A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis

The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis.
This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.

开始日期2020-11-10

申办/合作机构

The Cleveland Clinic Foundation

[+1]

NCT04548583

/ Unknown status临床1/2期IIT

A Phase IB/IIA Study of Remestemcel-L, an Ex-vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product for the Treatment of Medically Refractory Crohn's Colitis

Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal colectomy for symptom control. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory Crohn's colitis.

开始日期2020-11-04

申办/合作机构

The Cleveland Clinic Foundation

[+1]

NCT04371393

/ Terminated临床3期IIT

Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome

The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS.
The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

开始日期2020-04-30

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+2]

100 项与瑞昂西尔相关的临床结果

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100 项与瑞昂西尔相关的转化医学

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100 项与瑞昂西尔相关的专利（医药）

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项与瑞昂西尔相关的文献（医药）

2024-01-01·Blood cell therapy

Efficacy of off-the-shelf bone marrow mesenchymal stem cells for pediatric steroid-refractory acute graft-versus-host disease

Article

作者: Mori, Makiko ; Kubota, Hirohito ; Ishikawa, Takahiro ; Oshima, Koichi ; Koh, Katsuyoshi ; Mizushima, Yoshitaka ; Mitani, Yuichi ; Kaneko, Ryota ; Honda, Mamoru ; Irikura, Tomoya ; Watakabe, Mai ; Fukuoka, Kohei ; Arakawa, Yuki

Introduction:

Temcell is a mesenchymal stem cell (MSC) product approved for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in Japan. However, reports regarding Temcell's efficacy in pediatric patients have been scarce, and the appropriate use of MSC therapy against pediatric SR-aGVHD also remains to be determined.

Patients and Methods:

We retrospectively assessed a cohort of pediatric patients treated with Temcell for SR-aGVHD following allogeneic hematopoietic transplantation. MSCs were infused intravenously at a dose of 2 × 10⁶ cells/kg according to the manufacturer's instructions.

Results:

Twelve patients received eighteen cycles of MSC therapy (median age, 10.3 [1.7-17.8] years), with four receiving additional cycles (one cycle: n = 3, three cycles: n = 1). The severity of aGVHD before MSC therapy was grade I-II in three patients and grade III-IV in nine patients (gut stage 3-4, n= 7; liver stage 3-4; n =2). The median number of immunosuppressive therapy regimens received prior to MSC administration was two (range: 1-5). The first MSC cycle displayed the best overall response rate of 83%, including six patients with a complete response (CR) and with a 49% reduction in the mean daily dose of prednisone after eight weeks. The median time to first response was 3.5 days (range: 2-15 days). Two of the four patients who were re-administered MSCs for recurrent or persistent GVHD achieved a CR. The three-year overall survival rate was 69.4%, while the three-year failure free survival (FFS) rate was 22.2%, with a median FFS of 4.9 months. There were no observable side effects of MSC therapy.

Conclusions:

MSC therapy appears to be an effective and safe treatment for pediatric SR-aGVHD, with a steroid-sparing effect and satisfactory efficacy upon re-administration. Further studies are needed to determine its appropriate combination with additional treatments and the optimal use of re-administration of MSCs.

2023-01-01·Advances in experimental medicine and biology

Illustrative Potency Assay Examples from Approved Therapies.

Article

作者: Torrents, Sílvia ; Grau-Vorster, Marta ; Vives, Joaquim

Advanced therapy medicinal products (ATMP) encompass a new type of drugs resulting from the manipulation of genes, cells, and tissues to generate innovative medicinal entities with tailored pharmaceutical activity. Definition of suitable potency tests for product release are challenging in this context, in which the active ingredient is composed of living cells and the mechanism of action often is poorly understood. In this chapter, we present and discuss actual potency assays used for the release of representative commercial ATMP from each category of products (namely, KYMRIAH^® (tisagenlecleucel), Holoclar^® (limbal epithelial stem cells), and PROCHYMAL^®/RYONCIL™ (remestemcel-L)). We also examine concerns related to the biological relevance of selected potency assays and challenges ahead for harmonization and broader implementation in compliance with current quality standards and regulatory guidelines.

2022-11-01·Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

A phase IB/IIA study of remestemcel‐L, an allogeneic bone marrow‐derived mesenchymal stem cell product, for the treatment of medically refractory ulcerative colitis: an interim analysis

Article

作者: Ream, Justin ; Dadgar, Neda ; Khaitan, Neha ; Fulmer, Clifton ; Nachand, Douglas ; Steele, Scott R. ; Elliott, Kavita ; Lightner, Amy L. ; Matyas, Caroline

Abstract:

Aim:

There have been no studies into the direct injection of mesenchymal stem cells (MSCs) for luminal ulcerative colitis (UC). Our aim was to investigate the efficacy of MSCs delivered locally via endoscopic delivery, as is done in the setting of perianal disease, to treat the local site of inflammation directly.

Method:

A phase IB/IIA randomized control clinical trial of remestemcel‐L, an ex vivo expanded allogeneic bone marrow‐derived MSC product, at a dose of 150 million MSCs versus placebo (2:1 fashion) delivered via direct injection using a 23‐gauge sclerotherapy needle at the time of colonoscopy was designed to assess the safety and efficacy of endoscopic delivery of MSCs for UC. The main outcome measures were adverse events, Mayo score and Mayo endoscopic severity score at 2 weeks, 6 weeks and 3 months post‐MSC delivery.

Results:

Six patients were enrolled and treated; four received MSCs and two placebo. All had been on prior anti‐tumour necrosis factor or anti‐integrin therapy. There were no adverse events related to MSCs. In the treatment group (n = 4), the Mayo endoscopic severity score decreased in all patients by 2 weeks after MSC delivery. At 3 months, all patients were extremely satisfied or satisfied with their MSC treatment based on the inflammatory bowel disease patient‐reported treatment impact (IBD‐PRTI), and treatment response was described as excellent or good in all patients. In the control group (n = 2), the Mayo endoscopic severity score did not increase as a result of being off alternative therapy. At 3 months, patients were dissatisfied according to the IBD‐PRTI, and treatment response was poor or unchanged.

Conclusion:

MSCs may offer a safe therapeutic option for the treatment of medically refractory UC. Early data suggest improved clinical and endoscopic scores by 2 weeks after MSC delivery.

