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更新于：2026-10-19
Remestemcel-L-rknd
瑞昂西尔
更新于：2026-10-19
概要
基本信息
药物类型 间充质干细胞疗法 |
别名 Adult Human Mesenchymal Stem Cells、hMSC Mesoblast、Human (allogeneic) bone marrow-derived mesenchymal stem cell(JCR Pharmaceuticals) + [11] |
靶点- |
作用方式- |
作用机制 细胞替代物 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2014-05-02), |
最高研发阶段(中国)- |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (美国) |
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关联
27
项与 瑞昂西尔 相关的临床试验NCT07568535
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease
NCT04543994
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
NCT04548583
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
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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28
项与 瑞昂西尔 相关的文献（医药）2025-07-01JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Remestemcel-L-rknd for Steroid-Refractory Acute Graft-vs-Host Disease in Pediatric Patients
Article
作者: Przepiorka, Donna ; Mahat, Upendra ; Fashoyin-Aje, Lola A.
This JAMA Insights discusses the FDA approval of remestemcel-L-rknd to treat graft-vs-host disease in children and provides regulatory considerations for this approval.
2024-01-01Blood 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.
2022-11-01Colorectal 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: Douglas Nachand ; Neha Khaitan ; Neda Dadgar ; Amy L. Lightner ; Clifton Fulmer ; Kavita Elliott ; Scott R. Steele ; Caroline Matyas ; Justin Ream
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.
649
项与 瑞昂西尔 相关的新闻（医药）2026-10-18
2026-10-16
2026-10-16
100 项与 瑞昂西尔 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D09719 | - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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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 | 2024-12-18 | |
| 移植物抗宿主病 | 加拿大 | 2014-05-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | - | |
| 难治性急性移植物抗宿主病 | 临床3期 | - | 2026-08-31 | |
| 呼吸窘迫综合征 | 临床3期 | 澳大利亚 | 2023-02-01 | |
| 新型冠状病毒感染 | 临床3期 | 美国 | 2020-04-30 | |
| 急性呼吸窘迫综合征 | 临床3期 | 美国 | 2020-04-30 | |
| 克罗恩病 | 临床3期 | 美国 | 2007-09-17 | |
| 克罗恩病 | 临床3期 | 澳大利亚 | 2007-09-17 | |
| 克罗恩病 | 临床3期 | 加拿大 | 2007-09-17 | |
| 克罗恩病 | 临床3期 | 新西兰 | 2007-09-17 | |
| 急性放射综合征 | 临床3期 | 美国 | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 25 | 夢餘廠鹹餘構醖醖築鬱(簾窪範壓齋鹽淵醖鹹夢) = 餘顧蓋餘淵構蓋淵艱壓 構網蓋構衊簾齋選範網 (鏇膚淵淵鹽選廠餘積醖 ) 更多 | 积极 | 2025-02-12 | |||
临床3期 | 54 | RYONCIL 2 x 10^6 MSCs/kg | 壓範襯觸繭蓋夢觸鹹壓(積顧壓壓鹽壓選廠顧範) = 獵襯繭淵餘築觸夢廠鬱 觸獵窪顧構鏇餘積鹹構 (願鬱壓繭簾廠鑰網糧願, 56.4 ~ 82.0) 更多 | 积极 | 2024-12-19 | ||
临床1/2期 | 6 | 積醖憲憲願餘憲鏇遞選(齋憲觸簾夢廠積鏇襯餘) = There were no adverse events related to MSCs. 膚糧繭夢壓餘鹽襯觸窪 (餘製觸壓簾鹹鹽積齋製 ) 更多 | 积极 | 2022-06-29 | |||
Placebo | |||||||
临床1/2期 | 6 | 鹽鑰壓鏇鹽遞觸餘膚夢(憲襯鬱憲遞築構鏇夢繭) = 鹽網鏇壓蓋衊範製顧襯 顧鬱鬱窪餘膚遞鹹齋顧 (簾窪鹽獵繭鏇醖壓醖製 ) | 积极 | 2022-06-17 | |||
Placebo | - | ||||||
临床3期 | 55 | 選壓鹹範積蓋遞獵窪觸 = 鹽夢遞淵繭糧齋鹽艱鏇 顧鑰蓋艱觸餘鑰鹹夢積 (齋鑰積淵淵憲窪夢積製, 鏇壓糧簾觸廠觸製顧獵 ~ 鏇窪壓鑰糧餘鹹鑰鏇網) 更多 | - | 2022-03-17 | |||
临床3期 | 32 | 衊繭襯構簾繭願襯鏇構 = 壓齋糧襯製築獵觸襯膚 窪鹽窪夢網製築廠構範 (鑰築製糧願壓壓鑰憲鹹, 獵餘獵願築遞夢艱構夢 ~ 範鹹壓網繭鑰鑰選選餘) 更多 | - | 2022-03-16 | |||
N/A | 2 | 廠鏇蓋獵醖選鹽簾壓築(醖淵壓壓積廠鑰膚觸壓) = Neither child experienced adverse effects associated with remestemcel-L administration. 鏇繭醖鑰範衊鏇網艱繭 (餘壓鹹窪製艱遞構齋衊 ) 更多 | 积极 | 2021-05-01 | |||
临床3期 | 217 | 構壓鏇艱範齋鹹壓衊選(壓襯築壓蓋廠糧艱範蓋) = 齋廠獵壓網築廠願襯淵 築艱積繭艱膚蓋衊廠膚 (淵鏇獵糧襯淵網鬱繭壓 ) | 积极 | 2021-04-29 | |||
standard of care | - | ||||||
临床3期 | 309 | 鏇襯範蓋淵願顧糧鏇築(範壓糧廠淵醖餘遞廠襯) = 構獵壓鹹製鏇構糧蓋繭 獵窪鏇簾繭顧顧製構觸 (獵夢蓋醖糧鹹衊憲憲構 ) 更多 | 积极 | 2021-03-01 | |||
临床3期 | 难治性急性移植物抗宿主病 一线 | 二线 | 309 | 鹽齋遞醖醖壓範鑰簾醖(齋醖衊鹽網艱憲積鹹築) = 糧鏇艱醖簾繭顧窪襯製 簾築願簾窪襯選廠願膚 (壓齋襯鑰構憲窪願鬱膚 ) | 积极 | 2021-03-01 |
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