Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid Regression: Immunohistochemistry, Histopathology and Imaging Study

The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.

开始日期2020-09-01

申办/合作机构

PT Prodia Stemcell Indonesia

NCT04260698

/ Completed临床3期

An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

开始日期2020-07-08

申办/合作机构

Gamida Cell Ltd.

NCT03173937

/ Recruiting临床1/2期IIT

Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, to Expedite Engraftment and Improve Transplant Outcome

Background:
Severe aplastic anemia (SAA) and myelodysplastic syndrome (MDS) are bone marrow diseases. People with these diseases usually need a bone marrow transplant. Researchers are testing ways to make stem cell transplant safer and more effective.
Objective:
To test if treating people with SAA or MDS with a co-infusion of blood stem cells from a family member and cord blood stem cells from an unrelated donor is safe and effective.
Eligibility:
Recipients ages 4-60 with SAA or MDS
Donors ages 4-75
Design:
Recipients will be screened with:
* Blood, lung, and heart tests
* Bone marrow biopsy
* CT scan
Recipients will have an IV line placed into a vein in the neck. Starting 11 days before the transplant they will have several chemotherapy infusions and 1 30-minute radiation dose.
Recipients will get the donor cells through the IV line. They will stay in the hospital 3-4 weeks. After discharge, they will have visits:
* First 3-4 months: 1-2 times weekly
* Then every 6 months for 5 years
Donors will be screened with:
* Physical exam
* Medical history
* Blood tests
Donors veins will be checked for suitability for stem cell collection. They may need an IV line to be placed in a thigh vein.
Donors will get Filgrastim or biosimilar (G-CSF) injections daily for 5-7 days. On the last day, they will have apheresis: Blood drawn from one arm or leg runs through a machine and into the other arm or leg. This may be repeated 2 days or 2-4 weeks later.
...

开始日期2017-06-13

申办/合作机构

National Heart, Lung & Blood Institute

100 项与 Omidubicel (Gamida Cell) 相关的临床结果

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100 项与 Omidubicel (Gamida Cell) 相关的转化医学

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100 项与 Omidubicel (Gamida Cell) 相关的专利（医药）

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项与 Omidubicel (Gamida Cell) 相关的文献（医药）

2026-01-01·Stem Cell Reviews and Reports

Opening New Horizons: Advanced Hematopoietic Stem Cell Expansion Strategies Bridging Cord Blood Therapy from Bench To Bedside

Review

作者: Zhao, Yunyan ; Zhang, Yu ; Du, Wei ; Liu, Rongzhi ; Li, Guangzhao

Hematopoietic stem cell transplantation has been conducted in clinical settings to treat patients with malignant or non-malignant blood diseases for decades. Cord blood (CB) has been recognized as an essential graft source with beneficial characteristics, such as a lower risk of relapse and a lower rate of chronic graft-versus-host disease. However, the limited number of cells in CB impedes its broader use and hinders the ability to harness its benefits. Various expansion strategies have emerged to address this barrier, based on a deeper understanding of fate decisions and the maintenance of stemness in hematopoietic stem cells. To achieve an efficient transition from the laboratory to clinical application, several strategies have successfully managed scale-up manufacturing to satisfy clinically relevant requirements for both quality and scale. These approaches have progressed to the clinical stage and have demonstrated promising results. Novel expanded CB-derived hematopoietic stem and progenitor cells (HSPCs) therapies, including OMISIRGE (Omidubicel onlv.), Zemcelpro (Dorocubicel), and upcoming products with International Nonproprietary Name designations, introduce innovative concepts and comprehensive considerations for improving CB transplantation. This progress enables novel therapeutic options and represents a breakthrough in traditional CB transplants. In this context, we summarize and explore representative techniques and products to provide insights that inspire future developments in CB-derived HSPC therapies.

