HP-802247(HP-802247) - _专利_临床

概要

基本信息

药物类型

细胞疗法

别名

Allogeneic human skin replacement Smith Nephew Biotherapeutics、DFB Healthpoint allogeneic human skin replacement、Human skin replacement Smith Nephew Biotherapeutics

+ [2]

靶点-

作用方式-

作用机制

Fibrinogen replacements(纤维蛋白原替代物)、组织替代物

治疗领域

皮肤和肌肉骨骼疾病其他疾病

在研适应症-

非在研适应症

下肢溃疡创伤和损伤

原研机构

Healthpoint Ltd.

在研机构-

非在研机构

Smith & Nephew Orthopaedics Ltd.

最高研发阶段终止临床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

11

项与 HP-802247 相关的临床试验

NCT02154087

/ Terminated临床2期

A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

开始日期2014-07-01

申办/合作机构

HealthPoint

NCT01853384

/ Terminated临床3期

A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

开始日期2013-11-01

申办/合作机构

HealthPoint

EUCTR2013-000949-39-BE

/ Not yet recruiting临床3期

An Observational Study Providing 12 Months of Safety Follow-Up from First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)

开始日期2013-09-20

申办/合作机构

Smith & Nephew, Inc. (Canada)

100 项与 HP-802247 相关的临床结果

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100 项与 HP-802247 相关的转化医学

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100 项与 HP-802247 相关的专利（医药）

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7

项与 HP-802247 相关的文献（医药）

2019-12-01·Annals of Plastic Surgery4区 · 医学

Cell-Based Therapies for Chronic Wounds Tested in Clinical Studies

4区 · 医学

Review

作者: Siemionow, Maria ; Krzyżanowska, Marta ; Domaszewska-Szostek, Anna

IntroductionTransplantation of the keratinocytes, fibroblasts, bone marrow, and adipose tissue–derived mesenchymal stem cells may improve chronic wound healing by delivery of different cytokines, chemokines, and growth factors, which play an essential role in wound healing. The purposes of this review were to check which cell lines are potentially beneficial in enhancement of wound healing and to describe the safety and efficacy of cell therapies in the clinical treatment of chronic wounds, as well as to summarize the pertinent literature and research progress in this field.MethodsPubMed search engine and ClinicalTrials.gov were used to analyze the available data on cell therapies applied in treatment of chronic wound. The analysis included 51 articles, assessing the use of keratinocytes (10), fibroblasts (7), keratinocytes and fibroblasts (10), bone marrow–derived cells (20), and adipose tissue cells (4). Studies on the cell-based products that are currently available on the market (Dermagraft, EpiDex, Apligraf, and HP802-247) were also included, with majority of reports found on fibroblasts and keratinocytes studies.ResultsCell-based therapies have a great potential to improve wound healing without major surgical procedures and donor-site morbidity. There is, however, a lack of guidelines on how the age of the patients, the general health conditions, and the coexistence of different diseases may affect the success of these therapies. Further studies are needed to determine the fate of transplanted cells and the number of cells required to obtain optimal effects and outcomes.ConclusionsDespite many promising clinical trials on application of various stem cell–based therapies for treatment of chronic wounds, there is still a need for multicenter comparative studies assessing the dose response and the cell source response on the efficacy of chronic wound healing.

