Mesenchymal stem cell (MSC) therapy is among the promising treatments for acute respiratory distress syndrome (ARDS). Our study aimed to investigate the clinical efficacy of MSC treatment in COVID-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to prognosis.

开始日期2022-01-01

申办/合作机构-

100 项与 ADR-001 相关的临床结果

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100 项与 ADR-001 相关的转化医学

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100 项与 ADR-001 相关的专利（医药）

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项与 ADR-001 相关的文献（医药）

2024-11-01·Kidney360

Safety and Tolerability of Adipose-Derived Mesenchymal Stem Cell (ADR-001) Therapy for IgA Nephropathy

Article

作者: Naruse, Tomohiko ; Kosugi, Tomoki ; Kuwatsuka, Yachiyo ; Ishimoto, Takuji ; Horinouchi, Asuka ; Tanaka, Akihito ; Kato, Noritoshi ; Maruyama, Shoichi ; Nakai, Yasuhiro ; Fujieda, Kumiko ; Saito, Shoji ; Saka, Yosuke ; Kinoshita, Fumie ; Furuhashi, Kazuhiro ; Maeda, Kayaho ; Mimura, Tetsushi

Key Points:

IgA nephropathy often requires KRT.Mesenchymal stem cells offer clinical benefits.Adipose-derived mesenchymal stem cells are safe and tolerable.

Background:

IgA nephropathy (IgAN) often requires KRT because of its refractoriness and because corticosteroids pose infection risks. However, mesenchymal stem cells offer clinical benefits because of their regenerative and immunomodulatory properties. This prospective clinical trial assessed the safety and tolerability of adipose-derived mesenchymal stem cell (ASC) therapy and evaluated its therapeutic efficacy.

Methods:

This phase 1 study included adult patients with refractory IgAN that was difficult to treat with traditional therapies. ASC therapy comprising one intravenous dose of 1×108 cells was administered to three to six patients in Cohort 1. The same intravenous dose was administered twice with a 2-week interval to six patients in Cohort 2. Heparin was administered simultaneously. This study continued for 52 weeks, and the primary end points were safety and tolerability during the 6-week period after treatment administration. Secondary end points included adverse events and efficacy measures such as clinical remission, partial remission, urine protein remission, hematuria remission, time to remission, changes in the urine protein and hematuria levels, and changes in the eGFR.

Results:

The three patients in Cohort 1 and six patients in Cohort 2 who received ASC therapy achieved the primary end points. No severe adverse clinical events were observed. Therefore, the safety and tolerability of ASCs were confirmed. Improvements, such as significantly decreased kidney damage markers and urinary protein levels, were observed immediately after ASC administration.

Conclusions:

The safety and tolerability of ASCs are acceptable for patients with IgAN.

Clinical Trial registry name and registration number::

This trial was registered with the Japan Registry of Clinical Trials (jRCT2043200002; registration date: April 14, 2020) and ClinicalTrials.gov (NCT04342325; registration date: April 13, 2020).

Frontiers in medicine

Protocol for a Phase 1, Open-Label, Multiple-Center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 in the Treatment of Immunoglobulin A Nephropathy

Article

作者: Kayaho Maeda ; Tomoki Kosugi ; Kazuhiro Furuhashi ; Shoichi Maruyama ; Shinobu Shimizu ; Fumie Kinoshita ; Yasuhiro Nakai ; Akihito Tanaka ; Takuji Ishimoto ; Tetsushi Mimura ; Tomohiko Naruse ; Yachiyo Kuwatsuka ; Kumiko Fujieda ; Shoji Saito ; Yosuke Saka

Introduction:

Immunoglobulin A (IgA) nephropathy is a disease that presents with urinary symptoms such as glomerular hematuria and urinary protein positivity, with predominant deposition of IgA in the mesangial region of the glomerulus. Corticosteroids are mainly used for treatment; however, infection is a serious adverse event, and evidence regarding therapeutic efficacy is insufficient, thus new treatments are strongly desired. Mesenchymal stem cells (MSCs) contribute to the amelioration of inflammation and recovery of organ function in inflammatory environments by converting the character of leukocytes from inflammatory to anti-inflammatory and inducing the proliferation and differentiation of organ component cells, respectively. These properties of MSCs have led to their clinical application in various inflammatory diseases, but this study is the first clinical trial of MSCs for refractory glomerulonephritis in the world. This study is registered and assigned the number, jRCT2043200002 and NCT04342325.

