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Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial.
Kaufman, Melissa R; Goldman, Howard B; Chermansky, Christopher J; Dmochowski, Roger; Kennelly, Michael J; Peters, Kenneth M; Quiroz, Lieschen H; Bennett, Jason B; Thomas, Sherry; Marguet, Charles G; Benson, Kevin D; Lee, Una J; Sokol, Eric R; Wolter, Christopher E; Katz, Daniel M; Tarnay, Christopher M; Antosh, Danielle; Heit, Michael H; Rehme, Christian; Karram, Mickey; Snyder, Scott; Canestrari, Emanuele; Jankowski, Ron J; Chancellor, Michael B.
Afiliación
  • Kaufman MR; Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Goldman HB; Lerner College of Medicine Cleveland Clinic, Cleveland, Ohio, USA.
  • Chermansky CJ; University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
  • Dmochowski R; Vanderbilt University Medical Center, Pittsburgh, Pennsylvania, USA.
  • Kennelly MJ; Atrium Health, Carolinas Medical Center, Charlotte, North Carolina, USA.
  • Peters KM; Corewell Health System, Oakland University William Beaumont School of Medicine, Rochester, Minnesota, USA.
  • Quiroz LH; University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
  • Bennett JB; Mercy Health Saint Mary's Campus, Grand Rapids, Michigan, USA.
  • Thomas S; Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
  • Marguet CG; Prisma Health Regional Urology, Greenville, South Carolina, USA.
  • Benson KD; Sanford Health/University of South Dakota School of Medicine, Sioux Falls, South Dakota, USA.
  • Lee UJ; Virginia Mason Franciscan Health, Seattle, Washington, USA.
  • Sokol ER; Stanford University School of Medicine, Stanford, California, USA.
  • Wolter CE; Mayo Clinic Arizona, Phoenix, Arizona, USA.
  • Katz DM; Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, USA.
  • Tarnay CM; David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
  • Antosh D; Houston Methodist Hospital, Houston, Texas, USA.
  • Heit MH; Emory University School of Medicine, Atlanta, Georgia, USA.
  • Rehme C; Universitätsklinikum Essen, Essen, Germany.
  • Karram M; Christ Hospital, Cincinnati, Ohio, USA.
  • Snyder S; Cook Research Incorporated, West Layfette, Indiana, USA.
  • Canestrari E; Cook MyoSite Incorporated, Pittsburgh, Pennsylvania, USA.
  • Jankowski RJ; Cook MyoSite Incorporated, Pittsburgh, Pennsylvania, USA.
  • Chancellor MB; Corewell Health System, Oakland University William Beaumont School of Medicine, Rochester, Minnesota, USA.
Neurourol Urodyn ; 43(8): 2290-2299, 2024 Nov.
Article en En | MEDLINE | ID: mdl-39282854
ABSTRACT

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 21 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.

RESULTS:

The 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.

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. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT01893138; EudraCT number 2014-002919-41.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante Autólogo / Incontinencia Urinaria de Esfuerzo Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Neurourol Urodyn Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trasplante Autólogo / Incontinencia Urinaria de Esfuerzo Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Neurourol Urodyn Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos