This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma. Surgical margins are one of the criteria used in assessing the effectiveness of a given surgical procedure. They are the edges or border of the tissue removed in cancer surgery. A negative margin means that the resected tumor is surrounded by normal tissue, which implies there is no disease left in the patient. By contrast, a positive margin means that sarcoma cells are visible at the edge of the tumor. Positive margins may be classified as planned when they are expected pre-operatively due to the preservation of a critical structure, or unexpected when the pathologist reports the presence of tumor at the margin despite the surgeon having intended to remove it in its entirety. Fluorescence-guided surgery is an established surgical method that involves the administration of fluorescent dye (in this case, indocyanine green) into the tumor, which can then be visualized with a special camera during surgery to help surgeons identify tumor versus healthy tissue. Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma.

开始日期2027-05-15

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07481760

/ Not yet recruitingN/AIIT

Multicenter Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence to Reduce Biliary Complications in Emergency Cholecystectomy for Acute Cholecystitis

Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials.
The objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG.
This is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.

开始日期2027-01-01

申办/合作机构

Hospital del Mar

NCT05038098

/ Not yet recruiting临床1期IIT

Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial

This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.

开始日期2026-12-31

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与吲哚菁绿相关的临床结果

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100 项与吲哚菁绿相关的转化医学

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100 项与吲哚菁绿相关的专利（医药）

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6,299

项与吲哚菁绿相关的文献（医药）

2027-02-01·BIOMATERIALS

Coassembled peptide nanoparticles enable stage-specific diagnosis and targeted therapy of hepatic fibrosis by inhibiting macrophage-driven inflammation

Article

作者: Li, Bowen ; Ma, Yuerong ; Bao, Jianwei ; Zou, Qianli ; Pan, Chenchen

Hepatic fibrosis represents a major unmet clinical challenge, given its insidious progression and the lack of effective diagnostic and therapeutic strategies. To address this gap, we constructed supramolecular assemblies integrating an antifibrotic peptide with indocyanine green (ICG), a clinically approved dye for hepatic function assessment. The resulting ICG-peptide nanoparticles (ICG-peptide-NPs) integrate the therapeutic activity of the antifibrotic peptide with the diagnostic capacity of ICG. They significantly extend the diagnostic window of ICG from 15 to 60 min and improve diagnostic performance for liver fibrosis staging. Benefiting from prolonged blood circulation and selective accumulation in fibrotic liver tissue, ICG-peptide-NPs exhibit markedly enhanced antifibrotic efficacy. Mechanistically, they inhibit macrophage M1 polarization through the FPR2/STAT3 pathway. This effect reduces inflammatory factor secretion, suppresses extracellular matrix deposition, and normalizes serum liver function markers. We further demonstrate that ICG-peptide-NPs dampen aberrant immune responses during liver fibrosis progression by blocking the recruitment of monocyte-derived macrophages. The FPR2/STAT3-mediated signaling pathway is further validated at the transcriptomic level via whole-genome RNA sequencing. With favorable biocompatibility and enhanced antifibrotic efficacy, these multifunctional peptide assemblies offer a novel strategy for the integrated diagnosis and treatment of hepatic fibrosis.

2026-12-01·JOURNAL OF BIOLOGICAL PHYSICS

Coupled optical-thermal-chemical modeling of pulsed 808-nm ICG phototherapy using Monte Carlo photon transport

Article

作者: J M Tamimi, Zeina ; Gide, Bashir ; Al Timimi, Zahra

Phototherapy using indocyanine green (ICG) has been shown to utilize photothermal and photodynamic effects, and its effectiveness is determined through complex interactions of light transport, heat generation, and reactive oxygen species (ROS) production. In this paper, we report a computational framework for simulating the pulsed 808-nm photoactivation of ICG in a three-dimensional tumor spheroid. Photon transport in the heterogeneous spheroid domain is simulated using GPU-accelerated Monte Carlo photon transport, and the absorbed optical energy is coupled with a transient bioheat equation, an oxygen diffusion-reaction equation, and ROS production equation. The computational domain was defined as a voxelized spheroid with dimensions of 100 × 100 × 100 voxels, which represented the hypoxic tumor core and proliferative tumor areas. The simulation revealed that the fluence distribution is heterogeneous with significant attenuation, with about 70% being reduced within the first 400 µm. The maximum temperature ranged from 41.2 ± 0.6 to 53.6 ± 1.4 °C based on the pulse duration. The oxygen-dependent ROS generation was found to be highest in the oxygenated proliferative shell, whereas the hypoxic tumor core presented reduced photodynamic effects. The coupled cytotoxicity simulation revealed apoptotic-dominant areas in the oxygen-enriched tumor and necrosis due to heat in the case of increased pulse energy. The pulse duration, oxygen diffusion coefficient, and ICG absorption strength were found to be the most significant parameters affecting the treatment outcome based on the sensitivity analysis. The proposed multiphysics approach can be used as a quantitative tool to analyze laser-induced tumor phototherapy and can be helpful in the computational optimization of the treatment approach. The model is physics-based, and it predicts relative response tendencies to therapy rather than actual biological responses.