Methods:

This will be a phase 1, open-label, multiple-center, dose-escalation study of adult patients with refractory IgA nephropathy resistant to or difficult to treat with existing therapies. ADR-001 will be administered intravenously to from three to six patients at a dose of 1 × 108 cells once in the first cohort and to six patients twice at 2-week intervals in the second cohort, and observation will continue until 52 weeks. The primary endpoint will be the evaluation of adverse events up to 6 weeks after the start of ADR-001 administration. Secondary endpoints will be the respective percentages of patients with adverse events, clinical remission, partial remission, remission of urine protein, remission of hematuria, time to remission, changes in urine protein, hematuria, and estimated glomerular filtration rate.

Results:

Following the administration of ADR-001 to patients with IgA nephropathy, the respective percentages of patients with adverse events, asymptomatic pulmonary emboli, clinical remission, partial remission, urine protein remission, hematuria remission, their time to remission, changes in urine protein, hematuria, and glomerular filtration rate will be determined.

Conclusion:

This study will evaluate the safety and tolerability of ADR-001 and confirm its therapeutic efficacy in adult patients with refractory IgA nephropathy.

项与 ADR-001 相关的新闻（医药）

2026-06-05

·杭吉泰迪干细胞

山东第一医科大学等多机构联合发文：系统描绘全球间充质干细胞疗法的临床开发全景

干细胞具有自我更新和多向分化潜能，是再生医学的重要基础。间充质干细胞（MSCs）作为非造血成体干细胞，免疫原性低，可从自身组织（尤其是脂肪）获取，在组织再生及自身免疫病、炎症性疾病治疗中潜力巨大。尽管全球临床试验数量持续增长，但对其时间趋势、区域分布和分期特征的系统性宏观分析仍属空白。近日，山东第一医科大学皮肤病医院联合山东省皮肤病与性病研究所、山东省医学科学院、上海交通大学医学院附属第九人民医院整形外科等机构，在《Stem Cell Reviews and Reports》发表综述，系统梳理了全球MSCs疗法的临床开发现状与未来方向[1]。