drugset / Trial / NCT01893138
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Timeline
- Start
- 2013-11-21
- Primary completion
- 2019-11-01
- Completion
- 2020-11-10
Outcome
Missed primary endpoint
paper The study did not meet its primary endpoint however PMID 39282854 ↗
paper the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). PMID 39282854 ↗
Publications
- Kaufman MR, Goldman HB, Chermansky CJ, Dmochowski R, Kennelly MJ, Peters KM, Quiroz LH, Bennett JB, Thomas S, Marguet CG, Benson KD, Lee UJ, Sokol ER, Wolter CE, Katz DM, Tarnay CM, Antosh D, Heit MH, Rehme C, Karram M, Snyder S, Canestrari E, Jankowski RJ, Chancellor MB. Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial. Neurourol Urodyn. 2024 Nov;43(8):2290-2299. doi: 10.1002/nau.25588. Epub 2024 Sep 16.
- Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iltamiocel | Cell therapy | 1.5e+08 cells | Other |