2025-08-01·Blood neoplasia

Outcomes of myeloablative allogeneic hematopoietic cell transplantation with omidubicel vs alternative donor sources

Article

作者: He, Chujun ; Burns, Linda J ; Xu, Chunyi ; Tang, Xiao-Ying ; Sajeev, Gautam ; Zhang, Mei-Jie ; Horwitz, Mitchell E ; Simantov, Ronit ; Sivaraman, Smitha ; Signorovitch, James E ; Song, Yan ; Shin, Heayoung ; Lin, Chenyu

Omidubicel is a nicotinamide-expanded stem cell product derived from umbilical cord blood (UCB). In a phase 3 randomized trial for high-risk hematologic malignancies, omidubicel had faster neutrophil engraftment and fewer infectious complications than standard UCB transplantation. However, the clinical outcomes of omidubicel relative to other stem cell donor sources are yet to be determined. Clinical data for patients who underwent allogeneic hematopoietic cell transplantation (HCT) with omidubicel and standard UCB were taken from the phase 3 trial. The Center for International Blood and Marrow Transplant Research (CIBMTR) registry provided contemporaneous comparator cohorts of patients who met the trial eligibility criteria and who received allogeneic HCT from matched unrelated (MUD), mismatched unrelated (7/8 MMUD), and haploidentical donors. A total of 951 patients met the eligibility criteria, including 52 for omidubicel, 56 for standard UCB, 65 for 7/8 MMUD, 450 for MUD, and 328 for haploidentical donors. Omidubicel was associated with more rapid neutrophil engraftment than all other donor sources but slower platelet engraftment relative to other donor sources aside from UCB. There were no significant differences in overall survival, disease-free survival, and nonrelapse mortality among the donor sources. Omidubicel had a higher incidence of grade 2 to 4 acute graft-versus-host disease (GVHD), but similar rates of grade 3 to 4 acute GVHD and chronic GVHD compared to the CIBMTR cohorts. These results support the role of omidubicel as a viable donor source in the current transplant landscape.

2025-07-01·Transplantation and Cellular Therapy

Omidubicel-onlv Transplantation for Hematologic Malignancies: Results of a Multicenter Expanded Access Program

Article

作者: Schiller, Gary J ; Rezvani, Andrew R ; Tsai, Stephanie B ; Levy, Stuart ; Mazor, Roei D ; Maziarz, Richard T ; Goshen, Uri ; Schwarzbach, Aurélie ; Stiff, Patrick J ; Horwitz, Mitchell E

Omidubicel-onlv is an FDA-approved, nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood (UCB). A phase 3 study demonstrated improved hematopoietic recovery and decreased infections with omidubicel compared with UCB allogeneic transplantation. We report results of an Expanded Access Program evaluating clinical outcomes in patients with hematologic malignancies following transplantation with omidubicel. Between August 2020 and May 2023, 29 patients were transplanted at 5 US sites. Patients received myeloablative conditioning, prophylactic and therapeutic medications, and supportive care per institutional guidelines, and were monitored for engraftment, infections, and graft-versus-host-disease (GVHD) for up to 2 years post-transplant. Results were compared with previously reported phase 3 outcomes. Omidubicel recipients had a median age of 39 (range 20-73, 62% male); 45% were non-White and 65.5% had acute leukemia. Median follow-up was 11.8 (range: .3-27.7) months. Median neutrophil and platelet engraftment times were 12 and 33.5 days, respectively. Acute GVHD (grade 3-4) at day 100 occurred in 19% of patients, with chronic GVHD at 1 year in 9% of patients, all of which were mild. First grade 2 to 3 bacterial infections through 100 days post-transplant and first grade 3 viral infection 1 year post-transplant occurred in 18% and 12% of patients, respectively. One-year disease-free survival and overall survival rates were 76% and 87%, respectively. This real-world study of omidubicel transplantation for hematologic malignancies finds that this graft source is commonly used for non-White allogeneic transplant recipients. The rapid engraftment kinetics observed following transplantation with omidubicel appears to have addressed excessive nonrelapse mortality that has been previously observed following myeloablative umbilical cord blood transplantation.