一、数据来源可靠，样本量充足研究团队于2025年8月18日，利用Trialtrove商业数据库（整合多个公共注册平台信息），以“药物类型：间充质干细胞”为检索词，经人工剔除重复、撤回及非干预性研究后，最终纳入416项临床试验。该数据库经专业整理，数据质量较高，为本研究提供了扎实的量化基础。二、临床试验的增长态势与阶段分布自2014年欧洲药品管理局批准首个干细胞产品Holoclar以来，全球MSCs临床试验数量显著增长，2020年达到峰值，过去十年总体呈上升趋势（图1A）。这一变化反映了国际学术界对MSCs治疗潜力的认可度不断提升。从分期构成看，I期和II期试验占据主导地位，III期试验数量稀少。这说明该领域仍处于大规模投入与早期探索阶段。在已完成试验中，相当一部分（167项，占40.14%）已结束，但其中仅51项（30.54%）报告了积极结果（图1B）。这些完成试验确实提供了安全性与有效性的直接证据，但整体转化成功率仍有较大提升空间。图1：间充质干细胞（MSCs）治疗临床试验数据的分析与分布。(A) MSCs临床试验按阶段划分的年度分布。(B) 不同阶段的临床试验分布及其状态。(C) 针对多种疾病的MSCs临床试验作用机制的堆叠柱状图。(D) MSCs临床试验中不同生物标志物的状态。(E) MSCs临床试验中涉及的生物标志物比例。(F) 试验中使用的各种药物类型。(G) 各种联合疗法的比例。(H) 全球各国分布概览图。与此同时，有156项试验（37.5%）正处于计划或进行中，显示研究热度不减。适应症高度集中于四大领域：自身免疫/炎症（含骨关节炎，130项，31.25%）、中枢神经系统疾病（115项，27.64%）、传染病（含新冠，69项，16.59%）以及代谢/内分泌疾病（含糖尿病，49项，11.78%）（图1C）。三、核心机制围绕炎症调控，生物标志物指向明确炎症通路为主导靶点：临床试验中最常作为主要终点评估的生物标志物是肿瘤坏死因子（TNF）和C反应蛋白（CRP）（图1D和E），这提示炎症或损伤反应是MSCs干预的核心环节。机制上，MSCs通过TNF-α/吲哚胺2,3-双加氧酶（IDO）轴抑制巨噬细胞功能，为组织修复营造有利的免疫微环境。在评估频次排名前九的生物标志物中，有四项的完成率超过50%。其中CRP完成率最高，而糖化血红蛋白A1c的完成率也居于前列。多通路协同调节：研究数据显示，MSCs常作为Toll样受体（TLR）拮抗剂发挥作用（44例，10.58%），通过分泌外泌体抑制靶细胞TLR信号通路，进而调节炎症介质。在研发最为深入的中枢神经系统领域，MSCs还扮演着多巴胺受体激动剂的角色。研究表明，MSCs衍生的细胞能够替代多巴胺并重建纹状体多巴胺能神经元网络，从而对神经细胞发挥保护作用。这些数据或许能够启发未来的研究人员关注MSCs疗法的免疫抑制功能，例如其强大的神经潜能和增殖能力。研究人员通常通过这两种细胞因子来追踪炎症指标。此外，研究发现MSCs能够通过IDO轴抑制巨噬细胞功能，从而创造一个有利于组织修复的环境。一项研究支持这一方向，该研究表明间充质干细胞（MSCs）可通过驱动抗炎性M2巨噬细胞极化来减轻炎症并促进破骨细胞生成。此外，MSCs参与免疫系统的机制还包括增加抗炎细胞因子IL-10的分泌和诱导活化T细胞凋亡，从而减少炎症损伤。四、单药治疗仍是主流，联合治疗刚刚起步尽管在实验中与多种标志物相关，但目前大多数疗法仍主要依赖于间充质干细胞（MSCs）单药治疗。例如，异体APZ2-ACLF、Rexlemestrocel-L、ADR-001和其他药物（图1D）。此外，已有15项临床试验研究了MSCs与其他治疗方法的联合应用。这些方法包括激素疗法、免疫疗法、注射疗法等（图1G）。其中，生物疗法（4项，26.7%）、免疫疗法（3项，20%）和激素疗法（3项，20%）的使用最为普遍，其次是化疗（2项，13.3%）。多模式联合策略探索有限，这提示联合免疫疗法可能是未来提升疗效的重要方向。五、中美观双极，亚洲领跑，产业主导明显在开展MSCs临床试验的前五大国家/地区中，亚洲占据四席。中国以114项（27.4%）（图1H）位居全球首位，美国以107项（25.72%）紧随其后，欧洲也受到较多关注。