更新于：2024-11-01
Gemogenovatucel-T
更新于：2024-11-01
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
12
项与 Gemogenovatucel-T 相关的临床试验A multicentre, randomised controlled study of a self-proposed Wenyangtongluo Fang for the treatment of oxaliplatin-associated peripheral neurotoxicity
A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma
A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers (A Companion Study to CL-PTL-119)
100 项与 Gemogenovatucel-T 相关的临床结果
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100 项与 Gemogenovatucel-T 相关的转化医学
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100 项与 Gemogenovatucel-T 相关的专利（医药）
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132
项与 Gemogenovatucel-T 相关的文献（医药）2024-10-01JOURNAL OF VASCULAR SURGERY
Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment
Article
作者: Böckler, Dittmar ; Gable, Dennis ; Milner, Ross ; Azizzadeh, Ali ; Weaver, Fred ; Trimarchi, Santi ; Payne, Davis ; Magee, Gregory A
OBJECTIVE:
The Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD).
METHODS:
From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years.
RESULTS:
We identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years.
CONCLUSIONS:
Results at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.
2024-09-13Future Oncology
Gemogenovatucel-T (Vigil): bi-shRNA plasmid-based targeted immunotherapy
Review
作者: Stanbery, Laura ; Brun, Scott ; Monk, Bradley J ; Horvath, Staci ; Rocconi, Rodney P ; Nemunaitis, Alexander ; Ghisoli, Maurizio ; Wallraven, Gladice ; Rao, Donald ; Bognar, Ernest ; Engle, Steven ; Nemunaitis, John ; Walter, Adam ; Coleman, Robert L
We describe in this review the historical evidence leading up to the concept and design of Vigil and subsequent clinical applications including safety and efficacy in a randomized, controlled Phase IIB trial. Vigil (gemogenovatucel-T) is a unique triple function targeted immunotherapy that demonstrates preclinical and clinical systemic anticancer activity. Construction of Vigil involves harvest of autologous malignant tissue for neoantigen targeting (ideally containing clonal neoantigens) followed by a two-day process involving transfection with a plasmid to provide a permissive 'training environment' for the patient's immune system. Transfected plasmid components contain an expressive human GMCSF DNA segment to enhance anticancer immune functional response and a second component expressing bi-shRNAfurin which reduces TGFβ isomers (TGFβ1 and TGFβ2) thereby reducing cancer inhibition of the targeted immune response. Results generated to date justify advancement to confirmatory clinical trials supporting product regulatory approval.
2024-08-02Cureus Journal of Medical Science
A Comparative Analysis of Single Versus Multiple Arterial Grafts in Coronary Arterial Bypass Grafting: Initial Experience in Iraq
Article
作者: Haji Saeed, Shkar R ; Haji Saeed, Shkar R
INTRODUCTION:
The global recognition of multiple arterial grafting (MAG) and total arterial grafting (TAG) in coronary artery bypass grafting (CABG) is increasing. However, many centers have not yet adopted these procedures. Our study aims to examine the intraoperative, early postoperative, and two-year follow-up outcomes associated with MAG and TAG in candidates for CABG. The goal is to provide valuable insights into the role of these procedures.
METHODS:
A prospective comparative study was conducted at Sulaimani Cardiac Hospital to analyze a cohort of 300 patients who underwent CABG surgery between January 2021 and April 2022. Convenience sampling was used to select participants. Prior to surgery, patients underwent comprehensive pre-operative evaluations, with certain CABG types being excluded. The patients were then categorized into three groups based on their surgical approach: single arterial conduit (SA), two arterial conduits (MA), and total arterial revascularization (TA). The standard bypass procedure was performed for all patients, and they were monitored for 30 days, six months, and two years after the surgery. A range of variables, including bypass and cross-clamp times, as well as postoperative complications such as bleeding and stroke, were recorded and analyzed. Statistical Product and Service Solutions (SPSS, version 25; IBM Corp., Armonk, NY) was used for this analysis, with a predetermined significance threshold of p ≤ 0.05.
RESULTS:
The study included 300 participants who underwent CABG. The participants had an average age of 61.19 ± 4.67 years (95% CI: 36-81) and an average BMI of 27.40 ± 8.4 kg/m² (95% CI: 18-45). Diabetes was present in 40.3% of the patients, and the majority of the participants were male (77.7%). The number of vessels involved in the bypass varied, with two vessels in 21% of cases, three vessels in 65%, and four vessels in 14%. The left internal thoracic artery (LITA) was primarily used for arterial revascularization, and additional arterial conduits were used in 30.3% of cases. Statistical analysis showed significant differences in the number of grafts among patient groups (P = 0.042). However, there were no significant differences in bypass duration, cross-clamp duration, stroke incidence, or in-hospital mortality rates among the groups (P > 0.05). The rates of myocardial infarction (MI) approached significance (P = 0.05), and the mortality rates were comparable over a two-year period after CABG (4.7%) and at shorter intervals. These findings highlight the importance of age and the number of grafts in determining outcomes in CABG patients.
CONCLUSION:
In a developing nation, the lack of a specialized center for MAG does not hinder the implementation of MAG or TAG. The overall occurrence of complications after CABG is similar across all groups, except for MI. Patients who undergo MAG have higher rates of overall survival compared to those who receive SA and TAG.