140

项与 Omidubicel (Gamida Cell) 相关的新闻（医药）

2026-03-17

·冬藏生物

当疾病来袭，干细胞的修复力和免疫细胞的战斗力，哪个能救你？

上一期我们读懂了细胞治疗的核心逻辑，今天我们接着科普。面对细胞治疗，很多朋友其实并不在乎这种方式到底有多神奇，因为细胞治疗背后的科学那是科学家的事，作为普通人，我们最关心的是： “当疾病来袭，干细胞的修复力和免疫细胞的战斗力，到底哪个能救我？”“两者到底有啥区别？”“哪种细胞治疗适合家里老人的病？”…… 今天，本号联合安徽省循证医学学会细胞工程与转化分会、中科冬藏医疗专家委员会，继续拆解细胞治疗家族，详细介绍5大核心类型，对比各自优劣，解答你最关心的疑问，看完再也不混淆！ 01 细胞治疗家族到底有哪些“成员”？很多人提到细胞治疗，最先关注的就是干细胞和免疫细胞——毕竟大家都在问“两者哪个能救自己”，其实细胞治疗是一个“大家族”，包含5大核心类型，每一种都有自己的“专属本领”，适配不同的疾病需求。具体可分为以下几类： 1. 干细胞疗法（家族“修复能手”）； 2. 免疫细胞疗法（家族“防御卫士”）； 3. 其他体细胞疗法（家族“专项助手”）； 4. 细胞衍生物疗法（家族“延伸战力”）； 5. 基因修饰细胞疗法（家族“升级版本”）。接下来，我们逐一拆解每类疗法的“核心技能”，重点说清干细胞的修复力、免疫细胞的战斗力，结合原理、特点和应用场景，帮你分清它们的区别，彻底搞懂“哪种能救你”，再也不被专业术语绕晕。 02 5大细胞治疗类型各自有啥本事？ 1. 干细胞疗法：身体的“万能修复师”，靠修复力守护健康核心原理：干细胞就像身体里的“万能细胞”，拥有强大的分化潜能，能分化成人体多种组织细胞（比如神经细胞、软骨细胞、心肌细胞），核心作用是修复受损组织、再生坏死细胞，从根源上解决组织损伤类疾病。核心特点：来源广泛（可来自自身骨髓、脐带血、脂肪等），适配性强，副作用小，主打“温和修复”，不直接攻击病变细胞，而是通过再生能力恢复身体机能。应用领域：主要用于治疗组织损伤、慢性病及难治性疾病，比如白血病（造血干细胞移植）、骨关节炎（修复关节软骨）、心肌梗死（修复受损心肌）、帕金森病（再生神经细胞）、糖尿病（修复胰岛功能）等。代表技术：造血干细胞移植、间充质干细胞治疗、神经干细胞移植等，其中间充质干细胞因来源广泛、安全性高，是目前临床应用最广泛的干细胞技术之一。应用领域与 2025-2026 全球最新进展：血液疾病：造血干细胞移植为白血病核心疗法；美国 FDA 2025 年 12 月批准脐带血扩增疗法 Omisirge® 新增重型再生障碍性贫血适应症，该疗法使 94% 患者实现快速造血恢复，中性粒细胞植入中位时间仅 8 天。骨科疾病：韩国 5 年随访证实，自体脂肪间充质干细胞关节腔注射可将骨关节炎患者关节置换率从 82% 降至 17%。心血管疾病：日本 Cuorips 公司提交 iPSC 来源心肌细胞贴片商业化申请，该 0.1 毫米超薄贴片可微创修复严重心力衰竭，有望成为全球首款 iPSC 细胞治疗产品。