203

项与瑞昂西尔相关的新闻（医药）

2025-07-12

·同写意

MSC的现状与未来

同写意年度巨献！！7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！2024年12月以来，中美终于各自有一款治疗GvHD的MSC药物获批上市了。MSC的产业化就此进入坦途了吗？TONACEA01理论认识的进步起初，我们对于MSC的疗效的理解是：干细胞可以自我复制并分化成为其他类型的细胞，从而参与组织器官的修复。然而，大量的研究发现：MSC回输之后，绝大多数细胞会在1天内清除，只有少量的细胞可以留存一周左右。并且MSC具有显著的免疫调节能力。于是， MSC 成为了一种通过免疫调节和旁分泌作用，诱导受损组织原位再生的“催化”细胞。以至于学界有一种声音，建议将Mesenchymal stem cell 更名为 Mesenchymal stromal cell。更激进的建议是，更名为Medicinal signalling cell。关于MSC的发展与更名，在学界引起了一场争论。这场国际学界的隔空争论的背景是：• 美国有300多家公司/诊所，在推销干细胞疗法。其中半数涉及MSC。• 人类细胞图谱计划等现代分析技术显示：所谓的MSC实际上是多种细胞的混合群体。• 很多公司未能保证cGMP的生产标准。细胞批次间的差异非常大。上述情况，确属事实。MSC细胞群体混杂，不同公司的质量发行标准，以及批次间差异大的问题，估计已经在美国造成了不少乱象。特别是考虑到MSC细胞直径大于毛细血管。正常的MSC固然可以通过变形归巢离开。而异常的MSC，特别是黏附成团的细胞，将造成血管栓塞的风险。在脑血管中，就相当于微中风。在肺脏中，就有可能肺栓塞。给小鼠做过MSC回输实验的小伙伴，应该都有概率遇见过这种情况。然而，另一方面，20多年来对MSC的基础研究与临床实验所积累的经验，也不能全盘否定。大家的确都看到过阳性疗效的神奇案例。上述情况，困扰的不仅是学界。FDA也同样在关注并介入：这封Warning Letter 是FDA在2024年12月发出的。正是FDA批准Mesoblast的MSC(Ryoncil)上市的同时。由于MSC是一个混杂的细胞群体。规范与放行并重，恐怕是监管层最合理的选择。TONACEA02GvHD的成功不可复制中国MSC的探索、实践与乱象，一点儿也不逊于美国。只是大家公开讨论得很少。2025年1月NMPA也批准了中国的第一款MSC药物艾米迈托赛注射液上市。适应症也是GvHD。我们赵老师早在2005年进入临床1期的MSC新药，其选定的适应症也是GvHD。但是很遗憾，通过GvHD这个适应症，再批一款MSC药物的道路，恐怕是难度陡增。根据CDE在2024年1月发布的《间充质干细胞防治移植物抗宿主病临床试验技术指导原则》：“目前我国已批准 JAK1/2 抑制剂用于治疗糖皮质激素或其他系统治疗应答不充分的 12 岁及以上 aGvHD 患者,ROCK2 抑制剂用于治疗糖皮质激素或其他系统治疗应答不充分的 12 岁及以上 12 cGvHD 患者,MSCs 在该人群中开展临床研究时,有必要通过合理的对照设计和研究假设,观察 MSCs 相对于现有推荐治疗的临床优势。”JAK抑制剂作为aGvHD的二线用药，起效比MSC快，作用机制比MSC更加直接强力。而MSC的特点是作用综合、柔和。因此，很难从临床研究中，观察到MSC相对于JAK抑制剂的优势。如果我们回到艾米迈托赛的注册临床，可以发现：它的临床设计是禁止实验组和对照组使用JAK抑制剂的。这样才达到了主要临床终点。同样Mesoblast的那款MSC的临床方案中，也同样排除了JAK抑制剂的使用。根据新的技术指导原则，后来者不能再这样做了。通过aGvHD，快速再批一款MSC药物的道路，基本上被堵死了。TONACEA03临床研究的经验积累死卷抄作业没有用。后面的人还要做MSC，就要拼各自的专业能力，去开辟全新的战场了。我们看一看那些未获成功的MSC临床研究，能为我们提供哪些启示吧。>>>>失败模式深度分析1. 试验设计层面• 样本量不足：多数II期试验仅20-100例，统计功效不足• 终点选择不当：采用结构性或短期终点时，MSC慢性修复优势难以体现• 患者选择过宽：缺乏基于生物标志物的精准分层2. 细胞产品层面• 剂量/频次探索不足：单次给药可能低估多剂量优势• 递送方式限制：细胞归巢效率差异大• 质量控制问题：批次间差异影响疗效一致性3. 疾病特征层面• 病理阶段过晚：器官不可逆损伤时MSC难发挥修复作用• 疾病异质性：同一疾病不同亚型对MSC反应差异大>>>>整体安全性记录• 优秀的安全特征：所有主要MSC产品均显示良好耐受性• 长期安全性： 24-36个月随访未发现肿瘤风险增加• 免疫安全性：无严重免疫反应或GVHD报告>>>>中美监管当局的态度美国FDA• 影响：监管趋严，CMC标准提高• 典型案例：多项试验因CMC要求暂停中国NMPA• 影响： 2025年新指南要求II期对照设计• 典型案例：部分试验需重新设计TONACEA04展望未来之路1、考虑MSC是一混杂细胞群体的现实。企业应该在CD73、CD90、CD105这三个基本的共性标志物之外，更加严格的定义自己所使用的细胞群体。以此来更好降低批间差，实现更好的疗效一致性。2025年ISCT针对MSC的最新共识，也反映了这一趋势。因为，A家的MSC和B家的MSC很可能不是一样的东西。2、Medicinal signalling cell 这个名字可能反映了MSC更有前景的未来！我们可以把MSC细胞作为一个智能载体。依靠AI辅助（合成生物学），使用基因编辑技术，我们可以对MSC加以改造，将特定的程序导入这个智能载体中去，让它作为纳米机器人，更好的解决组织修复、再生与抗衰老的问题。这个未来看着很遥远。往前走着走着，它也许就来了。会挽雕弓如满月，西北望，射天狼！

