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

被引:0
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作者
Kaufman, Melissa R. [1 ]
Goldman, Howard B. [2 ]
Chermansky, Christopher J. [3 ]
Dmochowski, Roger [4 ]
Kennelly, Michael J. [5 ]
Peters, Kenneth M. [6 ]
Quiroz, Lieschen H. [7 ]
Bennett, Jason B. [8 ]
Thomas, Sherry [9 ]
Marguet, Charles G. [10 ]
Benson, Kevin D. [11 ]
Lee, Una J. [12 ]
Sokol, Eric R. [13 ]
Wolter, Christopher E. [14 ]
Katz, Daniel M. [15 ]
Tarnay, Christopher M. [16 ]
Antosh, Danielle [17 ]
Heit, Michael H. [18 ]
Rehme, Christian [19 ]
Karram, Mickey [20 ]
Snyder, Scott [21 ]
Canestrari, Emanuele [22 ]
Jankowski, Ron J. [22 ]
Chancellor, Michael B. [6 ]
机构
[1] Vanderbilt Univ, Med Ctr, Nashville, TN 37235 USA
[2] Cleveland Clin, Lerner Coll Med, Cleveland, OH USA
[3] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA
[4] Vanderbilt Univ, Med Ctr, Pittsburgh, PA USA
[5] Atrium Hlth, Carolinas Med Ctr, Charlotte, NC USA
[6] Oakland Univ, Corewell Hlth Syst, William Beaumont Sch Med, Rochester, MN USA
[7] Univ Oklahoma, Hlth Sci Ctr, Oklahoma City, OK USA
[8] Mercy Hlth St Marys Campus, Grand Rapids, MI USA
[9] Univ Southern Calif, Keck Sch Med, Los Angeles, CA USA
[10] Prisma Hlth Reg Urol, Greenville, SC USA
[11] Univ South Dakota, Sanford Sch Med, Sch Med, Sioux Falls, SD USA
[12] Virginia Mason Franciscan Hlth, Seattle, WA USA
[13] Stanford Univ, Sch Med, Stanford, CA USA
[14] Mayo Clin Arizona, Phoenix, AZ USA
[15] Premier Med Grp Hudson Valley, Poughkeepsie, NY USA
[16] UCLA, David Geffen Sch Med, Los Angeles, CA USA
[17] Houston Methodist Hosp, Houston, TX USA
[18] Emory Univ, Sch Med, Atlanta, GA USA
[19] Univ Klinikum Essen, Essen, Germany
[20] Christ Hosp, Cincinnati, OH USA
[21] Cook Regentec LLC, 1102 Indiana Ave, West Layfette, IN 46202 USA
[22] Cook MyoSite Inc, Pittsburgh, PA USA
关键词
autologous myoblasts; cell therapy; regenerative medicine; skeletal muscle cells; stress urinary incontinence; SURGICAL-TREATMENT; GUIDELINES; COMMUNITY; QUALITY; WOMEN; LIFE;
D O I
10.1002/nau.25588
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Aims: This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI). Methods: Adult females were randomized 2:1 to iltamiocel (150 x 106 6 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 - 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. Results: The study enrolled 311 patients, 297 were randomized to either iltamiocel (n n = 199) or placebo (n n = 98). Of the 295 participants that completed 12 months blinded follow-up, - 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. Conclusion: The 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.
引用
收藏
页码:2290 / 2299
页数:10
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