• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

用于治疗阿尔茨海默病的 Lomecel-B 的 I 期临床试验结果和见解。

Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease.

机构信息

Brain Matters Research, Delray Beach, Florida, USA.

Miami Jewish Health, Miami, Florida, USA.

出版信息

Alzheimers Dement. 2023 Jan;19(1):261-273. doi: 10.1002/alz.12651. Epub 2022 Mar 31.

DOI:10.1002/alz.12651
PMID:35357079
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10084163/
Abstract

HYPOTHESIS

We hypothesized that Lomecel-B, an allogeneic medicinal signaling cell (MSC) therapeutic candidate for Alzheimer's disease (AD), is safe and potentially disease-modifying via pleiotropic mechanisms of action.

KEY PREDICTIONS

We prospectively tested the predictions that Lomecel-B administration to mild AD patients is safe (primary endpoint) and would provide multiple exploratory indications of potential efficacy in clinical and biomarker domains (prespecified secondary/exploratory endpoints).

STRATEGY AND KEY RESULTS

Mild AD patient received a single infusion of low- or high-dose Lomecel-B, or placebo, in a double-blind, randomized, phase I trial. The primary safety endpoint was met. Fluid-based and imaging biomarkers indicated significant improvement in the Lomecel-B arms versus placebo. The low-dose Lomecel-B arm showed significant improvements versus placebo on neurocognitive and other assessments.

INTERPRETATION

Our results support the safety of Lomecel-B for AD, suggest clinical potential, and provide mechanistic insights. This early-stage study provides important exploratory information for larger efficacy-powered clinical trials.

摘要

假设

我们假设 Lomecel-B 是一种同种异体药物信号细胞 (MSC) 治疗阿尔茨海默病 (AD) 的候选药物，通过多种作用机制具有安全性和潜在的疾病修饰作用。

主要预测

我们前瞻性地测试了以下预测：向轻度 AD 患者给予 Lomecel-B 治疗是安全的（主要终点），并将在临床和生物标志物领域提供多个潜在疗效的探索性指标（预先指定的次要/探索性终点）。

策略和主要结果

轻度 AD 患者在一项双盲、随机、I 期临床试验中接受了低剂量或高剂量 Lomecel-B 或安慰剂的单次输注。主要安全性终点得到满足。基于液体的生物标志物和影像学生物标志物表明，与安慰剂相比，Lomecel-B 组有显著改善。与安慰剂相比，低剂量 Lomecel-B 组在神经认知和其他评估方面有显著改善。

解释

我们的结果支持 Lomecel-B 用于 AD 的安全性，表明其具有临床潜力，并提供了机制见解。这项早期研究为更大规模的疗效驱动临床试验提供了重要的探索性信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/4547ca0ec8ec/ALZ-19-261-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/f1a3661a3523/ALZ-19-261-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/ab1936896db2/ALZ-19-261-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/4547ca0ec8ec/ALZ-19-261-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/f1a3661a3523/ALZ-19-261-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/ab1936896db2/ALZ-19-261-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab16/10084163/4547ca0ec8ec/ALZ-19-261-g002.jpg