2017-11-01·Journal of Vascular Surgery: Venous and Lymphatic Disorders3区 · 医学

Baseline factors affecting closure of venous leg ulcers

3区 · 医学

Article

作者: Sven Quist ; Lajos Kemeny ; Kenneth K. Shimozaki ; Yadwinder S. Dhillon ; Tomasz Zubilewicz ; Thomas Ruzicka ; Travis A. Motley ; Perry V. Mayer ; Caesar A. Anderson ; Kenneth B. Deck ; Paul B. Rock ; Alexander M. Reyzelman ; Petra Cetkovska ; Michael F. Moore ; Herbert B. Slade ; Lawrence Lavery ; Csaba Hajdu ; Stephanie C.S. Wu ; Wolfgang Vanscheidt ; Laszlo Lauf ; Peter F. Lawrence ; Alik Farber ; Olga Filipovska ; Charles A. Andersen ; Robert S. Kirsner ; Ian L. Gordon ; Dean Vayser ; Jaime E. Dickerson ; Jacek Mikosinski ; Eva Remenyik ; Douglas B. Hood ; D. Innes Cargill ; Tomasz Grzela ; Shawn M. Cazzell ; Radka Zimolova ; Jodi Walters ; J. Randolph Clements ; Vincent Giacalone ; Astrid Matejkova ; Joseph Cavorsi ; Emily A. Cook ; Juan C. Jimenez ; Eliot N. Mostow ; Petr Arenberger ; Michael Weichenthal ; John Tassone ; Steffen Emmert ; Marc A. Despatis ; Mher Vartivarian ; Robert D. Galiano ; Tobias George ; Bernhard Homey ; Karry Ann Shebetka ; Joachim Dissemond ; Holger Lawall ; Robert Galiano ; Pawel Swiercz ; Arlette De Conninck ; Sabine Eming ; Hilde Beele ; Michael M. Molyneaux ; Zbigniew Rybak ; David Stuchlik ; Robert G. Frykberg ; Istvan Varkonyi ; Roland Aschoff ; Joel J. Gagnon ; Edina Nemes ; Noemi Bakos ; Cyaandi Dove ; Michael Juenger ; Carl Van Gils ; An Bervoets ; Rita Rez ; Matthias Augustin ; Krystyna Twardowska-Saucha ; William A. Marston ; Jason R. Hanft ; Marek Kotala ; Thomas Horn ; Marian Simka ; George L. Enriquez ; Vladimir Vasku ; Marcin Malka ; Vera Pavlasova ; Markus Stuecker ; Paul J. Kim ; John C. Lantis ; David H. Keast ; Sabine A. Eming ; William J. Ennis ; Jonathan M. Zenilman

OBJECTIVEThe objective of this study was to characterize factors associated with closure of venous leg ulcers (VLUs) in a pooled analysis of subjects from three randomized clinical trials.METHODSClosure of VLUs after treatment with HP802-247, an allogeneic living cell therapy consisting of growth-arrested human keratinocytes and fibroblasts, vs standard therapy with compression bandaging was evaluated in three phase 3 clinical trials of similar design. Two trials enrolled subjects with VLUs ranging from 2 cm² to 12 cm² in area with 12-week treatment periods; the third trial enrolled subjects with VLUs between >12 cm² and ≤36 cm² with a 16-week treatment period. The first trial went to completion but failed to demonstrate a benefit to therapy with HP802-247 compared with placebo, and because of this, the remaining trials were terminated before completion. On the basis of no differences in outcomes between groups, subjects from both HP802-247 and control groups were pooled across all three studies. Cox proportional hazards regression analysis was employed to evaluate factors associated with VLU closure.RESULTSThis analysis included data from 716 subjects with VLU. Factors evaluated for association with healing included age, gender, race, diabetes, glycated hemoglobin level, body mass index, treatment (HP802-247 vs compression alone), and ulcer characteristics including location and area and duration at baseline. In an initial model including all of these putative factors, the following were significant at the P < .10 level: diagnosis of diabetes mellitus, gender, wound location (ankle or leg), baseline wound area, and wound duration at baseline. In a final model including only these factors, all but diabetes mellitus were significant at the P < .05 level. Effect sizes were as follows (hazard ratio [95% confidence interval]): female gender (1.384 [1.134-1.690]), wound location on the leg (1.490 [1.187-1.871]), smaller wound area at baseline (0.907 [0.887-0.927]), and shorter wound duration at baseline (0.971 [0.955-0.987]).CONCLUSIONSFactors associated with VLU lesions including location, area, and duration were important predictors of healing. Women were more likely than men to achieve wound closure. Factors including body mass index, the presence of diabetes mellitus, and higher concentrations of glycated hemoglobin were not significant independent predictors of wound closure in this analysis.