临床1期上市批准细胞疗法免疫疗法

2025-07-08

·研发客

中国iPSC疗法融资首超T细胞

// •中国iPSC疗法公司今年上半年总募资额约7200万美元；•iPSC技术可以克服T细胞、NK细胞和间充质干细胞等原代细胞治疗的局限性；•目前全球至少有155项iPSC疗法的临床试验正在进行；•目前国内关于细胞治疗最为实质性的法规是《海南自由贸易港博鳌乐城国际医疗旅游先行区生物医学新技术促进规定》。2025年过半，截止至6月30日，中国iPSC（诱导多能干细胞）疗法公司今年共有9家获得融资，总募资额约7200万美元，超过同期T细胞疗法（包括CAR-T和TCR-T疗法等）公司融资总额（约4100万美元）。这也是近年来，iPSC疗法公司的融资额首次超过T细胞疗法公司（见下图）。有望成为规模化和低成本的治疗方案iPSC 技术由日本京都大学的山中伸弥（Shinya Yamanaka）与高桥和利（Kazutoshi Takahashi）于 2006 年首创，山中伸弥因此与约翰·格登爵士（Sir John Gurdon）共同获得了 2012 年诺贝尔奖。基于iPSC技术的细胞治疗正成为再生医学的一个前沿方向，它可以克服T细胞、NK细胞和间充质干细胞等原代细胞治疗的局限性。例如，一些类型的细胞如神经元无法直接采集用于移植。此外，原代细胞的质量可能会受到疾病或种系突变的影响，表现出异质性。而iPSC技术可以用来克服这些限制，因为iPSC可进行基因工程改造、克隆扩增，并分化为多数体细胞类型。且与胚胎干细胞相比，iPSC来源于体细胞，因而在伦理方面受到的限制更少。异种移植实验已证明，iPSC技术可用于获取难以获得的细胞类型，可以改善疾病相关的组织功能障碍，并恢复体内稳态。据BioInformant，目前全球已经至少有155项iPSC疗法的临床试验正在进行。尚无产品获批CAR-T疗法已经在急性淋巴细胞白血病和大B细胞淋巴瘤上取得商业化成功，而iPSC领域则是另一派光景：由于迄今为止尚无产品获批，因此融资规模偏小；大型交易有限，主要集中在临床开发合作上。据BioInformant报告，2021~2024年，iPSC领域共获得风险投资约34.2亿美元，其中2021年最高，为21.5亿美元（见下图）。商业化曙光相对于CAR-T疗法， iPSC具有成本低、可规模化生产、现成使用、治疗疾病广泛等优点。目前，异体iPSC产品的开发进展显著领先于自体疗法。不过，iPSC疗法仍处在研发阶段的早期，且在监管和生产上面临一些挑战（见下表）。不过，商业化的曙光已经到来，干细胞产品近期在中美都有了商业化突破。去年底，在两次被拒后，Mesoblast的间充质基质细胞（MSC）疗法Ryoncil终于获得了美国FDA的批准，成为该机构批准的首个干细胞治疗。今年1月，中国国家药监局附条件批准铂生卓越生的MSC疗法艾米迈托赛注射液，该药成为中国首款获批上市的干细胞疗法。这两款药物都用于急性移植物抗宿主病（aGVHD）的治疗。相对于技术较为成熟的MSC，iPSC的潜力更大，应用更广泛。一旦监管和生产的瓶颈突破，未来可以在相对成本较低的情况下用于治疗多种疾病，特别是慢性疾病，如：癌症、糖尿病、神经退行性疾病、眼科以及多种免疫炎症疾病等。而近年来，国家和各地方政府在干细胞技术方面出台了多项扶持措施。去年2月，新修订的《产业结构调整指导目录》将细胞治疗药物、细胞培养列入鼓励类产业目录。5月，北京药监局核发了全国首张干细胞《药物生产许可证》。12月，《海南自由贸易港博鳌乐城国际医疗旅游先行区生物医学新技术促进规定》正式发布，这是目前国内关于细胞治疗最为实质性的法规。之后海南先后公布了两批生物医学新技术转化应用实施目录，其中包括多项干细胞治疗。刚刚过去的6月10日，中国国家药监局CDE发布《先进治疗药品的范围、归类和释义(征求意见稿)》，首次明确我国“先进治疗药品（ATMP）”分为细胞治疗药品（CTMP）、基因治疗药品（GTMPs）及其他类，为干细胞药物的注册申报与市场准入建立清晰的分类框架。而iPSC很可能成为干细胞技术落地的下一个风口。编辑 | 姚嘉yao.jia@PharmaDJ.com总第2496期访问研发客网站，深度报道和每日新闻抢鲜看www.PharmaDJ.com