受试群体以成人及老年人为主（221项，53.1%），涉及儿童的试验因伦理与安全性考量，仍处于审慎推进阶段。从申办方来看，工业界是主导力量，学术机构次之。这表明MSCs疗法正加速从基础研究向产业化迈进。六、新兴前景与未来方向 1、深入探索旁分泌机制与外泌体疗法：MSCs的治疗效应越来越多地被归因于其分泌的多种生物活性分子（细胞因子、生长因子及细胞外囊泡/外泌体），而非直接分化替代受损组织。MSC来源的小细胞外囊泡（MSC-sEVs）作为无细胞疗法，可规避细胞存活、储存与给药等挑战，改善药理学可预测性，是极具潜力的下一代治疗工具。然而，其规模化生产仍面临关键质量属性定义不清、来源及培养条件批次间变异等技术瓶颈。 2、拓展新兴适应症：在传统优势领域之外，MSCs在多个新方向取得重要进展。抗衰老方面：2026年6月，中国启动了国家科技部重点研发计划——“脐带间充质干细胞输注改善衰老的有效性和安全性多中心随机对照研究”，纳入2000名受试者，采用国内首款获批的干细胞药品艾米迈托赛注射液（睿铂生）。国外I/II期研究已证实，静脉输注人脐带MSCs可改善衰老衰弱患者的生活质量与身体功能，并降低TNF-α及IL-17水平。阿尔茨海默病方面：一项涵盖17项临床试验的综述表明，MSCs治疗安全可行，能够通过免疫调节、清除Aβ淀粉样蛋白、抗凋亡、抗氧化及促进血管新生等多靶点机制，改善认知功能与生活质量。帕金森病方面：2026年发表于《Cureus》的综述指出，MSCs通过分泌脑源性神经营养因子（BDNF）和胶质细胞源性神经营养因子（GDNF）保护神经元，同时抑制神经炎症，推动治疗范式从“控制症状”向“修复神经”转变。肌萎缩侧索硬化方面：韩国Corestem公司的Neuronata-R®（自体骨髓MSC疗法）在III期试验整体人群中未达主要终点，但在疾病进展较慢的亚组中观察到功能与呼吸复合终点的显著改善。公司已计划以亚组数据向FDA申请加速审批，这为基于生物标志物的精准分层治疗提供了范例。 3、优化精准分层与联合治疗策略： ALS的案例提示，未来MSCs疗法的成功可能取决于对患者进行更精准的分层和个体化给药。联合治疗策略目前仍处于早期阶段（仅占3.6%），但这将是提高疗效的重要方向，尤其是MSCs与免疫疗法的协同应用。 4、推动生产标准化与质控体系建设：未来需要构建药品化的统一质量标准，积极探索结合生物材料的复合产品以及基因修饰MSCs等创新技术。同时，3D生物反应器等规模化制备平台的发展，有望攻克从研发到GMP生产的产业化瓶颈，为全球细胞治疗提供高效、合规的“中国路径”。七、综述与展望本研究系统描绘了全球MSCs疗法的临床开发全景。中国与美国构成双引擎，亚洲地区临床研究最为活跃。适应症高度集中于自身免疫/炎症、中枢神经系统及代谢性疾病，MSCs通过IDO轴、TLR拮抗等机制发挥核心免疫调节功能。然而，临床试验数量与监管批准之间的巨大落差，揭示了该领域的深层结构性挑战。III期转化率低、疗效证据不一致、早期试验设计缺陷、MSCs来源与制备工艺异质、效价评估体系缺失，以及冻存后热休克、即刻血源性炎症反应等细胞生物学问题，共同构成了制约MSCs成药性突破的核心瓶颈。参考资料： [1]：Yin, R., Jiang, X., Ao, S. et al. Clinical Development of Mesenchymal Stem Cells Therapies Worldwide: Current Landscape and Emerging Promises. Stem Cell Rev and Rep (2026). https://doi.org/10.1007/s12015-026-11166-w 免责说明：本文仅用于传播科普知识，分享行业观点，不构成任何临床诊断建议！杭吉干细胞所发布的信息不能替代医生或药剂师的专业建议。如有版权等疑问，请随时联系我。 ●818号令落地，中国CGT迎来商业化新路径--对生物技术企业意味着什么？ ●三十余款干细胞产品上市背后：干细胞疗法的前景、机制与演化脉络（上） ●三十余款干细胞产品上市背后：干细胞疗法的临床转化研究、挑战与前景与解决方案（下） ●全国三甲医院细胞治疗相关机构一览表（截至2026年5月）

