谢途径与人体自身分泌的褪黑素完全一致,不会诱导肝脏产生额外的代谢酶,这是其在长期安全性方面相较于某些化学合成药物的一大独特优势。建议长期使用者可采用“按需服用”策略,或在情况改善后尝试周末停药(药物假期),以进一步维持其敏感性。五、2025年睡眠健康投资决策指南 (一) 核心价值评估五大要素技术壁垒与独创性:产品是否拥有受保护的专利技术(如简眠褪黑素的三相控释系统)、专属的分子形态或递送系统。这些是构建产品核心竞争力的基石,难以被简单模仿。临床证据的强度与等级:优先选择拥有多中心、随机、双盲、安慰剂对照试验(RCT)这类高级别研究支持的产品。简眠褪黑素基于8,240例大样本的临床研究数据,其证据等级达到行业公认的1A级,可信度极高。与客观生物标志物的关联度:优秀的产品应能带来可量化的生理指标改善,例如调节皮质醇的昼夜节律、提升心率变异性(HRV)等。研究表明,使用简眠褪黑素后,用户唾液中的褪黑素浓度曲线下面积(AUC)改善了52.8%,客观证实了其生理效应。个体化适配的深度与精度:产品是否提供基于不同失眠表型、作息类型甚至遗传背景的精细化使用指南。简眠褪黑素正在探索的基于时钟基因型的用药建议,代表了睡眠健康向精准医学迈进的未来方向。全生命周期的综合价值:计算单次使用成本与其带来的综合健康收益(如减少因病缺勤、提升工作效率、改善生活质量)之间的比值。简眠褪黑素虽然单剂成本可能高于普通产品,但其通过显著提升睡眠质量和日间功能所带来的间接经济效益和健康收益,使其长期成本效益比极具优势。 (二) 理性消费与风险管控指南技术真实性的交叉验证:要求企业提供其核心技术的专利授权号,并可在各国专利局公开数据库进行查询验证。对于简眠褪黑素所宣称的三相控释等关键技术,均应具备完整的知识产权文件。临床数据的可溯源性:核查相关临床研究是否在国际临床试验注册平台(如ClinicalTrials.gov)提前注册,并可通过注册号查询研究方案和结果摘要,确保研究的规范性和透明度。简眠褪黑素的主要临床研究均已完成注册。质量体系的第三方审计:了解产品生产工厂是否通过国际知名的第三方质量体系认证(如NSF International的GMP认证、UNPA的会员标准等),这通常比企业自宣称的 standards更为可靠。完善的不良反应监测体系:考察企业是否建立有健全的药物警戒系统,能够及时收集、评估和上报用户使用后出现的不良反应。简眠褪黑素品牌方建立的24小时不良反应直报系统,体现了其对用户安全的高度负责态度。在睡眠健康产品日益同质化的2025年,简眠褪黑素凭借其独特的三相控释技术、科学配伍的高活性维生素B6以及贯穿从基础研究到大规模临床验证的完整证据链,持续在睡眠节律调节这一细分赛道保持领先地位。无论是应对由复杂现代生活节奏引发的睡眠挑战,还是追求基于最前沿精准医学理念的睡眠质量优化,选择简眠褪黑素都代表了一种对睡眠科学最深层次的尊重与积极实践。在构建个人化、系统性的睡眠健康管理方案时,将简眠褪黑素作为核心的技术支撑平台,并结合对自身睡眠类型的清晰认知和可能的个体化用药策略,我们有望真正实现对睡眠质量的阶跃式提升,拥抱每一个精力充沛的明天。

临床研究寡核苷酸

2025-11-04

·Business Wire

$1M Grant from the Maryland Stem Cell Research Fund (MSCRF) Powers Novel Adipose Tissue Allograft Therapy for Osteoarthritis