细胞疗法免疫疗法ASH会议临床申请

2025-07-01

·GlobeNewswire-Health Care

Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure

NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation. In follow-up to the successful Type B meeting in early 2024 under the existing Regenerative Medicine Advanced Therapy (RMAT) designation for REVASCOR in end-stage HFrEF patients with a left ventricular assist device (LVAD), where FDA stated that the results of the presented studies could support accelerated approval, Mesoblast met with FDA on June 3, 2025 to align on key items for BLA filing. FDA provided formal minutes to the company following the most recent Type B meeting. The minutes confirm alignment with FDA on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. Mesoblast intends to file by the end of the year for accelerated approval in patients with end-stage ischemic HFrEF implanted with an LVAD. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast’s RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Allison Worldwide Emma Neal T: +1 603 545 4843 E: emma.neal@allisonworldwide.com Media – Australia BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@bluedot.net.au

细胞疗法加速审批上市批准临床研究免疫疗法

100 项与瑞昂西尔相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
类固醇难治性移植物抗宿主病	美国	Mesoblast, Inc.	2024-12-18
移植物抗宿主病	加拿大	Mesoblast Ltd.	2014-05-02

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性移植物抗宿主病	申请上市	美国	Mesoblast Ltd.	-
呼吸窘迫综合征	临床3期	澳大利亚	Mesoblast Ltd.	2023-02-01
新型冠状病毒感染	临床3期	美国	Mesoblast, Inc.	2020-04-30
急性呼吸窘迫综合征	临床3期	美国	Mesoblast, Inc.	2020-04-30
克罗恩病	临床3期	美国	Mesoblast, Inc.	2007-09-17
克罗恩病	临床3期	澳大利亚	Mesoblast, Inc.	2007-09-17
克罗恩病	临床3期	加拿大	Mesoblast, Inc.	2007-09-17
克罗恩病	临床3期	新西兰	Mesoblast, Inc.	2007-09-17
急性放射综合征	临床3期	美国	Osiris Therapeutics, Inc.	-
肠易激综合征	临床2期	澳大利亚	Mesoblast Ltd.	2023-02-01

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临床结果

适应症

分期

评价

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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