2026-12-01·COLLOIDS AND SURFACES B-BIOINTERFACES

NIR-activated antimicrobial peptide-functionalized nanoparticles for eradication of biofilms and healing of infected diabetic wounds

Article

作者: Shi, Linxuan ; Ma, Yiping ; Liu, Lu ; Bai, Yueping ; Wang, Shuo ; Li, Cui

The formation of bacterial biofilms at infection sites represents a major obstacle to the effective healing of diabetic wounds. Biofilm-associated diabetic wounds are exceedingly difficult to manage, compounded by the increasing prevalence of antibiotic-resistant strains and the limited pipeline of novel antibacterial agents. To address this challenge, we designed polydopamine-HHC36-indocyanine green nanoparticles (PHI NPs) as an alternative therapeutic platform to conventional antibiotics. PHI NPs were fabricated by encapsulating the phototherapeutic agent indocyanine green (ICG) within a polydopamine (PDA) matrix, followed by surface functionalization with the cationic antimicrobial peptide HHC36 for autonomous and selective pathogen targeting. In vitro, PHI NPs bound Staphylococcus aureus with high affinity. Following intravenous administration in vivo, PHI NPs effectively accumulated at infected sites in a murine diabetic wound model. Upon near-infrared (NIR) laser irradiation, PHI NPs disrupted the biofilm architecture and subsequently eradicated the exposed bacteria through synergy between phototherapy (combining photothermal and photodynamic effects) and the antimicrobial peptide. Notably, bactericidal efficacy was robust under mild photothermal conditions (<45 °C), ensuring a favorable safety profile. In conclusion, PHI NPs constitute a potent and biocompatible platform for eradicating biofilm-associated infections and promoting wound healing of diabetic wounds whilst avoiding induction of antibiotic resistance.

123

项与吲哚菁绿相关的新闻（医药）

2026-09-23

·PRNewswire

Sagent Pharmaceuticals Launches Zyogreen®, the First and Only Ready-to-Use Indocyanine Green Injection in the U.S.

New ready-to-use fluorescent imaging agent eliminates reconstitution at the point of care, giving surgical and imaging teams a differentiated option for fluorescence-guided procedures Sept. 22, 2026 -- Sagent Pharmaceuticals ("Sagent"), a leading provider of generic and specialty pharmaceuticals, today announced that Zyogreen® (indocyanine green injection), the first and only FDA-approved ready-to-use (RTU) indocyanine green (ICG) injection in the United States, is now commercially available. The U.S. market for indocyanine green was approximately $128 million for the twelve months ended July 2026 (IQVIA). Zyogreen is marketed and distributed in the U.S. by Sagent under an agreement with Provepharm, a global leader in medical and diagnostic dyes. Zyogreen is an optical imaging agent used in fluorescence-guided procedures and diagnostic imaging. Surgeons performing vascular, gastrointestinal, organ transplant, plastic, and reconstructive procedures – including minimally invasive surgery – as well as those visualizing extrahepatic biliary ducts, gynecologic oncologists performing lymphatic mapping in cervical and uterine cancer, and ophthalmologists performing angiography now have access to a ready-to-use ICG formulation. Unlike conventional ICG products, which are supplied as a lyophilized powder that must be reconstituted before administration, Zyogreen is supplied as a sterile solution with no reconstitution required. For visualization of extrahepatic biliary ducts, Zyogreen is indicated in adults and in pediatric patients from birth to less than 1 year of age and 6 years of age and older. "This launch represents another important milestone in Sagent's evolution as a specialty pharmaceutical company," said Vishy Chebrol, Chief Executive Officer of Sagent Pharmaceuticals. "Zyogreen brings the established clinical utility of indocyanine green together with the convenience of a ready-to-use formulation, and it adds another FDA-approved source of a product that surgical and imaging teams depend on. Through our partnership with Provepharm, we are working to strengthen the reliability of supply for the hospitals and health systems we serve and to support the growing use of fluorescence-guided imaging." "Zyogreen is a true innovation emerging from Provepharm's research and development expertise, introducing a ready-to-use formulation to fluorescence imaging," said Michel Feraud, chairman and founder of Provepharm. "Partnering with Sagent brings that innovation to hospitals and surgical teams across the United States, and reflects our long-term commitment to supporting healthcare professionals and the patients in their care." Zyogreen is the second Provepharm dye Sagent has brought to the U.S. market, joining Bludigo® (indigotindisulfonate sodium injection), the first and only FDA-approved injectable indigo carmine diagnostic dye. Together, the two products establish Sagent's growing presence in surgical and diagnostic visualization and provide a strong foundation for continued growth in this evolving field. Zyogreen is available now through Sagent's nationwide distribution network. Zyogreen® (indocyanine green injection) is a sterile, ready-to-use optical imaging agent for intravenous or interstitial use. Zyogreen is indicated for fluorescence imaging of vessels, blood flow and tissue perfusion in adults and pediatric patients; fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older; fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer; and ophthalmic angiography in adults and pediatric patients. Please see full Prescribing Information for complete indication and safety information. Sagent Pharmaceuticals is a leading provider of generic and specialty pharmaceuticals serving hospitals, health systems, and healthcare providers throughout the United States. Through strategic partnerships, advanced drug delivery technologies, and a growing portfolio of differentiated products, Sagent is committed to delivering high-quality medicines that support patient care and improve healthcare delivery. Sagent is headquartered in Schaumburg, Illinois. Provepharm is a pharmaceutical company specializing in the development of high-quality, effective and ready-to-use dyes designed to improve visualization and detection in clinical practice. With almost 30 years of expertise, our innovation is grounded in organic chemistry and advanced formulation technologies, ensuring the quality, performance and ease of use of our dyes in the operating room. www.provepharm.com Zyogreen® and Bludigo® are registered trademarks of Provepharm SAS. The content above comes from the network. if any infringement, please contact us to modify.