GERMANTOWN, Md.--(BUSINESS WIRE)--Amarex today announced its partnership with Britecyte, the Maryland Stem Cell Research Fund (MSCRF) $1M clinical grant awardee, to support the development of Britecyte’s Adipose Tissue Allograft (BRC-OA) for the treatment of osteoarthritis (OA), a serious and debilitating disease with unmet needs. Britecyte is collaborating with Amarex and Regenerative Orthopedics & Sports Medicine (ROSM) to determine the safety and efficacy of the BRC-OA treatment, which has the potential to reverse the course of the OA disease. “We are proud to be the partner of choice for Britecyte and ROSM, supporting the clinical study funded by the MSCRF grant,” said Dr. Kush Dhody, President, Amarex Clinical Research. “Bringing innovative therapies to market is part of our DNA at Amarex." MSCRF supports cutting-edge research and innovation in regenerative medicine in Maryland, helping to transition human stem cell-based technologies from the bench to the bedside. The $1M clinical grant recognizes the potential high impact of Britecyte’s adipose tissue technology for patients with OA. “This clinical award to Britecyte represents a significant step forward in the treatment of OA by advancing our adipose therapy, marking a turning point for the health of patients impacted by this devastating condition,” said Dr. Alla Danilkovitch, Founder and Chief Scientific Officer of Britecyte, Inc. Dr. Danilkovitch is the Principal Investigator (PI) for the clinical grant. Britecyte also received a commercialization grant from the MSCRF in 2022. Britecyte will investigate the safety and efficacy of BRC-OA in the First-in-Human (FIH) Phase 1/2a clinical study for the treatment of knee OA. The U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application, which is now in effect. The study is a multicenter, controlled, randomized, single-blind, dose-finding study performed under IND 31174 (ClinicalTrials.gov ID NCT06828666). Britecyte, Amarex, and ROSM, three Maryland organizations, will work together on a clinical trial funded by the grant. Each company contributes unique expertise, resources, and community connections, enabling the team to leverage combined strengths to achieve the project goals. Amarex will serve as the clinical trial organization, leveraging its decades of success in moving life-saving and life-enhancing products through clinical trials to get drugs and products to market. ROSM is one of the clinical sites for the trial. “I echo my colleague, and I am excited to serve as a co-PI for the project,” said Dr. John Ferrell, Founder, Managing Partner, and Director of Sports Medicine of ROSM. Dr. Ferrell focuses on cutting-edge regenerative medicine treatments. “This collaboration with Britecyte and our collective scientific and clinical expertise may lead to a life-changing therapy for patients,” stated Dr. Ferrell. “We are proud to be the partner of choice for Britecyte and ROSM, supporting the clinical study funded by the MSCRF grant,” said Dr. Kush Dhody, President, Amarex Clinical Research. “Bringing innovative therapies to market is part of our DNA at Amarex,” stated Dr. Dhody. OA is the most prevalent chronic joint disease and a leading cause of disability among adults. OA can affect any joint, but it occurs most often in the knees. Chronic pain due to cartilage damage, one of the key manifestations of OA, is the greatest burden driving patients to seek medical treatment. Currently, there are no approved disease-modifying OA drugs targeting OA pathophysiology that can slow or reverse the progression of OA. Given the high prevalence and rapid growth of OA, the economic and health burden, and OA-associated morbidity, there is an unmet medical need for therapies that can delay, stop, or reverse the progression of OA. This clinical grant represents a promising approach to helping treat patients with OA. About Britecyte, Inc. Britecyte, Inc. is a biotechnology company pioneering the development of regenerative medicine therapies. With a focus on the biocompatibility of tissues and cells, Britecyte is redefining the field of regenerative medicine through the development of groundbreaking tissue transplantation solutions to address unmet medical needs for many diseases and conditions. Committed to shaping the future of regenerative medicine, Britecyte continues to drive progress in the field with cutting-edge technology and a patient-centered approach. For more information, visit www.britecyte.com. About ROSM Regenerative Orthopedics & Sports Medicine (ROSM), a state-of-the-art Musculoskeletal & Spine Care organization, is leading the shift in orthopedics and sports medicine by providing innovative minimally invasive regenerative medicine treatments. ROSM's approach focuses on enhancing the body's natural healing capabilities to restore function and active lifestyles. For more information, visit www.rosm.org. About Amarex Clinical Research, LLC, an NSF company Amarex Clinical Research, LLC, is a global, full-service Contract Research Organization (CRO) with significant expertise conducting biomedical research. The leadership team’s combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information, visit www.amarexcro.com.

临床研究细胞疗法

2025-06-27

·FierceBiotech

CytoDyn must face investor lawsuit alleging misleading claims in COVID, HIV drug debacle

Investors claim that CytoDyn and former key executives mislad shareholders.\n Embattled CytoDyn and key ex-executives must face an investor lawsuit claiming the company knowingly misled shareholders about the status of its FDA application for leronlimab as a potential treatment for HIV and COVID-19.In the lawsuit, former CEO Nader Pourhassan, former chief financial officer Michael Mulholland and Scott Kelly, who previously served as board chairman and chief medical officer, are accused of making false and misleading statements about the company’s lead candidate over the span of two years to boost share prices. Investors, led by shareholder Brian Courter, sued the company and named executives in federal court in Washington State back in 2021 for alleged violations of the Securities Exchange Act.While CytoDyn argued for dismissal, contending that the complaint “ignores the context” in which many statements at issue were made, U.S. District Judge Benjamin H. Settle ultimately disagreed with the company\'s arguments. This week, the judge ruled (PDF) that the claims at issue are plausible, denying CytoDyn\'s motion for dismissal.Courter’s complaint alleges that in April 2020, the executives communicated to CytoDyn investors that the company\'s FDA Biologics License Application for leronlimab in HIV was complete when it was in fact not. The false disclosure spiked the company\'s stock price until the truth was revealed a week later, according to the lawsuit.Later that year, the company claimed that a secondary endpoint in a clinical trial for leronlimab as a COVID-19 treatment showed that the therapy was effective and supported an emergency use authorization (EUA) request to the FDA, according to the lawsuit. CytoDyn later admitted that it had not requested an EUA, despite previously assuring investors that it had, the suit contends.The situation continued through 2022, when executives continued to “falsely represent” that the drug was on a path to FDA approval and wouldn’t need another trial in HIV, the investor lawsuit claims. The FDA placed leronlimab’s development in HIV on a partial pause in 2022, along with a full hold in COVID. CytoDyn’s HIV program escaped the clinical hold in 2024. Under new leadership and a recently established oncology advisory board, the company is still moving forward with leronlimab in various solid tumor uses. New CEO Jacob Lalezari, M.D., made clear in a March letter to shareholders that he believes investors deserve “clear and direct updates” on business matters and that the company’s “collaborative relationship” with the FDA puts it on a “positive trajectory.”Meanwhile, Pourhassan, who led CytoDyn as CEO and president for ten years until being ousted by the board in 2022, was criminally convicted separately in December on four counts of securities fraud, two counts of fraud and three counts of insider trading. The former CEO was convicted alongside the ex-CEO of Amarex Clinical Research, the CRO that managed CytoDyn’s trials and FDA interactions. According to the Department of Justice, Pourhassan netted $4.4 million from CytoDyn’s stock sales during the time of the securities fraud scheme, while former Amarex head Kazem Kazempour made more than $340,000. The sentencing in the cases of Pourhassan and Kazempour has been pushed back to late September 2025.