糖尿病：解放军总医院 2025 年 8 月数据显示，脐带间充质干细胞三次输注可使 59% II 型糖尿病患者达到 HbA1c<7% 且血糖达标时间≥70% 的理想标准，部分患者胰岛素用量减少 35%；国内某企业的VX-880 干细胞来源胰岛细胞移植让 83%1 型糖尿病患者实现胰岛素独立。神经疾病：帕金森干预成果 UX-DA001 获中美加速通道，2027 年拟在海南博鳌落地；韩国 Neuronata-R 疗法对慢进展渐冻症患者有效，计划 2026 年提交 FDA 上市申请。免疫疾病：中国首款干细胞药物 "艾米迈托赛注射液"2025 年 1 月获批，用于激素难治性急性移植物抗宿主病，使患者 24 个月生存率提升至 74.2%；脐带来源间充质干细胞可使单倍体造血干细胞移植患者严重 GVHD 发生率降低 40%-65%。 2. 免疫细胞疗法：身体的“抗癌卫士”，靠战斗力清除病灶核心原理：利用人体自身的免疫细胞（比如T细胞、NK细胞），通过体外激活、改造（比如基因编辑），让它们拥有更强的识别和攻击能力，再回输到患者体内，精准击杀病变细胞（尤其是癌细胞），同时增强身体自身的免疫力。核心特点：针对性强，能精准识别病变细胞，不损伤正常细胞，主打“主动攻击”，尤其适合癌症治疗，部分疗法可实现“临床治愈”。应用领域：主要用于癌症治疗，也可用于增强免疫力、预防癌症复发，比如B细胞淋巴瘤、白血病、肺癌、胃癌、肝癌等，其中CAR-T疗法在血液肿瘤治疗中成效显著。代表技术：CAR-T细胞疗法（嵌合抗原受体T细胞疗法）、NK细胞疗法、肿瘤浸润淋巴细胞（TIL）疗法等，其中CAR-T疗法是目前最受关注的免疫细胞治疗技术，已在全球多个国家获批临床应用。 3. 其他体细胞疗法：“专项修复员”，针对性解决单一问题核心原理：选取人体特定的体细胞（非干细胞、非免疫细胞，比如皮肤细胞、肝细胞、软骨细胞），通过体外培养、增殖，再回输到患者体内，修复特定部位的受损组织。核心特点：针对性极强，只针对某一种体细胞进行修复，不具备分化能力，操作相对简单，安全性高。应用领域：主要用于单一组织损伤的修复，比如皮肤烧伤（皮肤细胞移植）、肝硬化（肝细胞移植）、软骨损伤（软骨细胞移植）等，是临床中最成熟、应用最广泛的细胞治疗类型之一。 4. 细胞衍生物疗法：“延伸战力”，无需回输细胞核心原理：不直接回输细胞，而是提取细胞分泌的活性物质（比如细胞因子、外泌体、生长因子等），这些物质能调节人体免疫功能、促进细胞修复，间接达到治疗效果。核心特点：无需体外培养、回输细胞，操作更简便，风险更低，适合无法接受细胞回输的人群，可作为辅助治疗手段。应用领域：主要用于辅助治疗癌症、慢性病，以及改善亚健康、延缓衰老，比如用细胞因子增强癌症患者免疫力，用外泌体修复皮肤损伤、改善皮肤状态等。 5. 基因修饰细胞疗法：“升级加强版”，攻克遗传性疾病核心原理：先对细胞进行基因编辑（比如修复基因突变、插入功能性基因），再将编辑后的细胞回输到患者体内，从基因层面解决疾病根源，尤其适合遗传性疾病。核心特点：技术难度高，针对性解决基因缺陷问题，能实现“根治”某些遗传性疾病，是目前细胞治疗领域的前沿方向。