上市批准

2026-09-23

·BioSpace

Sagent Pharmaceuticals Launches Zyogreen®, the First and Only Ready-to-Use Indocyanine Green Injection in the U.S.

New ready-to-use fluorescent imaging agent eliminates reconstitution at the point of care, giving surgical and imaging teams a differentiated option for fluorescence-guided procedures SCHAUMBURG, Ill. , Sept. 22, 2026 /PRNewswire/ -- Sagent Pharmaceuticals ("Sagent"), a leading provider of generic and specialty pharmaceuticals, today announced that Zyogreen® (indocyanine green injection) , the first and only FDA-approved ready-to-use (RTU) indocyanine green (ICG) injection in the United States, is now commercially available. The U.S. market for indocyanine green was approximately $128 million for the twelve months ended July 2026 (IQVIA). Zyogreen is marketed and distributed in the U.S. by Sagent under an agreement with Provepharm, a global leader in medical and diagnostic dyes. Zyogreen is an optical imaging agent used in fluorescence-guided procedures and diagnostic imaging. Surgeons performing vascular, gastrointestinal, organ transplant, plastic, and reconstructive procedures – including minimally invasive surgery – as well as those visualizing extrahepatic biliary ducts, gynecologic oncologists performing lymphatic mapping in cervical and uterine cancer, and ophthalmologists performing angiography now have access to a ready-to-use ICG formulation. Unlike conventional ICG products, which are supplied as a lyophilized powder that must be reconstituted before administration, Zyogreen is supplied as a sterile solution with no reconstitution required. For visualization of extrahepatic biliary ducts, Zyogreen is indicated in adults and in pediatric patients from birth to less than 1 year of age and 6 years of age and older. "This launch represents another important milestone in Sagent's evolution as a specialty pharmaceutical company," said Vishy Chebrol, Chief Executive Officer of Sagent Pharmaceuticals. "Zyogreen brings the established clinical utility of indocyanine green together with the convenience of a ready-to-use formulation, and it adds another FDA-approved source of a product that surgical and imaging teams depend on. Through our partnership with Provepharm, we are working to strengthen the reliability of supply for the hospitals and health systems we serve and to support the growing use of fluorescence-guided imaging." "Zyogreen is a true innovation emerging from Provepharm's research and development expertise, introducing a ready-to-use formulation to fluorescence imaging," said Michel Feraud, chairman and founder of Provepharm. "Partnering with Sagent brings that innovation to hospitals and surgical teams across the United States, and reflects our long-term commitment to supporting healthcare professionals and the patients in their care." Zyogreen is the second Provepharm dye Sagent has brought to the U.S. market, joining Bludigo® (indigotindisulfonate sodium injection) , the first and only FDA-approved injectable indigo carmine diagnostic dye. Together, the two products establish Sagent's growing presence in surgical and diagnostic visualization and provide a strong foundation for continued growth in this evolving field. Zyogreen is available now through Sagent's nationwide distribution network. Important Safety Information Contraindications: Zyogreen is contraindicated in patients with a history of hypersensitivity to indocyanine green. Reactions have included anaphylaxis. Warnings and Precautions: Hypersensitivity reactions, including anaphylaxis, urticaria, and deaths due to anaphylaxis, have been reported following intravenous administration of indocyanine green, the active ingredient in Zyogreen. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions. Because Zyogreen contains sodium iodine, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Drug Interactions: Do not perform radioactive iodine uptake studies for at least one week following administration of Zyogreen. Adverse Reactions: The most common adverse reactions reported are anaphylaxis and urticaria. To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-800-625-1618 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information for complete indication and safety information. About Zyogreen® Zyogreen® (indocyanine green injection) is a sterile, ready-to-use optical imaging agent for intravenous or interstitial use. Zyogreen is indicated for fluorescence imaging of vessels, blood flow and tissue perfusion in adults and pediatric patients; fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older; fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer; and ophthalmic angiography in adults and pediatric patients. Please see full Prescribing Information for complete indication and safety information. About Sagent Pharmaceuticals Sagent Pharmaceuticals is a leading provider of generic and specialty pharmaceuticals serving hospitals, health systems, and healthcare providers throughout the United States. Through strategic partnerships, advanced drug delivery technologies, and a growing portfolio of differentiated products, Sagent is committed to delivering high-quality medicines that support patient care and improve healthcare delivery. Sagent is headquartered in Schaumburg, Illinois. For more information, visit . About Provepharm Provepharm is a pharmaceutical company specializing in the development of high-quality, effective and ready-to-use dyes designed to improve visualization and detection in clinical practice. With almost 30 years of expertise, our innovation is grounded in organic chemistry and advanced formulation technologies, ensuring the quality, performance and ease of use of our dyes in the operating room. Zyogreen® and Bludigo® are registered trademarks of Provepharm SAS. MEDIA CONTACT: Sagent Pharmaceuticals Jeff Greve EVP, Chief Financial Officer (312) 331-0050 jgreve@sagentpharma.com Jyothi Chaludavi Vice President, Business Development and Strategic Initiatives +91 73309-99114 jchaludavi@sagentpharma.com View original content to download multimedia: SOURCE Sagent Pharmaceuticals