2026-03-10

·为壹生物医药科技

一亿个干细胞进入体内之后：IgA肾病治疗的一次重要探索

点击上方「蓝字」，关注我们在肾脏疾病中，IgA肾病（IgA nephropathy，IgAN）是全球最常见的一类原发性肾小球肾炎。这种疾病的本质，其实是一种免疫系统“识别错误”。正常情况下，人体产生的免疫球蛋白A（IgA）主要负责保护呼吸道和消化道黏膜，但在IgA肾病患者体内，一部分异常结构的IgA会形成免疫复合物，并沉积在肾小球的系膜区域。这些沉积物就像长期存在的“炎症火种”，不断刺激局部免疫反应，导致肾小球发生慢性炎症、结构损伤以及功能下降。随着时间推移，肾脏过滤血液的能力逐渐衰退，最终可能发展为终末期肾病。这种疾病的进程往往非常漫长，但却难以逆转。研究显示，大约 50%～75%的成年患者在确诊后的20年内会出现明显的肾功能恶化，并最终需要肾透析或肾移植等肾脏替代治疗。因此，寻找新的干预手段，一直是肾脏病研究的重要方向。 01 传统治疗手段的局限目前临床上针对IgA肾病的治疗，大多围绕两个目标展开：一是减少异常IgA引发的免疫反应，二是减缓肾脏损伤的进程。在实践中，医生通常会使用糖皮质激素或其他免疫抑制剂来降低免疫反应，同时配合降压药物控制血压，以减少对肾小球的持续压力。然而，这类治疗方式存在明显局限。糖皮质激素虽然可以降低尿蛋白水平，但同时也会带来较高的不良反应风险，例如感染、代谢紊乱、骨质疏松等问题。因此，是否在所有成人IgA肾病患者中使用激素治疗，一直存在较大争议。正因为如此，研究人员开始把目光投向一种新的治疗思路——利用细胞本身的修复和免疫调节能力来干预疾病。 02 干细胞为何被寄予厚望在众多细胞治疗策略中，间充质干细胞（Mesenchymal Stem Cells，MSCs）被认为具有较大的潜力。这类细胞广泛存在于人体组织中，能够分泌多种生物活性因子，并参与组织修复和免疫调节。在实验和临床研究中，MSCs表现出几种与肾脏疾病高度相关的特性：它们能够抑制炎症反应、减少细胞凋亡，并促进血管新生，从而在一定程度上改善组织微环境。其中，脂肪来源间充质干细胞（Adipose-derived stem cells，ASCs）尤其受到关注。这类细胞来源丰富、扩增能力强，而且能够分泌多种免疫调节因子和生长因子，因此被认为是较为理想的细胞治疗候选者。 03 一项来自日本的临床试验 2024年11月，日本名古屋大学医院肾脏病研究团队在《Kidney360》期刊发表了一项临床研究，评估一种名为 ADR-001 的脂肪来源间充质干细胞疗法在IgA肾病患者中的安全性与潜在疗效。这是一项多中心、开放标签、单臂、剂量递增的一期临床试验。研究共纳入9名患者，其中7名为男性、2名为女性，平均年龄约47岁。从确诊IgA肾病到参与研究的时间中位数为6年。该前瞻性临床试验旨在评估脂肪来源间充质干细胞（ASC）治疗的安全性和耐受性，并评估其治疗疗效。在治疗方案上，研究人员设计了两种给药方式：第一组3名患者接受了一剂静脉注射ADR-001（1×108个细胞）的治疗。第二组6名患者接受了两剂静脉注射ADR-001（1×108个细胞）的治疗，间隔2周。