2013-09-01·Wound Repair and Regeneration3区 · 医学

Durability of healing from spray‐applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: A 6‐month follow‐up

3区 · 医学

Article

作者: Slade, Herbert B. ; Dickerson, Jaime E. ; Lee, Tommy D. ; Marston, William A. ; Snyder, Robert J. ; Cargill, D. Innes ; Zhang, Yuxin ; Kirsner, Robert S.

AbstractPatients who participated in a Phase 2 trial of HP802‐247 for venous leg ulcers were invited to participate in this 24‐week follow‐up study to assess the durability of healing, document additional ulcer closures, and evaluate posttreatment safety. Consent was given by 90% (206/228), with 80% (183/228) completing all visits. Blinding was retained from the previous trial in which subjects had been randomized to vehicle or one of four cell therapy regimens. Visits were every 8 weeks. Among the 183 subjects, 43% (21/49) previously treated with cells and entering follow‐up with an open wound achieved closure, compared with 35% (7/20) previously treated with vehicle, while 10% (11/106) and 17% (3/18), respectively, experienced reopening of a previously closed wound. Subjects previously treated with cells closed more open wounds than those previously treated with vehicle (OR 1.39, 95% CI 0.47–4.10; p = 0.739), and less subjects with a previously closed wound reopened (OR 0.65, CI 0.16–2.60; p = 0.821); however, these findings were not statistically significant. At the final visit, the difference in proportion of subjects with wounds closed continued to favor the best dose from the prior trial (83% closed vs. 58%, delta 25%). Follow‐up beyond 12 weeks is necessary to evaluate the full benefit of this therapy, as treatment with cells may provide stimulus toward healing that persists for up to several weeks following the last application. The results show that the greater proportional benefit achieved by HP802‐247 relative to standard care after 12 weeks of treatment persists over a meaningful timeframe.

100 项与 HP-802247 相关的药物交易

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研发状态

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
下肢溃疡	临床3期	加拿大	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	德国	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	比利时	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	匈牙利	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	波兰	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	捷克	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	美国	Smith & Nephew Orthopaedics Ltd.	-
下肢溃疡	临床3期	波多黎各	Smith & Nephew Orthopaedics Ltd.	-
创伤和损伤	临床3期	美国	Smith & Nephew Orthopaedics Ltd.	-

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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