相似文献

1
Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease.用于治疗阿尔茨海默病的 Lomecel-B 的 I 期临床试验结果和见解。
Alzheimers Dement. 2023 Jan;19(1):261-273. doi: 10.1002/alz.12651. Epub 2022 Mar 31.
2
The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty.一项评估 Lomecel-B 在衰弱老年人中的安全性和疗效的 2b 期、随机、双盲、安慰剂对照试验的设计和原理。
J Frailty Aging. 2022;11(2):214-223. doi: 10.14283/jfa.2022.2.
3
Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial.在双向腔肺吻合术治疗左心发育不全综合征期间使用Lomecel-B进行心肌内细胞治疗：ELPIS I期试验
Eur Heart J Open. 2023 Jan 11;3(2):oead002. doi: 10.1093/ehjopen/oead002. eCollection 2023 Mar.
4
Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer's disease (BLAZE).淀粉样蛋白正电子发射断层扫描和脑脊液结果来自 crenezumab 抗淀粉样蛋白-β 抗体在轻度至中度阿尔茨海默病（BLAZE）的双盲、安慰剂对照、随机 2 期研究。
Alzheimers Res Ther. 2018 Sep 19;10(1):96. doi: 10.1186/s13195-018-0424-5.
5
Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial.双盲、随机、对照临床试验评估同种异体间充质基质细胞治疗 COVID-19 所致急性呼吸窘迫综合征患者的疗效（COVID-AT）：一项随机对照试验的研究方案的结构总结。
Trials. 2021 Jan 6;22(1):9. doi: 10.1186/s13063-020-04964-1.
6
Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial.COVID-19 住院成人患者使用伊马替尼的安全性和疗效：一项随机对照试验研究方案的结构化总结。
Trials. 2020 Oct 28;21(1):897. doi: 10.1186/s13063-020-04819-9.
7
Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer's disease: results of a randomized, double-blind, placebo-controlled phase 2a study.谷氨酰胺环化酶抑制剂 PQ912 在阿尔茨海默病中的安全性、耐受性和疗效：一项随机、双盲、安慰剂对照 2a 期研究的结果。
Alzheimers Res Ther. 2018 Oct 12;10(1):107. doi: 10.1186/s13195-018-0431-6.
8
Safety and efficacy of pioglitazone for the delay of cognitive impairment in people at risk of Alzheimer's disease (TOMMORROW): a prognostic biomarker study and a phase 3, randomised, double-blind, placebo-controlled trial.吡格列酮延迟阿尔茨海默病高危人群认知障碍的安全性和有效性（TOMMORROW）：一项预后生物标志物研究和 3 期、随机、双盲、安慰剂对照试验。
Lancet Neurol. 2021 Jul;20(7):537-547. doi: 10.1016/S1474-4422(21)00043-0.
9
Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial.PBT2靶向β淀粉样蛋白作为阿尔茨海默病修饰疗法的安全性、有效性及生物标志物研究结果：一项IIa期、双盲、随机、安慰剂对照试验
Lancet Neurol. 2008 Sep;7(9):779-86. doi: 10.1016/S1474-4422(08)70167-4. Epub 2008 Jul 30.
10
Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease.评价新型磷酸二酯酶 9 抑制剂 BI 409306 口服制剂在伴有前驱期和轻度阿尔茨海默病的患者中进行的两项随机对照 2 期研究中的疗效、安全性和耐受性。
Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

引用本文的文献

1
Exploring the Emerging Role of Stem Cell Therapy in Neurodegenerative Diseases and Spinal Cord Injury: A Narrative Review.探索干细胞疗法在神经退行性疾病和脊髓损伤中的新兴作用：一项叙述性综述
Cureus. 2025 Aug 8;17(8):e89629. doi: 10.7759/cureus.89629. eCollection 2025 Aug.
2
Therapeutic Effects of Neuro-Cells on Amyloid Pathology, BDNF Levels, and Insulin Signalling in APPswe/PSd1E9 Mice.神经细胞对APPswe/PSd1E9小鼠淀粉样病理、脑源性神经营养因子水平及胰岛素信号传导的治疗作用
Cells. 2025 Aug 20;14(16):1293. doi: 10.3390/cells14161293.
3
Neuro-Cells Mitigate Amyloid Plaque Formation and Behavioral Deficits in the APPswe/PS1dE9 Model of Alzheimer Disease While Also Reducing IL-6 Production in Human Monocytes.

