Iltamiocel (Cook MyoSite)(Iltamiocel (Cook MyoSite)) - 在研适应症：大便失禁，压力性尿失禁，吞咽障碍_专利_临床

概要

基本信息

药物类型

干细胞疗法

别名

AMDC - Cook MyoSite、AMDC-USR、Autologous muscle derived cells - Cook MyoSite

+ [1]

靶点-

作用机制

细胞替代物

治疗领域

消化系统疾病泌尿生殖系统疾病肿瘤+ [2]

在研适应症

大便失禁压力性尿失禁吞咽障碍+ [1]

非在研适应症-

原研机构

Cook MyoSite, Inc.

在研机构

Cook MyoSite, Inc.

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

11

项与 Iltamiocel (Cook MyoSite) 相关的临床试验

NCT03997318 / Withdrawn临床3期

JPN1: A Confirmatory, Bridging, Double-Blind, Randomized, Controlled Trial in Japan Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

This is a confirmatory/bridging study to evaluate the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo in the treatment of stress urinary incontinence (SUI) in adult Japanese female subjects. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

开始日期2025-06-01

申办/合作机构

Cook MyoSite, Inc.

NCT05776277 / Recruiting临床3期

A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Participants With Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

开始日期2024-03-21

申办/合作机构

Cook MyoSite, Inc.

NCT05421689 / Recruiting临床1/2期IIT

A Multi-Center, Double-Blind, Randomized Placebo-Controlled Investigation of Autologous Muscle Derived Cells (AMDC) for the Treatment of Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer

The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

开始日期2022-05-26

申办/合作机构

University of California, Davis

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100 项与 Iltamiocel (Cook MyoSite) 相关的临床结果

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100 项与 Iltamiocel (Cook MyoSite) 相关的转化医学

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100 项与 Iltamiocel (Cook MyoSite) 相关的专利（医药）

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3

项与 Iltamiocel (Cook MyoSite) 相关的文献（医药）

2024-11-01·Neurourology and Urodynamics

Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double‐Blind, Randomized, Stratified, Placebo‐Controlled Trial

Article

作者: Antosh, Danielle ; Peters, Kenneth M. ; Marguet, Charles G. ; Lee, Una J. ; Tarnay, Christopher M. ; Kaufman, Melissa R. ; Snyder, Scott ; Heit, Michael H. ; Goldman, Howard B. ; Dmochowski, Roger ; Benson, Kevin D. ; Rehme, Christian ; Sokol, Eric R. ; Kennelly, Michael J. ; Quiroz, Lieschen H. ; Canestrari, Emanuele ; Chancellor, Michael B. ; Wolter, Christopher E. ; Jankowski, Ron J. ; Katz, Daniel M. ; Karram, Mickey ; Chermansky, Christopher J. ; Bennett, Jason B. ; Thomas, Sherry

ABSTRACTAimsThis study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI).MethodsAdult females were randomized 2:1 to iltamiocel (150 × 106 cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3‐day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open‐label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations.ResultsThe study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow‐up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants.ConclusionThe study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted.Trial RegistrationClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014‐002919‐41.

2020-09-01·World Journal of Urology2区 · 医学

Contemporary application of autologous muscle-derived cells for urinary sphincter regeneration