应用领域：主要用于遗传性疾病、罕见病治疗，比如脊髓性肌萎缩症、血友病、地中海贫血等，部分罕见病通过该疗法已实现临床缓解。 03 干细胞vs免疫细胞到底谁更厉害？对于我们普通老百姓来说，日常接触到的细胞治疗无外乎两种：干细胞治疗和免疫细胞治疗。那么问题是：干细胞和免疫细胞，到底该选哪个？其实没有“谁更厉害”，只有“谁更适合”，一张通俗对比表，帮你快速分清： ✅ 干细胞疗法：主打“修复”，适合组织损伤、慢性病（如关节炎、糖尿病、帕金森），温和安全，侧重“补短板”，修复受损身体机能； ✅ 免疫细胞疗法：主打“攻击”，适合癌症、免疫力低下，精准击杀病变细胞，侧重“除隐患”，清除体内异常细胞；补充：两者也可联合使用，比如癌症患者术后，用免疫细胞疗法清除残留癌细胞，用干细胞疗法修复手术损伤，提升治疗效果。 04 老百姓最关心的4个问题一次性解答 1. 干细胞和免疫细胞，来源哪里？ —— 干细胞可来自自身骨髓、脂肪、脐带血（合法合规采集）；免疫细胞主要来自自身外周血，采集方便，无需手术。 2. 这些细胞治疗，安全吗？ —— 正规机构的细胞治疗，都会经过严格的细胞培养、质量检测和临床试验，安全性有保障，但需在专业医生指导下进行，避免非法机构骗局。 3. 治疗效果能保证吗？ —— 效果因人而异，取决于疾病类型、病情严重程度和个人体质，比如早期癌症用免疫细胞疗法效果更好，轻度关节炎用干细胞疗法缓解更明显，无法保证“100%有效”。 4. 其他类型的细胞治疗，普通人能用到吗？ —— 体细胞疗法、细胞衍生物疗法已相对成熟，比如皮肤烧伤的体细胞移植、亚健康人群的细胞因子调理，普通人可在正规机构咨询使用。看完这篇，相信你已经摸清了细胞治疗家族的“底细”：5大类型各有专长，干细胞管“修复”，免疫细胞管“抗癌”，没有优劣之分，只有适配之别。很多人会问：这么厉害的细胞治疗，离我们普通人到底有多远？它从实验室走到临床，经历了哪些坎坷？下期内容，我们就来聊聊细胞治疗的“前世今生”，揭秘它从实验室走向临床的漫漫征程，记得持续关注，解锁更多细胞治疗干货～最后，如果你对某类细胞治疗有疑问，或者想了解自己的病情是否适合细胞治疗，欢迎在评论区留言，我们联合权威专家为你解答！ 👒 “如果您还对细胞治疗有疑问，请留言” 冬藏细胞应用，让我们重来一次相遇。留言区等你分享！ 📮工作微信：DCSW520520 不用等新药！301 医院 91 例数据实锤：二甲双胍 + 常规干细胞，胰岛素大减 35%，还能护胰岛中国首例干细胞造 “人工胰岛” 获批！1.4 亿糖友能少打 / 停打胰岛素？｜上海长征医院：微创一次稳定血糖雄安国家干细胞中心揭牌！细胞治疗从“百万天价”到“普通人可及”，救命药终于落地了！多国联合突破：TCR-T疗法SCG101实现乙肝功能性治愈，病毒清除率92%！TCR-T疗法如何做到“一次治愈”？现在起，乙肝可彻底治愈？全球首款乙肝靶向细胞疗法在中国获批：SCG101V开启病毒清除新时代干细胞回输为啥必须 “连输三次”？最新临床数据曝光：少 1 次，存活率差 5.8 倍！不仅要连输，这些细节决定效果监制 | 海燕编辑 | KIM 校对 | 老金 ©冬藏生物点个赞吧！🍃