上市批准

2026-09-22

·丹望医疗

药物研发中的肝毒性挑战：肝类器官模型质量控制与关键评价指标

药物性肝损伤是药物研发及临床应用过程中需要重点关注的安全性风险之一。肝脏承担药物代谢、解毒、蛋白合成及物质转运等多项重要生理功能，因此，体外模型能否有效重现这些功能，直接影响肝毒性评价结果的生物学相关性。传统动物模型受物种间代谢差异影响，对人体肝毒性的预测存在一定局限。随着非临床安全性评价逐步引入更加复杂的人源体外模型，肝类器官因能够在一定程度上重现人体肝脏的细胞组成和功能特征，正成为药物毒性评价的重要候选模型。 2024年，International Journal of Stem Cells 发表Guidelines for Manufacturing and Application of Organoids: Liver。该研究由韩国生命工学研究院（KRIBB）、汉阳大学医学院、韩国毒理学研究院（KIT）等机构研究人员共同完成，并获得韩国食品药品安全处（MFDS）2024年度项目资助。该论文围绕肝类器官的细胞来源、制备、质量评价、保存及毒性检测应用提出系统性建议，重点讨论如何通过标准化质控提高类器官在肝毒性评价中的重复性和可靠性。对于肝毒性研究而言，这一思路具有直接的实践意义。只有在模型自身的肝细胞组成、代谢能力和基础肝功能得到充分确认后，药物处理后观察到的变化才具有更可靠的解释。 △肝类器官的质控建议来源细胞肝类器官可来源于人体肝组织中的成体干细胞（human adult stem cells，hASCs），也可由人多能干细胞（human pluripotent stem cells，hPSCs）分化获得，其中包括诱导多能干细胞（iPSCs）和胚胎干细胞（ESCs）。不同细胞来源具有不同的培养方式、分化路径和细胞组成，因此，来源细胞质量是后续类器官功能稳定性的基础。论文提出，应对来源细胞进行充分评价，包括细胞在预定培养条件下的存活和增殖能力、细胞特征、纯度、遗传稳定性以及污染情况。 _ hASCs 来源的肝类器官 hPSCs 来源的肝类器官细胞来源肝组织 iPSCs；ESC 获取方式从肝样本分选 EpCAM⁺ 胆管细胞 iPSCs 可通过商业渠道获取，如干细胞库；也可通过体细胞重编程生成重编程不涉及重编程将 Yamanaka 因子引入体细胞，使其恢复至类似 ESC 的多能状态；体细胞包括皮肤成纤维细胞、血细胞、骨髓细胞、尿液来源体细胞关键标志物干细胞和肝祖细胞标记物：LGR5、CK19、SOX9 多能性标记物：NANOG、SOX2、OCT4 类器官生成添加细胞外基质和特异性生长因子，以 3D 方式生成由 hPSCs 分化生成；ESC 与 iPSC 适用相同质量标准分化潜能 EpCAM⁺ 细胞具双潜能，可分化为胆管细胞和肝细胞应分化为所有三个胚层：外胚层、中胚层、内胚层其他正常核型；无支原体污染正常核型；无支原体污染 △表1 来源细胞质控类器官尺寸和细胞组成类器官尺寸是三维模型标准化过程中不可忽视的参数。随着类器官体积增加，其中心区域可能受到氧气和营养物质扩散限制，并出现缺氧或坏死，从而影响基础细胞状态及药物响应。因此，尺寸也关系到药物暴露条件的一致性。类器官尺寸：针对肝毒性测试，建议hASC来源肝类器官的直径至少达到100 μm，同时每个类器官的细胞数应超过1,000个；对于hPSC来源肝类器官，建议直径控制在100～500 μm范围内，并同样要求每个类器官细胞数超过1,000个，hPSC设置500 μm的建议上限，主要考虑到尺寸过大可能造成营养和氧气灌注不足，并增加中心区域坏死风险。细胞组成：hASC来源肝类器官主要由肝细胞和胆管细胞组成；hPSC来源模型则具有更高的组成复杂性，可进一步包含肝星状细胞、肝窦内皮细胞及免疫细胞等。多细胞组成有助于提高模型的生理相关性，但对于以药物代谢和肝细胞损伤为主要研究目的的肝毒性评价，功能性肝细胞仍应构成主要细胞群体。肝类器官内肝细胞比例的定量评估通过使用流式细胞术测量ALB表达水平来确定。由于人肝组织通常由>70%的肝细胞组成，建议使用ALB表达水平>70%的类器官。类器官功能要求类器官肝脏特异性功能的质量要求：基本功能包括ALB和AAT的分泌。此外，肝类器官表现出产生尿素（蛋白质代谢的废物产物）和储存糖原的能力。ICG（ Indocyanine Green ，吲哚菁绿）的吸收和清除验证肝类器官解毒过程中的关键肝脏功能。此外，应评估动态胆汁产生和排泄、药物代谢酶的激活、外源化合物的代谢，以验证类器官的肝脏特异性功能。核型和身份确认：类器官与来源细胞（肝组织或iPSCs）应显示相同的短串联重复序列。对于肝类器官的长期维持，建议每20~30代分析一次染色体核型。质控监测：在定量标准（表2）中，建议对ALB分泌和CYP3A4活性进行批次毒性评估。其他定量和定性质量评估应在类器官初始质控时进行，此后建议每10~20代监测一次。 _ 方法评估标准肝脏特异性基因表达 PCR ALB、HNF4a、MDRs、BSEP、MRPs、CYP3A4、CYP1A2、CYP2C9、CYP2D6等肝细胞组成流式细胞术 >70%细胞表达ALB 药物代谢酶活性 CYP3A4活性利福平诱导处理48小时后>1.5倍 ALB合成 ELISA或LC-MS/MS >1 μg/24 h/10⁶细胞，ALB分泌水平 AAT合成 ELISA或LC-MS/MS >1 μg/24 h/10⁶细胞，AAT分泌水平尿素合成尿素测定或LC-MS/MS >1 μg/24 h/10⁶细胞，尿素分泌水平表2. 肝类器官评估的定量标准 ALB：白蛋白，AAT：α1-抗胰蛋白酶，PCR：聚合酶链反应，CYP：细胞色素P450，ELISA：酶联免疫吸附测定，LC-MS/MS：液相色谱-串联质谱。评价终点检测方法评估标准肝脏特异性标记物免疫染色、PCR ALB、HNF4a、MDRs、MRPs等阳性染色；药物代谢相关基因 PCR 诱导剂药物处理后CYP3A4、CYP1A2、CYP2C9等表达增加糖原储存 PAS染色 PAS阳性染色 ICG ICG染色 ICG的摄取和释放胆小管 CDFDA染色 CDFDA染色后观察到胆小管结构表3. 肝类器官评估的定性标准 ICG：吲哚菁绿，PCR：聚合酶链反应，PAS：过碘酸-雪夫，CDFDA：羧基荧光素二乙酸酯。类器官保存质控对于需要长期保存的类器官，冻存及后续复苏过程均应进行规范管理。复苏后，类器官的细胞活率应在70%以上；若未达到该标准，应考虑更换其他冻存批次。长期培养过程中还需持续监测微生物污染，尤其是支原体污染。为维持类器官培养体系的稳定性，建议每10～20代进行一次污染检测。伦理要求肝类器官研究应符合相关伦理和医学规范。人体肝组织的获取须基于供体知情同意，并在机构审查委员会（IRB）批准下开展。研究用组织应来源于手术切除或临床诊断性活检样本，并按照既定标准进行供体筛选。患者个人信息应采用编码和加密方式管理，仅限授权研究人员访问。受试者招募过程中，应充分保障其自主决定权和隐私，并加强对弱势受试者的保护。从胆管来源类器官到胎肝类器官肝组织来源类器官的建立经历了不同的技术路径。Hans Clevers团队早期研究通过成人肝脏胆管来源的双潜能祖细胞建立可长期扩增的类器官体系，并可进一步诱导获得具有肝细胞功能特征的细胞。2018年，Hans团队在 Cell 发表研究，建立了小鼠和人原代肝细胞的长期三维类器官培养体系，研究中建立的人胎肝细胞来源类器官（human fetal hepatocyte organoids）可支持肝细胞长期扩增，并在培养过程中保持一定的肝细胞形态、基因表达特征，并表现出白蛋白分泌等肝细胞功能特征，为人源肝细胞的体外扩增及功能研究提供了重要模型基础。在此基础上，Hans团队于2021年在 Nature Protocols 进一步发表人胎肝细胞类器官的建系、长期扩增及基因编辑方法，对该模型的建立和应用流程进行了系统化描述。在此基础上，Hans团队于2024年进一步对胎肝细胞类器官的成熟化条件进行了优化。成熟化培养后，类器官细胞呈现更典型的成熟肝细胞多边形形态，细胞体积及双核细胞比例增加；胎肝标志物AFP明显下降，而ALB蛋白特征更加突出。同时，多种CYP药物代谢酶及胆汁酸转运蛋白SLC10A1（NTCP）的表达升高，显示出更成熟的肝细胞表型及药物代谢相关特征。该研究进一步表明，胎肝细胞类器官兼具较好的扩增能力和进一步成熟化的潜力。对于肝毒性评价而言，通过成熟化培养提高药物代谢相关功能，有助于增强模型与实际应用需求的匹配度；同时，正式用于毒性检测前仍需结合ALB、CYP3A4活性及其他肝功能指标进行质量确认。这一模型的药物研发价值已经得到实际研究验证。2023年，Hans团队在 Nature Biotechnology 利用人胎肝细胞类器官建立脂肪变性模型，并进一步开展药物筛选，不仅筛选出能够改善脂肪变性的化合物，还显示不同遗传背景可能影响药物响应，证明胎肝类器官能够用于疾病建模、靶点发现以及化合物筛选等药物研发环节。丹望医疗肝类器官丹望医疗基于其联合创始人 Hans Clevers 教授关于胎肝类器官的研究，优化了胎肝类器官培养条件，使其在快速增殖、长期传代的同时，保持肝细胞功能，可基于该模型开展肝毒性、脂肪肝等研究，针对不同药物及研究目的，可结合类器官形态、肝功能指标、药物代谢酶活性及毒性检测等构建相应的评价方案，为药物早期安全性评价及肝毒性研究提供人源体外模型支持。胎肝类器官呈现典型的实质类器官形态，并在体外可以实现长期扩增胎肝类器官病理鉴定胎肝类器官进行特征蛋白鉴定，发现胎肝类器官特异性表达肝细胞特征蛋白ALB及HNF4A，此外胎肝类器官还表达多种功能蛋白，例如GS：肝细胞谷氨酰胺合成酶，与谷氨酸代谢相关 HAL：组氨酸解氨酶，与组氨酸代谢相关 MRP2：肝细胞胆汁代谢功能中胆汁酸转运的典型marker值得注意的是胎肝类器官系统中胆管特征蛋白CK19没有明显表达，提示构建的胎肝类器官主要由肝细胞构成，同时也验证了Hans Clevers教授的相关研究结果。