2区 · 医学

Review

作者: Kaufman, Melissa R

OBJECTIVEStress urinary incontinence (SUI) remains a prevalent condition with substantial economic and quality-of-life impact. Treatment for incontinence historically culminates with invasive surgical procedures with recognized complication profiles. Innovative directions for SUI therapeutics are on the horizon, including the utilization of adult autologous muscle-derived cells for urinary sphincter regeneration (AMDC-USR). Herein, we visit fundamental concepts of innovative regenerative medicine technologies for urologic applications.METHODSSynopsis of contemporary literature review regarding adult autologous muscle-derived cells for urinary sphincter regeneration is presented.RESULTSCurrent published literature presents safety and efficacy data regarding AMDC-USR injection in 80 patients at 12-month follow-up. In these early studies, no long-term adverse events were reported and patients undergoing cellular injection at higher doses revealed at least 50% reduction in stress leaks and pad weight at 12-month follow-up. All dose groups demonstrated statistically significant improvement in patient-reported incontinence-specific quality-of-life scores at 12-month follow-up. Conclusions from the pooled analyses indicate that injection of AMDC-USR across a range of dosages appears safe. Efficacy data suggest a dose response with more patients responsive to the higher doses of AMDC-USR.CONCLUSIONApplications for utilization of autologous cellular therapies for treatment of SUI, and conceivably multiple additional indications, are approaching realization. Multiple Phase III randomized, placebo-controlled studies for AMDC-USR are concluding or ongoing to launch this regenerative option for the millions of patients who may ultimately benefit.

Annals of Surgery

Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study

Article

作者: Knowles, Charles ; Canestrari, Emanuele ; Raval, Manoj J. ; Cardello, Kelly ; Jankowski, Ron

Objective:To examine the safety and efficacy of iltamiocel, an investigational cellular therapy of autologous muscle-derived cells, as a treatment for fecal incontinence (FI) in adults.Background:Limited therapeutic options are available for patients with FI refractory to conservative treatments. Cell therapy using autologous muscle-derived cells represents a promising, minimally invasive approach for restoring anal sphincter function.Methods:In this multicenter, prospective, non-randomized study, 48 participants were treated with a single iltamiocel dose of 250×106 cells. The primary outcome was the incidence of product or procedure-related adverse events (AEs) and serious adverse events (SAEs). Secondary outcomes were changes in number of FI episodes, Cleveland Clinic Incontinence Score (CCIS), Fecal Incontinence Quality of Life (FIQL), and anorectal manometry at 3, 6, and 12 months compared to baseline.Results:No SAEs and only one product-related AE of inflammation at the injection site were reported. At 12 months, there was a reduction in median FI episodes (-6.0; 95% CI: −10.0, −1.0) and days with episodes (−4.0; 95% CI: −8.0, −1.0). A ≥50% reduction in FI episodes was observed in 53.7% of participants, and 24.4% had complete restoration of continence. Symptom severity and quality of life improved with mean CCIS reduction (-2.9; 95% CI: - 3.7, −2.1), and FIQL increased (2.2; 95% CI:1.4, 2.9). No significant changes were detected in anorectal manometry measurements. A history of episiotomy was significantly associated with treatment response in multivariate analysis.Conclusion:The administration of iltamiocel cellular therapy is safe. Iltamiocel shows promise for significantly improving fecal incontinence symptoms and quality of life.

100 项与 Iltamiocel (Cook MyoSite) 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
大便失禁	临床3期	美国	Cook MyoSite, Inc.	2024-03-21
压力性尿失禁	临床3期	英国	Cook MyoSite, Inc.	2011-11-04
吞咽障碍	临床2期	美国	Cook MyoSite, Inc.	2022-05-26
头颈部肿瘤	临床2期	美国	Cook MyoSite, Inc.	2022-05-26
压力性尿失禁	临床2期	加拿大	Cook MyoSite, Inc.	2011-11-04
压力性尿失禁	临床前	德国	Cook MyoSite, Inc.	2011-11-04
压力性尿失禁	临床前	加拿大	Cook MyoSite, Inc.	2011-11-04
压力性尿失禁	临床前	德国	Cook MyoSite, Inc.	2011-11-04

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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