细胞疗法免疫疗法

2026-02-09

·BioSpace

Ayrmid Appoints ACA Pharma as Exclusive Distributor for Omisirge(R) across Greater China and Southeast Asia

ACA Pharma granted exclusive rights to register and distribute Omisirge across 15 markets, covering both FDA-approved Omisirge indications DUBLIN, IE / ACCESS Newswire / February 9, 2026 / Ayrmid, Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., today announced that it has appointed ACA Pharma as its exclusive distributor for Omisirge (Omidubicel-onlv) and granted ACA Pharma exclusive rights to seek registration and to distribute Omisirge across the following jurisdictions: Mainland China, Hong Kong SAR, Macau SAR, Mongolia, Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam and Timor-Leste. Under the terms of the agreement, ACA Pharma will hold exclusive rights to register and distribute Omisirge across the Territory; the parties will prioritize specific jurisdictions for regulatory and launch planning based on local requirements and commercial considerations. Initial efforts may focus on lighthouse centers in Macau and Singapore, with additional jurisdictions assessed over time. Dr. Joe Wiley, CEO and Chairman of Ayrmidcommented: "This agreement represents continued progress as we expand access for patients in existing and new territories. Omisirge represents an important advancement in cell therapy and we look forward to working with the team at ACA as we continue to advance our innovative therapies to help patients with serious unmet medical needs." Mike Zhou, CEO of ACA Pharmacommented: "This appointment reflects a shared commitment to responsibly expanding access to Omisirge for appropriate patients across Greater China and Southeast Asia. ACA Pharma's platform is built for complex specialty products-combining regulatory execution, hospital launch capability, and end-to-end distribution-while maintaining the highest standards for quality and patient safety." About Omisirge Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. Omisirge is approved in the United States for: (1) adults and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; and (2) adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced-intensity conditioning. About Ayrmid Ltd. and Gamida Cell Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge ® (please see the current full Prescribing Information, including boxed warning, here ) and APHEXDA ® (please see the current full Prescribing Information here ). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit or follow Gamida Cell on LinkedIn , X , Facebook or Instagram . Contacts: Media, Investors / Business Development: bd@ayrmid.com About ACA Pharma Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices worldwide. The company is best known for its Macau Fast-Track platform for medicines and Hong Kong Fast-Track pathway for advanced devices, which can enable market entry in as little as 30-90 days in Macau and approximately three months in Hong Kong. These hubs then serve as launchpads to bridge into mainland China via the Greater Bay Area and other national pilot zones, with the real-world evidence generated supporting accelerated national approvals - particularly for products addressing unmet medical need, clinically urgent conditions, or rare diseases. Learn more at This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Ayrmid Pharma Ltd View the original press release on ACCESS Newswire

细胞疗法引进/卖出上市批准临床研究加速审批

2026-02-05

·BioSpace

Ayrmid and Ariti Sign Distribution Agreement for Omisirge(R) in Greece and Cyprus

DUBLIN, IE / ACCESS Newswire / February 5, 2026 / Ayrmid, Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., today announced that it has entered into an exclusive distribution agreement with Ariti S.A., a Greece based pharmaceutical company for the distribution of Omisirge (Omidubicel-onlv) in Greece and Cyprus. Under the terms of the agreement, Ariti will provide services to support early access schemes to Omisirge in the agreed territories, leveraging its established expertise in hematology and local market infrastructure. Dr. Joe Wiley, Chief Executive Officer and Chairman of Ayrmidccommented: "This agreement represents continued progress as we expand access for patients in existing and new territories. We look forward to working with the team at Ariti and we remain deeply committed to advancing innovative therapies to help patients with serious unmet medical needs." Mr. Serafeim Kyrkos, Chief Executive Officer of Ariti S.A.commented: "This collaboration brings together our broad expertise in hematology with Ayrmid's innovative therapies, including Omisirge, the only FDA approved cell therapy for allogenic transplant for hematologic malignancies and for the treatment of Severe Aplastic Anemia. For both companies, this represents a tremendous opportunity to support market access in Greece and Cyprus, while driving mutual growth in the haemato-oncology segment". About Omisirge Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. Omisirge is approved in the United States for: (1) adults and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; and (2) adults and pediatric patients 6 years of age and older with severe aplastic anemia following reduced-intensity conditioning. About Ayrmid Ltd. and Gamida Cell Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge ® (please see the current full Prescribing Information, including boxed warning, here ) and APHEXDA ® (please see the current full Prescribing Information here ). Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit or follow Gamida Cell on LinkedIn , X , Facebook or Instagram . Contacts: Media, Investors / Business Development: bd@ayrmid.com About Ariti S.A. Ariti S.A., founded in 1985, is a well-established Greek healthcare company active in the pharmaceutical and medical sector. Over the past decades, the Company has built a strong track record in the exclusive representation, distribution and commercialization of pharmaceutical and healthcare products in Greece, in collaboration with reputable international partners. With extensive local expertise, Ariti leverages a solid commercial and regulatory infrastructure to support market access and broad product availability across Greece and Cyprus. Ariti also maintains an owned nationwide network of 10 chronic hemodialysis care units in Greece, strengthening its healthcare footprint and supporting its long-term commitment to improving patient outcomes. For additional information, please visit Ariti SA or follow Ariti SA on LinkedIn This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Ayrmid Pharma Ltd View the original press release on ACCESS Newswire