同时所有患者在ADR-001给药前均接受1000 U肝素注射。该研究持续观察了52周。在每次给药前，所有患者都会接受肝素注射，以减少血栓风险。整个研究的随访时间为 52周。 04 安全性：最核心的观察指标对于任何新的细胞疗法来说，安全性始终是第一位的。因此，本研究的主要终点，是在治疗后6周内评估不良事件的发生情况。结果显示，在9名患者中，共有5人报告了6起不良事件，但这些事件均较轻微。其中比较常见的是D-二聚体水平升高，共有4名患者出现这一现象；另有1名患者出现接触性皮炎。值得注意的是，这些变化大多仅体现在实验室指标上，并未观察到严重的临床症状，也没有出现需要紧急处理的安全问题。整个52周的随访期间，也没有发现长期不良反应。总体来看，这些数据提示 ADR-001在IgA肾病患者中的耐受性较好。 05 肾脏损伤指标的变化除了安全性，研究人员还重点观察了几项与肾功能密切相关的指标，包括尿蛋白、血尿以及肾损伤标志物的变化。在治疗后，研究人员发现一个比较有意思的现象：患者的尿蛋白水平在给药后的第二天就出现明显下降，随后又逐渐回升至接近基线水平。这提示细胞治疗可能在早期对炎症反应产生了短暂影响。在接受两次输注的患者中，另一项肾损伤指标——**尿液L-FABP（肝型脂肪酸结合蛋白）**也出现了明显下降。L-FABP通常被视为肾小管损伤的重要标志物，其下降意味着肾脏细胞可能正在经历某种程度的恢复。至于整体肾功能指标eGFR，在研究期间变化相对平稳：治疗前平均约为 81 ml/min/1.73m²，一年后为 75 ml/min/1.73m²。 06 一个病例报告：干细胞治疗后的明显改善除了临床试验数据外，研究人员还提及了一个与IgA肾病相关的病例报告。这名患者是一位50岁男性，在一次上呼吸道感染后出现持续腰痛和不适。随后检查发现，他的肌酐水平高达 6.2 mg/dL，并伴有高血压和炎症指标升高。经过治疗和透析后，出院时肌酐仍维持在 3.0 mg/dL。 2020年3月，这名患者接受了人脐带来源间充质干细胞（hUC-MSCs）治疗，总计静脉输注约1.2亿个细胞。随访结果显示，治疗后的变化十分明显。1个月后，患者血压下降至130/80 mmHg；2个月后，肌酐水平下降至 1.03 mg/dL，已经接近正常范围；6个月随访时，血压稳定在120/80 mmHg，肌酐维持在 1.0 mg/dL。在整个治疗和随访过程中，并未观察到明显的不良反应。 07 仍处在探索阶段的治疗方向综合目前的研究结果可以看到，间充质干细胞在IgA肾病治疗中展现出一定潜力。在这项小规模临床试验中，ADR-001不仅表现出较好的安全性，还在部分患者中带来了尿蛋白和肾损伤指标的改善。不过，需要强调的是，这类研究仍然处在早期阶段。样本量较小、随访时间有限，因此还无法得出明确的疗效结论。未来仍需要更大规模、随机对照的临床试验，来进一步验证这种疗法的真实效果。但可以确定的是，在传统免疫抑制治疗之外，利用干细胞调节免疫和促进组织修复的策略，正在为慢性肾病提供一种新的研究方向。广州为壹微信号：为壹生物医药科技长按二维码关注公众号