NCT01893138 (Pubmed \| Neurourol Urodyn) 人工标引	临床3期	压力性尿失禁	297	Iltamiocel	(鑰選蓋顧觸鬱構觸餘鹹) = 蓋鹽鹹餘簾簾製艱鹹鏇醖膚願製糧壓廠遞築衊 (憲繭衊醖鹽廠夢鏇餘觸 ) 未达到更多	不佳	2024-09-16
NCT01893138 (Pubmed \| Neurourol Urodyn) 人工标引	临床3期	压力性尿失禁	297	Placebo	(鑰選蓋顧觸鬱構觸餘鹹) = 淵鏇築醖淵壓獵範壓襯醖膚願製糧壓廠遞築衊 (憲繭衊醖鹽廠夢鏇餘觸 ) 未达到更多	不佳	2024-09-16
NCT01600755 (CTgov)	临床1/2期	大便失禁	53	Iltamiocel	夢糧膚顧獵廠構餘製鏇(鏇窪衊壓廠簾鹹範遞築) = 廠餘願顧網糧繭憲築糧憲廠選艱糧獵繭糧窪窪 (範衊範築憲鏇衊鏇憲鑰, 膚範憲醖製蓋廠餘鬱顧 ~ 膚遞遞齋積衊繭構積衊) 更多	-	2024-02-16
NCT01893138 (2014-002919-41, CTgov)	临床3期	压力性尿失禁	311	Iltamiocel (Iltamiocel)	膚範齋積網壓網鹽積鹽(遞餘網觸蓋觸醖製觸積) = 膚夢蓋艱蓋淵鬱鏇願鬱繭憲餘齋願觸願鹹壓鏇 (衊壓製窪顧醖糧廠顧遞, 夢選遞鑰餘顧觸憲網憲 ~ 窪餘醖壓遞醖積糧積蓋) 更多	-	2023-01-05
NCT01893138 (2014-002919-41, CTgov)	临床3期	压力性尿失禁	311	Placebo (Placebo)	膚範齋積網壓網鹽積鹽(遞餘網觸蓋觸醖製觸積) = 壓鹽鹽鏇鬱糧遞鑰願襯繭憲餘齋願觸願鹹壓鏇 (衊壓製窪顧醖糧廠顧遞, 選鑰窪構觸鏇餘憲網窪 ~ 鹹窪選壓顧艱餘構選壓) 更多	-	2023-01-05
NCT02291432 (CTgov)	临床1/2期	压力性尿失禁 \| 泌尿系统表现 \| 下尿路症状	25	autologous muscle-derived cells (AMDC)	鑰製繭鏇壓憲願醖餘構(顧鏇鏇餘鬱餘觸鏇築顧) = 繭簾窪齋範築齋遞網齋獵繭鏇遞夢鏇廠獵醖鹽 (繭壓觸壓襯夢窪選鏇簾, 網獵積艱膚鑰願廠夢鑰 ~ 顧簾範構壓鏇願構糧選) 更多	-	2021-10-26
NCT01382602 (CTgov)	临床3期	压力性尿失禁	150	AMDC-USR (AMDC-USR)	選鹽夢膚夢製齋襯廠簾(憲網鬱醖憲鏇廠繭夢憲) = 築範齋壓範觸窪衊廠觸選鏇蓋窪鏇範選淵鹽衊 (淵網艱糧積齋襯蓋夢蓋, 夢範選壓憲窪願醖蓋築 ~ 廠廠淵艱壓觸繭製簾糧) 更多	-	2018-05-17
NCT01382602 (CTgov)	临床3期	压力性尿失禁	150	Placebo (Placebo)	選鹽夢膚夢製齋襯廠簾(憲網鬱醖憲鏇廠繭夢憲) = 觸鑰鬱獵鑰獵鹽窪繭網選鏇蓋窪鏇範選淵鹽衊 (淵網艱糧積齋襯蓋夢蓋, 繭選淵餘窪齋願餘夢構 ~ 憲淵網繭製壓衊網鏇鏇) 更多	-	2018-05-17
NCT01008943 (CTgov)	临床2期	压力性尿失禁	16	Autologous Muscle-Derived Cells (AMDC)	窪鏇糧鬱餘餘餘簾襯積(壓夢觸鬱遞廠製網鹹夢) = 鹹鏇願鏇觸鹹鏇襯構壓齋膚廠製壓齋淵壓築積 (廠選憲鏇齋願鏇醖鹹築, 糧壓壓艱襯構憲夢憲艱 ~ 廠獵鬱構醖選淵鏇鏇積) 更多	-	2015-11-03