胎肝类器官转录组测序我们将不同胎龄的胎肝类器官收集，鉴定了相关CYP基因的表达水平，从bulk RNA-seq结果可见胎肝类器官表达多种肝细胞重要的CYP代谢酶基因。胎肝类器官具有成熟肝细胞功能我们验证了胎肝类器官的核心功能：肝细胞具有白蛋白分泌(A)、尿素合成(B)、糖原合成(D)、脂质吸收(E)、胆汁酸转运(F)等功能。其中白蛋白分泌可达白蛋白分泌可达30–50 μg/百万细胞/天，与成体原代肝细胞相当，尿素合成水平可达百微克级别，与原代肝细胞相当；此外胎肝类器官还具有A1AT（或称AAT）酶分泌(C)的功能。药物肝毒性检测-典型药物响应曲线我们根据FDA报道的肝毒性药物随机挑选7个化合物用于检测胎肝类器官评价药物肝毒性的可行性。结果表明胎肝类器官经过肝毒性药物处理，出现明显细胞活力下降表型。而无肝毒性药物则不会明显改变细胞活力，表明胎肝类器官具有良好评价药物肝毒性的潜力。结构类似药物肝毒性差异检测我们根据哈佛大学团队报道的肝毒性药物随机挑选3对结构类似而肝毒性存在明显差异的小分子药物用于鉴定胎肝类器官评价药物肝毒性强弱的潜力。结果显示经过肝毒性药物处理后胎肝类器官活力明显下降，而结构类似无肝毒性药物则无明显活力影响。该结果表明胎肝类器官具有区分结构类似小分子药物肝毒性强弱的能力。肝毒性测试：胎肝类器官VS原代肝细胞为进一步比较胎肝类器官与原代肝细胞系统评价药物肝毒性的潜力。我们获取了哈佛大学团队的26种小分子药物，利用胎肝类器官评价其潜在的药物肝毒性。结果表明胎肝类器官在肝毒性药物的准确率及特异性均与原代肝细胞系统相当，证明其良好的肝毒性评价能力。参考文献： Moon HR, Mun SJ, Kim TH, et al. Guidelines for Manufacturing and Application of Organoids: Liver. International Journal of Stem Cells. 2024;17(2):120–129. Huch M, Gehart H, van Boxtel R, et al. Long-term culture of genome-stable bipotent stem cells from adult human liver. Cell. 2015;160(1–2):299–312. doi:10.1016/j.cell.2014.11.050. Hu H, Gehart H, Artegiani B, et al. Long-Term Expansion of Functional Mouse and Human Hepatocytes as 3D Organoids. Cell. 2018;175(6):1591–1606.e19. Hendriks D, Artegiani B, Hu H, et al. Establishment of human fetal hepatocyte organoids and CRISPR–Cas9-based gene knockin and knockout in organoid cultures from human liver. Nature Protocols. 2021;16:182–217. Ewart L, Apostolou A, Briggs SA, et al. Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Commun Med (Lond). 2022;2(1): 154. Published 2022 Dec 6. 欢迎各位咨询 👇 D1Med小助手微信公众号小红书官方交流 🌸欢迎加入丹望类器官产品与服务交流群，本群将聚焦于技术交流、资源互通、动态速递以及合作对接。 👏本群面向科研人员、临床医生以及药企从业者等多群体，致力于打造从“科研-药企-临床”的全链条服务。 🎁现在加群，更可参与抽取精美礼品哦~ ⌛️如遇二维码失效，请联系丹望医疗小助手进群哦~ 丹望类器官产品与服务交流8群（该二维码9月29日前失效）关于丹望医疗 D1Med 作为中国类器官领域的独角兽，丹望医疗已发展成为全球领先的类器官疾病模型和类器官芯片的高新技术企业，致力于将前沿类器官技术应用于药物开发、疾病诊疗、再生医学等多个前沿领域，助力生物医药行业迭代高速发展。公司依托强大的技术自主研发实力，建立全球规模最大、覆盖全面的类器官模型库，涵盖肺、乳腺、胃、肠、心脏、神经、肝脏皮肤等多个正常模型及肿瘤类器官模型，为药物开发和科学研究提供了坚实的模型支撑。丹望医疗构建了从模型建立、药效评估、毒理测试和细胞治疗评估等完善的科研服务体系和药企临床前CRO体系，凭借专业的技术能力和优质的模型库，已为国内上百家药企和医院提供精准、高效的服务，成功辅助多家药企完成IND申报，彰显了龙头企业的技术担当与产业影响力。邮箱｜service@d1med.com 官网｜www.d1med.com END