引进/卖出细胞疗法上市批准免疫疗法生物类似药

100 项与 Omidubicel (Gamida Cell) 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
再生障碍性贫血	美国	Gamida Cell Ltd.	2025-12-08
血液肿瘤	美国	Gamida Cell Ltd.	2023-04-17

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
急性白血病	临床3期	美国	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	巴西	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	法国	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	以色列	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	意大利	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	荷兰	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	葡萄牙	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	新加坡	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	西班牙	Gamida Cell Ltd.	2016-12-16
急性白血病	临床3期	英国	Gamida Cell Ltd.	2016-12-16

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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


Tandem Meetings ASTCT and CIBMTR2026	N/A	移植物抗宿主病	18	Omidubicel	願鏇餘鹽鹹餘製淵鑰鹽(構遞顧獵淵憲鏇憲積艱) = 壓顧製鹽鏇鏇繭簾鏇壓積選簾鹽齋膚遞鑰選襯 (鬱艱顧鬱憲簾網積遞構 ) 更多	积极	2026-02-04
				Omidubicel	憲顧廠積鑰鏇觸觸築範(餘鬱壓觸衊築遞鹽繭觸) = 鏇繭夢襯築範夢獵壓憲網觸夢鹹窪顧構淵蓋齋 (襯鏇襯鏇顧蓋築齋選獵 ) 更多
BusinessWire 人工标引	临床1期	再生障碍性贫血	14	Omidubicel	襯憲膚蓋願積鬱遞鏇廠(範鬱窪衊鏇願鹹觸膚繭) = 觸夢餘鹽壓餘築鑰淵獵選繭繭築觸憲鏇窪積簾 (願窪觸憲憲餘艱網築鹽 ) 更多	积极	2025-10-28
NCT02730299 (Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床3期	血液肿瘤	-	Omidubicel (EAP)	廠顧觸鹽餘願糧餘憲淵(遞遞鹹淵獵鹽築窪餘積) = 鬱製積鹹繭蓋淵鹹顧糧膚遞衊鹹選選壓範膚鏇 (廠顧簾廠網蓋遞廠簾範 ) 更多	积极	2024-02-22
				omidubicel (P3-OMI)	廠顧觸鹽餘願糧餘憲淵(遞遞鹹淵獵鹽築窪餘積) = 壓餘網選廠鬱鏇構獵廠膚遞衊鹹選選壓範膚鏇 (廠顧簾廠網蓋遞廠簾範 ) 更多
NCT02730299 (Pubmed \| Transplant Cell Ther)	临床3期	血液肿瘤	108	Omidubicel-onlv	繭繭鏇鑰選繭選膚壓衊(膚願願獵糧構網選簾選) = 衊繭顧積築積構構齋繭簾淵繭鬱艱齋構膚鏇築 (鑰遞鹹餘餘醖糧網艱製 ) 更多	积极	2023-12-01
				Umbilical Cord Blood Transplantation	繭繭鏇鑰選繭選膚壓衊(膚願願獵糧構網選簾選) = 廠夢遞醖壓選艱鏇醖淵簾淵繭鬱艱齋構膚鏇築 (鑰遞鹹餘餘醖糧網艱製 ) 更多