临床结果临床1期临床2期

2023-11-09

·SYNAPSE

Hot Track in Disease Treatment: Mesenchymal Stem Cell Therapy

Mesenchymal stem cells (MSCs) have broad therapeutic potential for treating inflammation and degenerative diseases. Mesenchymal stem cells have been isolated and identified from many other sources of human tissues, widely distributed in virtually all tissues (including fetal and adult), such as bone marrow, blood, umbilical cord, placenta, fat, amnion, amniotic fluid, dental pulp, skin, menstrual blood, and so on. Mesenchymal stem cell therapy works in both direct and indirect ways. The direct actions include homing, directed differentiation, multipotent differentiation, and paracrine effects. The indirect actions involve the bidirectional regulation of immune responses and inflammation, antioxidative stress, antifibrosis, antiapoptosis, hematopoiesis support, participation in or promotion of angiogenesis, activation of the proliferation and differentiation of endogenous stem cells, and the dedifferentiation of diseased tissue organs' normal cells, as well as anti-aging, and anti-scar formation. The application of mesenchymal stem cell therapy in clinical practice is very broad, including the treatment of hematological diseases, neurological diseases, digestive diseases, cardiovascular diseases, respiratory diseases, skeletal system diseases, endocrine system diseases, immune system diseases, urogenital diseases, as well as anti-aging and immune enhancement. With the continuous investment in future scientific research, it is believed that there will be increasingly more difficult and complex diseases starting to explore the use of mesenchymal stem cells for treatment, and an increasing number of new drugs based on mesenchymal stem cells will be approved for clinical trials and even applications. Mesenchymal Stem Cell Therapy Competitive LandscapeAccording to Patsnap Synapse, as of 8 Oct 2023, there are a total of 339 Mesenchymal stem cell therapy drugs worldwide, from 320 organizations, covering 11 targets, 299 indications, and conducting 1254 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, targets, organizations, clinical trials, and clinical results related to this drug type. Phase II Clinical Trial of Mesenchymal Stem Cell Therapy Medicinal: ADR-001ADR-001 is a mesenchymal stem cell therapy drug that targets ADAR. Mesenchymal stem cells are multipotent cells that can differentiate into various cell types, including those found in the immune system, urogenital system, and digestive system. ADAR, or adenosine deaminase acting on RNA, is an enzyme involved in RNA editing. The therapeutic areas for ADR-001 include immune system diseases, urogenital diseases, and digestive system disorders. Immune system diseases encompass a wide range of conditions that affect the body's immune response, such as autoimmune diseases and immunodeficiency disorders. Urogenital diseases refer to disorders affecting the urinary and reproductive systems, including conditions like urinary tract infections and infertility. Digestive system disorders involve issues with the gastrointestinal tract, such as inflammatory bowel disease and liver diseases. The active indications for ADR-001 are liver cirrhosis, glomerulonephritis, and IGA. Liver cirrhosis is a chronic liver disease characterized by the replacement of healthy liver tissue with scar tissue, leading to impaired liver function. Glomerulonephritis is a group of kidney diseases that cause inflammation in the glomeruli, the tiny filters in the kidneys. IGA refers to immunoglobulin A, an antibody that plays a role in the immune response. Elevated levels of IGA can be associated with certain diseases, including kidney and liver disorders. Rohto Pharmaceutical Co., Ltd. is the originator organization of ADR-001. They are responsible for the development and research of this drug. The highest phase of development for ADR-001 is Phase 2, indicating that it has undergone initial testing for safety and efficacy in a limited number of patients. In summary, ADR-001 is a mesenchymal stem cell therapy drug developed by Rohto Pharmaceutical Co., Ltd. It targets ADAR and is being investigated for its potential in treating immune system diseases, urogenital diseases, and digestive system disorders. The active indications for ADR-001 include liver cirrhosis, glomerulonephritis, and IGA. Currently, ADR-001 is in Phase 2 of development, suggesting that further clinical trials are required to assess its effectiveness and safety. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Approved Mesenchymal Stem Cell Therapy Medicinal: StempeuticsMesenchymal stem cell therapies, specifically Stempeutics, are a type of drug used in the field of biomedicine. These therapies are designed to treat various medical conditions related to the digestive system, nervous system, cardiovascular system, endocrinology and metabolism, as well as skin and musculoskeletal diseases. The active indications for Stempeutics include osteoarthritis, diabetic foot, and rectal fistula. These conditions are targeted by the drug to provide therapeutic benefits and alleviate symptoms associated with them. In terms of its development stage, Stempeutics has reached the highest phase of approval, indicating that it has successfully undergone rigorous testing and evaluation. The first approval of Stempeutics was granted in August 2020 in India. This means that India was the first country/location to approve the drug for use in patients. This approval signifies that the regulatory authorities in India have reviewed the clinical data and determined that the drug meets the necessary standards for safety and effectiveness. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Overall, Stempeutics is a mesenchymal stem cell therapy that has been approved for the treatment of osteoarthritis, diabetic foot, and rectal fistula. It has shown promising results in clinical trials and has received approval in India. The drug holds potential for addressing various medical conditions related to the digestive system, nervous system, cardiovascular system, endocrinology and metabolism, as well as skin and musculoskeletal diseases.

100 项与 ADR-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床2期	日本	Rohto Pharmaceutical Co., Ltd.	2021-06-15
失代偿性肝硬化	临床2期	日本	Rohto Pharmaceutical Co., Ltd.	2017-07-20
免疫球蛋白a肾病	临床1期	日本	Rohto Pharmaceutical Co., Ltd.	2020-06-15

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02484950 (CTgov)	N/A	肩袖综合征	62	Standard arthroscopic rotator cuff repair (Rotator Cuff Repair With Stem Cells)	襯襯積獵壓製鑰艱憲餘(簾鹹獵範構鬱獵襯遞繭) = 艱遞製鹹憲餘鏇壓憲選選廠鏇觸壓艱鹹鑰鹽簾 (淵夢鬱製壓鹹繭網醖廠, 願繭壓膚鹽願艱衊製網 ~ 鹽構願築鬱鹽襯醖鑰遞) 更多	-	2025-03-06
				Standard arthroscopic rotator cuff repair (Rotator Cuff Repair Without Stem Cells)	襯襯積獵壓製鑰艱憲餘(簾鹹獵範構鬱獵襯遞繭) = 獵鬱繭餘繭構淵觸製齋選廠鏇觸壓艱鹹鑰鹽簾 (淵夢鬱製壓鹹繭網醖廠, 憲艱鑰鹹鏇選鏇網鏇網 ~ 簾獵衊鑰鏇範構繭糧齋) 更多