100 项与吲哚菁绿相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01342	吲哚菁绿	V04CX01	DB09374

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
胆管疾病	美国	Novadaq Technologies ULC	2018-11-21
宫颈癌	美国	Novadaq Technologies ULC	2018-11-21
子宫癌	美国	Novadaq Technologies ULC	2018-11-21
血管疾病	美国	Novadaq Technologies ULC	2018-11-21
乳腺癌	日本	Daiichi Sankyo Co., Ltd.	2009-09-18
黑色素瘤	日本	Daiichi Sankyo Co., Ltd.	2009-09-18
造影剂	美国	Renew Pharmaceuticals Ltd.	1959-02-09

未上市

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适应症	最高研发状态	国家/地区	公司	日期
急性肝功能衰竭	临床3期	美国	CardioX, Inc.	2015-11-01
结肠癌	临床2期	美国	University of Pennsylvania	2024-08-14
食管癌	临床2期	美国	University of Pennsylvania	2024-08-14
胶质瘤	临床2期	美国	University of Pennsylvania	2024-08-14
脑膜瘤	临床2期	美国	University of Pennsylvania	2024-08-14
非小细胞肺癌	临床2期	美国	University of Pennsylvania	2024-08-14
卵巢癌	临床2期	美国	University of Pennsylvania	2024-08-14
胰腺癌	临床2期	美国	University of Pennsylvania	2024-08-14
甲状旁腺腺瘤	临床2期	美国	University of Pennsylvania	2024-08-14
前列腺癌	临床2期	美国	University of Pennsylvania	2024-08-14

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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