NCT02336230 (MSB-GVHD001, FDA_CBER) 人工标引	临床3期	类固醇难治性移植物抗宿主病	54	RYONCIL 2 x 10^6 MSCs/kg	淵夢壓淵淵鑰積膚遞膚(鹹襯衊衊憲顧鬱鏇醖糧) = 淵窪鏇襯積構遞膚壓鏇遞壓鬱鏇簾繭齋壓獵簾 (鬱鹹鑰製廠遞廠積鬱艱, 56.4 ~ 82.0) 更多	积极	2024-12-19
NCT04543994 (Pubmed) 人工标引	临床1/2期	溃疡性结肠炎	6	remestemcel-L	製遞憲鹹願構衊積夢廠(廠鬱繭艱窪願夢築鑰鏇) = There were no adverse events related to MSCs. 製積範餘繭憲製繭範壓 (衊鹹艱糧憲選簾餘鬱壓 ) 更多	积极	2022-06-29
NCT04543994 (Pubmed) 人工标引	临床1/2期	溃疡性结肠炎	6	Placebo		积极	2022-06-29
NCT04548583 (Pubmed) 人工标引	临床1/2期	克罗恩病	6	Remestemcel-L	壓壓鏇遞願鹽淵壓憲壓(糧製窪積觸構構醖獵餘) = 餘鏇觸鹹願觸蓋鏇窪壓淵艱窪觸築窪齋衊鹽遞 (鑰鏇鹽顧膚願顧鏇網鏇 )	积极	2022-06-17
NCT04548583 (Pubmed) 人工标引	临床1/2期	克罗恩病	6	Placebo	-	积极	2022-06-17
NCT02336230 (MSB-GVHD001 \| phase 3 \| not available \| Phase 3 Single-Arm, CTgov)	临床3期	急性移植物抗宿主病	55	remestemcel-L	範範鹽糧齋齋願鏇網鹽 = 簾糧選構淵壓鬱獵鬱餘廠觸構衊鹹鬱艱餘鑰淵 (醖繭襯願糧簾艱壓願簾, 選構憲獵夢築製夢壓艱 ~ 鏇構糧鏇廠壓簾醖顧衊) 更多	-	2022-03-17
NCT02652130 (CTgov)	临床3期	急性移植物抗宿主病	32	Remestemcel-L	餘網淵遞簾衊網廠製廠 = 廠廠顧觸遞鹽願築簾獵壓鬱網願淵膚憲糧鑰獵 (淵夢憲網繭觸構鹽構窪, 願網廠淵壓壓築壓夢繭 ~ 構網願觸築窪選鑰簾淵) 更多	-	2022-03-16
NCT04371393 (GlobeNewswire) 人工标引	临床3期	新型冠状病毒感染	217	Remestemcel-L	膚鹽鑰襯鑰製齋壓蓋蓋(鹽築構膚鹽糧鹹網簾膚) = 簾餘醖獵簾衊範窪顧網蓋蓋積齋範範觸糧鬱選 (夢簾糧餘獵遞繭製遞願 )	积极	2021-04-29
NCT04371393 (GlobeNewswire) 人工标引	临床3期	新型冠状病毒感染	217	standard of care	-	积极	2021-04-29
NCT02336230 \| NCT00759018 \| NCT00366145 (Tandem Meetings ASTCT and CIBMTR2021)	临床3期	难治性急性移植物抗宿主病一线 \| 二线	309	Remestemcel-L	餘膚製積醖顧遞廠簾糧(衊鑰齋糧艱膚蓋淵積壓) = 膚製鑰餘獵選鬱憲醖顧觸簾窪窪淵鏇窪鑰築壓 (醖築膚遞觸衊鹽衊膚簾 )	积极	2021-03-01
NCT02336230 \| NCT00759018 \| NCT00366145 (Tandem Meetings ASTCT and CIBMTR2021)	临床3期	类固醇难治性移植物抗宿主病一线	309	Remestemcel-L	簾艱壓艱壓糧憲獵觸鑰(繭觸衊鹹蓋襯廠醖壓窪) = 糧醖積醖選夢鹹廠夢繭選構鑰積鏇壓獵餘廠窪 (簾鹽積網膚範醖簾構網 ) 更多	积极	2021-03-01
NCT02336230 (phase 3, Tandem Meetings ASTCT and CIBMTR2021)	临床3期	类固醇难治性移植物抗宿主病	54	Remestemcel-L inpatient	膚鹹鏇壓蓋夢淵壓願糧(窪夢艱鹹糧顧窪獵鹽簾) = 獵遞壓艱齋鹽觸糧積壓範鹽築艱憲鹽窪築鏇網 (鬱範蓋鬱艱築壓齋窪衊 ) 更多	积极	2021-03-01
NCT02336230 (phase 3, Tandem Meetings ASTCT and CIBMTR2021)	临床3期	类固醇难治性移植物抗宿主病	54	Remestemcel-L inpatient + outpatient	膚鹹鏇壓蓋夢淵壓願糧(窪夢艱鹹糧顧窪獵鹽簾) = 範顧網醖構積觸鹹獵鏇範鹽築艱憲鹽窪築鏇網 (鬱範蓋鬱艱築壓齋窪衊 ) 更多	积极	2021-03-01
NCT02336230 (not available, Tandem Meetings ASTCT and CIBMTR2021)	临床3期	类固醇难治性移植物抗宿主病 T and B lymphocytes \| soluble suppression of tumorigenicity 2 (ST2)	40	Remestemcel-L	獵範廠願蓋顧襯遞淵餘(網繭壓齋醖壓醖網襯襯) = 憲鹽遞願餘艱築蓋鏇醖觸糧獵網壓醖淵鏇繭窪 (衊壓衊壓齋膚範襯襯鏇, [22.02 ~ 31.06]) 更多	积极	2021-03-01