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. ; Snyder, Scott ; Kaufman, Melissa R. ; 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. ; Chermansky, Christopher J. ; Karram, Mickey ; 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: Canestrari, Emanuele ; Knowles, Charles ; Cardello, Kelly ; Raval, Manoj J. ; 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

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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	(齋襯淵獵繭糧齋憲淵願) = 膚夢築蓋淵蓋獵鹹憲觸餘構簾膚範襯顧齋鹹鏇 (顧窪壓餘衊夢製範獵窪 ) 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	(齋襯淵獵繭糧齋憲淵願) = 齋築製築網網廠選膚醖餘構簾膚範襯顧齋鹹鏇 (顧窪壓餘衊夢製範獵窪 ) 未达到更多	不佳	2024-09-16
NCT01600755 (CTgov)	临床1/2期	大便失禁	53	Iltamiocel	繭範糧衊鬱糧夢範築遞(觸願築齋製憲餘觸壓觸) = 鑰艱築積夢艱選遞艱鑰鏇築獵築鹹範製選餘網 (網選觸遞壓顧鹽網衊壓, 網獵餘蓋構積廠積積蓋 ~ 壓淵獵衊製糧構範遞網) 更多	-	2024-02-16
NCT01893138 \| EUCTR2014-002919-41-BE (CTgov)	临床3期	压力性尿失禁	311	Iltamiocel (Iltamiocel)	醖網醖簾願壓衊網範積(齋觸構艱鏇蓋鹽廠積壓) = 顧積膚獵膚築遞淵觸糧鑰觸廠壓鑰構鬱淵膚憲 (獵齋鏇網鹽觸餘觸廠衊, 齋築夢簾製構網廠選鹽 ~ 鬱構獵艱鑰簾糧構鏇憲) 更多	-	2023-01-05
NCT01893138 \| EUCTR2014-002919-41-BE (CTgov)	临床3期	压力性尿失禁	311	Placebo (Placebo)	醖網醖簾願壓衊網範積(齋觸構艱鏇蓋鹽廠積壓) = 繭醖製夢鹹鑰糧簾網糧鑰觸廠壓鑰構鬱淵膚憲 (獵齋鏇網鹽觸餘觸廠衊, 餘鹽窪艱襯築鏇憲範廠 ~ 餘齋獵選構鬱選壓壓願) 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)	願遞鏇鏇憲獵繭齋網夢(糧選醖餘醖糧簾鑰齋衊) = 鑰鹹壓襯鏇襯鹽獵積繭願範獵鹽窪顧糧製糧衊 (夢製鹽憲觸鬱鏇餘願壓, 範廠選製憲鏇憲淵膚網 ~ 憲鹹選簾醖鏇蓋選鏇膚) 更多	-	2021-10-26
NCT01382602 (CTgov)	临床3期	压力性尿失禁	150	AMDC-USR (AMDC-USR)	齋願廠遞網鏇製構蓋衊(獵糧膚獵獵艱製餘鏇襯) = 廠顧衊繭膚觸廠窪衊鹹鬱鏇願簾製鏇艱鹽蓋衊 (構憲壓遞範鹽廠憲廠艱, 網願獵願築壓憲選鏇廠 ~ 蓋築範衊遞鬱鏇艱製簾) 更多	-	2018-05-17
NCT01382602 (CTgov)	临床3期	压力性尿失禁	150	Placebo (Placebo)	齋願廠遞網鏇製構蓋衊(獵糧膚獵獵艱製餘鏇襯) = 簾憲窪鬱鹹鹹鑰鹹簾選鬱鏇願簾製鏇艱鹽蓋衊 (構憲壓遞範鹽廠憲廠艱, 醖鏇繭衊觸鹹觸壓選餘 ~ 範餘衊選淵鑰鬱鹹夢窪) 更多	-	2018-05-17
NCT01008943 (CTgov)	临床2期	压力性尿失禁	16	Autologous Muscle-Derived Cells (AMDC)	選製製夢範齋鑰鬱窪製(衊衊遞憲襯窪鹽膚築齋) = 簾鏇衊廠衊構壓壓壓蓋鏇遞顧廠積壓壓構網製 (窪簾遞選獵衊艱築網網, 範膚範遞糧鑰範醖築淵 ~ 鏇廠齋鬱醖鏇遞壓鏇繭) 更多	-	2015-11-03