本文引用的文献

1
The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty.一项评估 Lomecel-B 在衰弱老年人中的安全性和疗效的 2b 期、随机、双盲、安慰剂对照试验的设计和原理。
J Frailty Aging. 2022;11(2):214-223. doi: 10.14283/jfa.2022.2.
2
Role of Interleukin-6 in Vascular Health and Disease.白细胞介素-6在血管健康与疾病中的作用。
Front Mol Biosci. 2021 Mar 16;8:641734. doi: 10.3389/fmolb.2021.641734. eCollection 2021.
3
Intravenous administration of mesenchymal stem cells reduces Tau phosphorylation and inflammation in the 3xTg-AD mouse model of Alzheimer's disease.
神经细胞可减轻阿尔茨海默病APPswe/PS1dE9模型中的淀粉样斑块形成和行为缺陷，同时还能减少人类单核细胞中的白细胞介素-6生成。
Cells. 2025 Jul 29;14(15):1168. doi: 10.3390/cells14151168.
4
Recent progress in stem cell and immune cell-based interventions for aging and age-related disorders.基于干细胞和免疫细胞的衰老及年龄相关疾病干预措施的最新进展。
Front Aging. 2025 Jul 22;6:1638168. doi: 10.3389/fragi.2025.1638168. eCollection 2025.
5
Adaptive immunity in the neuroinflammation of Alzheimer's disease.阿尔茨海默病神经炎症中的适应性免疫。
Chin Med J (Engl). 2025 Sep 5;138(17):2116-2129. doi: 10.1097/CM9.0000000000003695. Epub 2025 Aug 5.
6
CRISPR/Cas9 and iPSC-Based Therapeutic Approaches in Alzheimer's Disease.基于CRISPR/Cas9和诱导多能干细胞的阿尔茨海默病治疗方法
Antioxidants (Basel). 2025 Jun 25;14(7):781. doi: 10.3390/antiox14070781.
7
Signs of Alzheimer's Disease: Tied to Aging.阿尔茨海默病的迹象：与衰老相关。
Int J Mol Sci. 2025 May 22;26(11):4974. doi: 10.3390/ijms26114974.
8
Stem cell therapy use in patients with dementia: a systematic review.干细胞疗法在痴呆患者中的应用：一项系统综述。
Int J Emerg Med. 2025 May 12;18(1):95. doi: 10.1186/s12245-025-00876-6.
9
Neurologists' approaches and challenges in managing early-stage Alzheimer's disease: A survey of clinical practices.神经科医生在早期阿尔茨海默病管理中的方法与挑战：临床实践调查
Bioinformation. 2024 Dec 31;20(12):1954-1958. doi: 10.6026/9732063002001954. eCollection 2024.
10
Amyloid-β-regulated gene circuits for programmable Alzheimer's disease therapy.用于可编程阿尔茨海默病治疗的β-淀粉样蛋白调节基因回路
bioRxiv. 2025 Mar 14:2025.03.12.642808. doi: 10.1101/2025.03.12.642808.
静脉注射间充质干细胞可减少阿尔茨海默病 3xTg-AD 小鼠模型中的 Tau 磷酸化和炎症。
Exp Neurol. 2021 Jul;341:113706. doi: 10.1016/j.expneurol.2021.113706. Epub 2021 Mar 20.
4
Microvascular Alterations in Alzheimer's Disease.阿尔茨海默病中的微血管改变
Front Cell Neurosci. 2021 Jan 18;14:618986. doi: 10.3389/fncel.2020.618986. eCollection 2020.
5
The Regulatory Role of IL-10 in Neurodegenerative Diseases.IL-10 在神经退行性疾病中的调节作用。
Biomolecules. 2020 Jul 9;10(7):1017. doi: 10.3390/biom10071017.
6
The IL-2 - IL-2 receptor pathway in health and disease: The role of the soluble IL-2 receptor.IL-2 - IL-2 受体通路在健康和疾病中的作用：可溶性 IL-2 受体的作用。
Clin Immunol. 2020 Sep;218:108515. doi: 10.1016/j.clim.2020.108515. Epub 2020 Jul 1.
7
Transplantation of bone marrow mesenchymal stem cells improves cognitive deficits and alleviates neuropathology in animal models of Alzheimer's disease: a meta-analytic review on potential mechanisms.骨髓间充质干细胞移植改善阿尔茨海默病动物模型的认知缺陷并减轻神经病理学：潜在机制的荟萃分析综述。
Transl Neurodegener. 2020 May 27;9(1):20. doi: 10.1186/s40035-020-00199-x.
8
An Integrated View on Vascular Dysfunction in Alzheimer's Disease.阿尔茨海默病中血管功能障碍的综合观点。
Neurodegener Dis. 2019;19(3-4):109-127. doi: 10.1159/000505625. Epub 2020 Feb 14.
9
Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis.血管内注射间充质基质细胞的细胞治疗持续显示出安全性：一项更新的系统评价和荟萃分析。
EClinicalMedicine. 2020 Jan 17;19:100249. doi: 10.1016/j.eclinm.2019.100249. eCollection 2020 Feb.
10
Mesenchymal stem cell perspective: cell biology to clinical progress.间充质干细胞展望：从细胞生物学到临床进展
NPJ Regen Med. 2019 Dec 2;4:22. doi: 10.1038/s41536-019-0083-6. eCollection 2019.