NCT01737762 (CTgov)	临床3期	静脉曲张溃疡	155	HP802-247 (HP802-247)	簾艱壓淵鑰網鹹製衊蓋(獵餘構願糧觸襯範構醖) = 醖鏇鹽網蓋顧選構醖製膚網範遞範壓簾繭網範 (淵襯鏇鹹鹽淵廠壓範餘, 選鹽鬱艱範膚蓋獵艱窪 ~ 淵遞製願鬱積憲膚憲衊) 更多	-	2017-07-26
				Vehicle (Vehicle)	簾艱壓淵鑰網鹹製衊蓋(獵餘構願糧觸襯範構醖) = 鏇網艱繭獵壓蓋夢簾憲膚網範遞範壓簾繭網範 (淵襯鏇鹹鹽淵廠壓範餘, 醖膚範獵餘襯範鬱艱淵 ~ 壓觸積鹽餘鑰鹽餘餘獵) 更多
NCT01359735 (CTgov)	临床2期	皮肤肿瘤	8	HP802-247 (HP802-247)	繭憲簾醖淵簾構廠觸願(壓鑰窪積製鹽獵鏇鹽鏇) = 願艱範範築壓醖蓋窪範窪積顧齋遞廠遞獵襯醖 (獵鹹選襯網壓鬱鏇製夢, 蓋構鏇襯觸齋顧艱醖構 ~ 築觸壓醖鏇襯觸膚鹹簾) 更多	-	2017-06-29
				Bacitracin Ointment (Bacitracin Ointment)	繭憲簾醖淵簾構廠觸願(壓鑰窪積製鹽獵鏇鹽鏇) = 獵襯廠範襯繭醖衊繭鑰窪積顧齋遞廠遞獵襯醖 (獵鹹選襯網壓鬱鏇製夢, 艱範鹹蓋製繭鏇鹹願獵 ~ 觸獵鏇憲獵製鹹鬱觸鏇) 更多
NCT02154087 (MOA 034, CTgov)	临床2期	静脉曲张溃疡	1	HP802-247	繭積鏇構選繭夢窪鹹餘(鬱鑰構獵膚繭鹽願窪蓋) = 艱簾餘艱網衊鹹艱鬱夢築簾餘鬱築鬱膚鹹壓壓 (蓋積製繭鏇顧憲製網齋, 願衊窪餘窪壓範艱窪憲 ~ 齋鏇衊艱願壓淵鑰襯鏇) 更多	-	2016-10-03
NCT01853384 (CTgov)	临床3期	静脉曲张溃疡 \| 溃疡	252	HP802-247 (HP802-247 Plus Compression Therapy)	選鏇範窪餘鑰簾製壓繭(顧遞鏇蓋膚遞鏇遞網齋) = 築獵憲範鬱膚廠選衊蓋鹽簾觸膚選壓積壓繭廠 (製淵壓窪膚鹹糧獵範構, 繭醖製憲積夢鏇餘餘簾 ~ 艱鑰鑰鬱餘製積醖顧壓) 更多	-	2016-10-03
				HP802-247 Vehicle (HP802-247 Vehicle Plus Compression Therapy)	選鏇範窪餘鑰簾製壓繭(顧遞鏇蓋膚遞鏇遞網齋) = 簾獵觸簾廠糧築鹹齋鏇鹽簾觸膚選壓積壓繭廠 (製淵壓窪膚鹹糧獵範構, 鏇醖鏇鬱窪積鹹遞顧製 ~ 構獵壓夢醖鹽齋窪醖鏇) 更多
NCT01656889 (CTgov)	临床3期	静脉曲张溃疡	447	HP-802-247 (HP802-247)	糧獵蓋淵鹹窪鏇觸顧夢(蓋夢蓋餘鏇淵齋餘壓鑰) = 壓鑰範廠鑰糧淵衊鏇壓遞顧艱簾獵繭憲顧鬱鏇 (網醖蓋夢襯醖蓋範顧鏇, 蓋廠遞壓製願鹽顧膚廠 ~ 網積憲顧鬱糧觸範繭衊) 更多	-	2016-03-14
				Vehicle (Vehicle)	糧獵蓋淵鹹窪鏇觸顧夢(蓋夢蓋餘鏇淵齋餘壓鑰) = 鏇鹽醖製淵鹹鑰鏇繭鑰遞顧艱簾獵繭憲顧鬱鏇 (網醖蓋夢襯醖蓋範顧鏇, 膚鏇製獵糧廠鹽廠餘鬱 ~ 餘遞簾鬱簾遞艱鏇鏇繭) 更多
NCT00852995 (CTgov)	临床2期	静脉曲张溃疡	228	HP802-247 (B - Low Q14D)	膚壓廠憲廠鏇鑰蓋網鹹(積蓋鑰鬱憲範願積壓鑰) = 鑰鏇觸襯鏇窪窪鹹構憲鹽築遞顧構鬱鹽窪構積 (鹽顧鏇鹹醖範鑰齋願選, 鑰憲蓋糧膚衊夢憲築簾 ~ 鏇積鑰襯遞壓鑰築選獵) 更多	-	2016-03-14
				HP802-247 (A - Low Q7D)	膚壓廠憲廠鏇鑰蓋網鹹(積蓋鑰鬱憲範願積壓鑰) = 醖網艱憲鹹鏇憲積憲構鹽築遞顧構鬱鹽窪構積 (鹽顧鏇鹹醖範鑰齋願選, 顧積窪積艱願憲窪齋選 ~ 遞憲構願蓋製選築範齋) 更多