NCT03584633 (CTgov)	临床4期	淋巴水肿	9	Indocyanine green	襯簾齋製夢蓋鏇構窪襯(淵壓築願鏇艱糧衊積願) = 艱憲糧鑰網繭簾鏇選糧壓淵願膚窪獵艱鹹構網 (顧憲壓網鏇遞襯憲製齋, 1) 更多	-	2024-12-27
NCT04534816 (Pubmed \| Int J Surg)	N/A	贯通性创伤	-	Indocyanine green (ICG-FA)	齋鹽鏇夢壓餘鏇窪糧夢(積觸顧衊簾簾顧鹽遞積) = 顧壓壓鬱鑰艱顧蓋繭衊築夢範醖鑰餘製糧遞鬱 (壓願網窪鏇糧夢鹽鑰鹽 ) 更多	积极	2024-12-01
NCT04534816 (Pubmed \| Int J Surg)	N/A	贯通性创伤	-	Indocyanine green (Control (no ICG-FA))	醖鏇積獵觸觸艱願簾選(製廠艱糧膚廠壓顧選獵) = 膚鏇襯襯繭築製鏇簾憲鑰積選鬱餘鑰築鬱艱蓋 (鬱製壓齋網醖願製遞襯 ) 更多	积极	2024-12-01
NCT05859971 (CTgov)	早期临床1期	乳腺癌	10	isosulfan blue+SLN mapping with ICG fluorescence using the Asimov Platform	獵遞艱窪鹽積鹹餘衊鑰 = 憲齋願顧範餘齋餘簾構範餘鹹蓋膚遞構窪選襯 (築鹹觸顧繭壓憲構獵衊, 製衊衊選餘顧鏇鑰淵鹹 ~ 膚選鹽憲艱鏇襯製餘築) 更多	-	2024-08-15
NCT01034670 (CTgov)	N/A	胃肠道间质瘤 \| 胃癌	3	fluorescent Peptide+fluorescein+Indocyanine green	積淵鹹積鏇醖壓襯構鹹 = 齋鹽廠艱衊繭觸鹹鏇範餘襯選築窪遞獵醖繭鹽 (餘築鬱積觸築齋壓襯獵, 糧鹹願網憲襯範構窪願 ~ 簾繭艱鏇艱選網壓憲蓋) 更多	-	2024-06-26
NCT05094102 (CTgov)	N/A	乳腺癌 \| 淋巴水肿	9	OnLume Imaging System+Indocyanine green	淵蓋淵範衊鹹齋衊遞齋 = 襯衊糧壓膚鹹顧積築鬱憲艱網鹹鹹選築繭網窪 (積餘襯顧遞醖衊鏇顧獵, 鹽鹽顧淵鏇願憲築餘鑰 ~ 鹽構製顧夢網淵壓蓋顧) 更多	-	2024-05-23
NCT04511026 (CTgov)	临床2期	子宫内膜癌	6	Single Photon Emission Computed Tomography (SPECT)+Lymphoseek+Indocyanine Green (ICG)	淵壓鹹夢鹹蓋鏇鑰鏇襯 = 齋壓糧製壓選構襯鏇廠積壓膚蓋艱顧衊鹽襯觸 (夢製鹹衊憲鏇繭壓餘範, 壓鑰蓋窪淵積膚夢簾餘 ~ 襯構構艱觸鑰醖齋遞積) 更多	-	2023-10-11
NCT04084067 (Pubmed \| Pediatr Blood Cancer)	临床1期	实体瘤	12	Indocyanine green (ICG)	鏇築簾網願夢餘積繭願(鹹範餘願襯積膚憲蓋壓) = ICG guidance failed to localize pulmonary metastases in five (42%) patients who had inflammatory myofibroblastic tumor, atypical cartilaginous tumor, neuroblastoma, adrenocortical carcinoma, or papillary thyroid carcinoma 衊獵簾壓觸憲積製膚構 (鏇簾醖構觸窪醖願醖獵 )	不佳	2023-10-01
NCT03200704 (FILM-B, CTgov)	临床3期	乳腺癌	152	Tc-99m radioactive colloid and Gamma Probe+IC2000 and SPY-PHI	夢觸獵廠鑰窪齋蓋淵淵 = 壓獵糧膚膚鹽淵觸鹹淵夢鑰鹽齋觸艱壓繭膚鏇 (範醖繭鑰鏇鬱膚艱膚鏇, 製鏇簾窪繭獵繭觸繭餘 ~ 艱壓餘網壓衊製簾觸襯) 更多	-	2023-09-21
NCT04942665 (ICG, CTgov)	临床2期	肝细胞癌 \| 肝转移 \| 胆囊炎	60	PINPOINT Endoscopic Fluorescence+Indocyanine green (Low Dose)	選顧糧鏇糧艱獵遞範窪(遞製膚範壓獵網願鬱願) = 願廠艱願遞壓窪繭積襯蓋淵網獵壓淵鑰壓製願 (顧夢齋繭壓憲蓋簾鹽齋, 獵範鑰蓋憲鹽淵窪廠夢 ~ 範膚蓋鹹選鑰壓衊網憲) 更多	-	2023-08-30
NCT04942665 (ICG, CTgov)	临床2期	肝细胞癌 \| 肝转移 \| 胆囊炎	60	PINPOINT Endoscopic Fluorescence+Indocyanine green (Standard Dose)	選顧糧鏇糧艱獵遞範窪(遞製膚範壓獵網願鬱願) = 艱憲衊願鏇鏇簾齋構願蓋淵網獵壓淵鑰壓製願 (顧夢齋繭壓憲蓋簾鹽齋, 構願醖蓋網築顧構鑰壓 ~ 淵遞夢憲鹹齋構餘願鏇) 更多	-	2023-08-30
NCT03294330 (SPYX, CTgov)	临床3期	皮肤黑色素瘤 \| 乳腺癌	35	IC-Green KIT	蓋艱簾衊製鹽憲淵淵鬱 = 襯鑰衊積壓觸窪鏇製繭網製窪窪壓鬱願鑰選齋 (醖艱襯夢夢膚顧顧鬱艱, 糧選糧襯鑰廠遞願製網 ~ 餘網鹹膚窪夢鏇獵襯網) 更多	-	2023-01-12