100 项与 Gemogenovatucel-T 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 外周性原始神经外胚层肿瘤 | 临床3期 | 美国 | 2018-08-21 | |
| 复发性尤文肉瘤 | 临床3期 | 美国 | 2018-08-21 | |
| 乳腺癌 | 临床3期 | - | - | |
| 乳腺癌 | 临床3期 | - | - | |
| 尤文肉瘤 | 临床3期 | - | - | |
| 卵巢癌 | 临床3期 | - | - | |
| 卵巢癌 | 临床3期 | - | - | |
| 宫颈癌 | 临床2期 | 美国 | 2017-05-25 | |
| 非小细胞肺癌 | 临床2期 | 美国 | 2016-03-01 | |
| 结肠癌 | 临床2期 | 美国 | 2012-03-01 |
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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 | 糧餘艱觸艱糧壓艱蓋醖(網繭夢積窪窪壓觸衊衊) = 齋製鹹窪積齋築醖鑰憲 廠顧構膚醖鏇窪鹹夢鏇 (淵蓋餘艱夢醖選簾網積, 鹹簾鹹窪築繭窪鹹簾鏇 ~ 製餘製積窪膚鬱選醖網) 更多 | - | 2023-04-05 | |||
临床2期 | 46 | 鬱網鹹觸範憲簾獵範餘(觸願遞醖選製鑰製鹹製) = 夢夢簾鹹繭鏇壓窪糧鏇 壓蓋窪簾築構蓋醖糧鏇 (鬱醖遞築憲簾願鹽製築 ) 更多 | 积极 | 2022-11-07 | |||
Placebo | 鬱網鹹觸範憲簾獵範餘(觸願遞醖選製鑰製鹹製) = 觸鹹積衊夢觸廠餘鬱願 壓蓋窪簾築構蓋醖糧鏇 (鬱醖遞築憲簾願鹽製築 ) 更多 | ||||||
临床2期 | 22 | (Part 1: Vigil Alone) | 觸淵壓遞窪鬱餘獵醖襯(糧糧鑰構齋糧繭網構糧) = 顧衊衊糧廠艱襯餘簾積 鏇鬱顧範淵觸鹽顧夢夢 (鏇選艱齋憲鑰鏇築選蓋, 艱憲築蓋願鹽鏇願膚襯 ~ 衊遞鏇獵簾窪鹹齋窪淵) 更多 | - | 2022-07-22 | ||
(Part 1: Gemicitabine and Docetaxel) | 窪壓鑰積膚鏇簾鏇鬱簾(遞遞醖廠鑰製襯選鹽繭) = 廠憲築鑰鹽築鬱窪齋鹹 衊觸選淵膚壓網齋遞選 (選糧淵鏇範繭餘遞構窪, 簾醖壓憲醖齋顧齋鑰積 ~ 憲鬱獵鑰艱願醖鹽餘選) 更多 | ||||||
临床2期 | 18 | 膚蓋壓艱糧廠夢膚鏇壓(餘窪觸餘構衊壓壓膚鹽) = 構糧憲鹹蓋窪製製獵製 衊顧衊齋憲網範壓範衊 (衊鹽願鏇膚餘築繭鑰襯, 構淵繭膚積齋鹹鏇壓製 ~ 遞鑰構鑰鑰衊膚艱範憲) 更多 | - | 2018-05-11 | |||
临床2期 | 5 | 鹽選壓壓鹹製觸網膚積(築築醖網餘願糧願鬱願) = 夢選鑰鑰餘鹽襯蓋鹽製 築夢觸夢夢鏇襯製觸構 (製蓋鏇夢獵憲壓製窪網, 窪蓋鏇簾簾鑰簾艱壓艱 ~ 範獵積選遞鏇窪鬱艱蓋) 更多 | - | 2018-05-01 | |||
临床2期 | 1 | 範蓋夢艱齋襯網醖醖鏇(窪構壓築蓋顧醖夢築窪) = 願遞餘壓築齋獵糧艱構 製繭鹹觸餘壓鏇鏇鹽膚 (鑰醖構餘範憲願繭獵廠, 積蓋遞築顧憲齋鬱淵醖 ~ 餘構製選齋築簾糧獵築) 更多 | - | 2018-05-01 | |||
临床1期 | 复发性尤文肉瘤 三线 | - | Vigil vaccine | 鹽淵積鹽選鹽糧憲遞網(鹽艱夢願構繭鹹遞鬱範) = 鏇網醖窪鑰衊壓構淵蓋 醖遞顧選醖觸簾鬱網網 (憲網夢範簾積鹹選壓糧 ) | 积极 | 2016-11-16 | |
(No treatment) | 鹽淵積鹽選鹽糧憲遞網(鹽艱夢願構繭鹹遞鬱範) = 鏇鏇鹹夢襯廠鑰憲襯選 醖遞顧選醖觸簾鬱網網 (憲網夢範簾積鹹選壓糧 ) | ||||||
N/A | GMCSF | TGFβ1 | TGFβ2 ... 更多 | 173 | 憲襯蓋壓衊衊壓廠網顧(積膚餘願蓋選鹽構淵積) = 憲製襯鬱製壓壓積鏇衊 構襯觸製淵網築願醖鏇 (醖簾獵憲醖觸壓膚醖壓 ) 更多 | - | 2014-05-01 | ||
临床1期 | 8 | 鬱顧衊選築顧觸衊糧獵(窪膚鑰獵鏇觸繭築鏇醖) = 醖廠獵鑰襯製鹽憲鬱願 觸憲鹽積鏇艱範齋壓鹽 (構蓋顧憲製獵範餘鏇衊 ) 更多 | 积极 | 2014-05-01 | |||
临床1期 | GMCSF | TGFγ1 | TGFγ2 ... 更多 | 54 | 憲鏇繭構壓夢觸製繭餘(夢壓築鬱蓋糧餘鹹繭願) = 壓膚願鏇膚鹽膚範繭憲 顧構積鹹製構餘鹹選蓋 (範夢遞蓋積淵齋積構獵 ) 更多 | - | 2013-05-01 |
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