NCT02730299 (Phase 3 Substudy, Pubmed \| Transplant Cell Ther)	临床3期	器官移植排斥	37	Omidubicel	鬱築築願壓選願糧製顧(鬱遞夢齋憲選網醖願齋) = 構齋醖襯壓蓋醖選蓋窪齋衊壓鬱膚觸糧艱衊觸 (製築淵範淵窪網壓繭網 ) 更多	积极	2023-08-01
				Omidubicel (Standard UCB)	壓簾鹹夢顧製鬱遞鹹遞(構齋獵積鑰鹹願鹹夢網) = 簾鹹糧膚選遞鑰鏇鏇獵選廠觸築構艱襯鹽蓋積 (構廠醖夢餘壓衊鬱衊餘 )
NCT02730299 (FDA) 人工标引	临床3期	血液肿瘤	125	OMISIRGE	廠廠鹽鬱廠艱淵繭鬱積(鬱鏇醖製構選膚遞積窪) = 繭窪網窪糧顧餘醖廠艱蓋網夢構鹽廠鬱廠淵構 (簾憲壓積觸餘顧衊構糧, 10 ~ 15) 更多	优效	2023-04-17
				Umbilical Cord Blood	廠廠鹽鬱廠艱淵繭鬱積(鬱鏇醖製構選膚遞積窪) = 衊鏇淵簾醖蓋齋製壓鹽蓋網夢構鹽廠鬱廠淵構 (簾憲壓積觸餘顧衊構糧, 19 ~ 25) 更多
phase III trial (SOHO2022)	临床3期	造血干细胞移植	108	Omidubicel	襯遞選製選淵選鑰夢壓(憲鏇鑰網膚鹹窪壓鏇鏇) = 顧齋蓋獵願餘襯顧積鏇襯餘積網觸糧顧簾遞餘 (願鏇選衊膚製蓋齋願鹽, p = 0.04) 更多	积极	2022-10-01
SOHO2022	临床3期	造血干细胞移植	116	Omidubicel	夢積餘壓窪鑰選積積網(齋鬱糧範夢選糧範齋獵) = 觸襯餘鬱糧築願窪鏇製網齋齋顧壓齋糧積壓製 (範廠觸繭淵繭構觸築鏇, 47.0–67.1) 更多	积极	2022-10-01
NCT02730299 (phase III, Tandem Meetings ASTCT and CIBMTR2022)	临床3期	血液肿瘤	-	Omidubicel	積膚獵獵製願製製衊窪(衊淵鏇蓋廠窪獵淵艱鬱) = 範積繭獵網築蓋選糧繭觸窪糧憲獵餘範鏇蓋廠 (膚網獵鑰鏇願鏇築繭構 ) 更多	积极	2022-03-01
				Omidubicel (Umbilical Cord Blood (UCB))	積膚獵獵製願製製衊窪(衊淵鏇蓋廠窪獵淵艱鬱) = 願鏇鑰觸廠範繭窪襯繭觸窪糧憲獵餘範鏇蓋廠 (膚網獵鑰鏇願鏇築繭構 ) 更多
NCT02730299 (global phase III trial of omidubicel vs standard UCB, Tandem Meetings ASTCT and CIBMTR2022)	临床3期	造血干细胞移植 CD133+ \| CD3+ \| CD4+	125	Omidubicel	憲顧蓋醖觸艱衊鏇衊觸(壓範憲醖繭網鏇願築糧) = Robust recovery of CD4+ T cell, NK and B cell, myeloid and plasmacytoid dendritic cells was observed within the first 3 weeks after omidubicel. Significantly lower rates of severe bacterial infections in the same period likely reflect the effect of shortened duration neutropenia. We hypothesize that the lower rates of bacteremia and sepsis permitted superior survival of these immune cells despite the lower infused cell dose, potentially contributing to the lower viral infection rate observed in the omidubicel cohort. 製鏇膚鹹夢蓋壓鑰蓋繭 (鹹範鏇構製觸鹽壓鏇膚 )	积极	2022-03-01
				Omidubicel (Standard Umbilical Cord Blood)