Dutta Rahul, Yoo James J, Atala Anthony, Day Mary-Clare, Evans Robert, Langefeld Carl D, Mirzazadeh Majid, Badlani Gopal
Department of Urology, Wake Forest University School of Medicine, Winston Salem, NC 27101, United States.
Department of Urology, University of California Los Angeles David Geffen School of Medicine, Los Angeles, CA 90095, United States.
Stem Cells Transl Med. 2025 Oct 11;14(10). doi: 10.1093/stcltm/szaf039.
The transplantation of autologous muscle precursor cells (MPCs) is effective in the regeneration of muscle in multiple pathologies. This phase I clinical trial sought to use MPCs to treat stress urinary incontinence (UI).
Female patients with either stress urinary incontinence (SUI) or congenitally acquired UI had thigh muscle biopsies prior to MPC expansion and processing. The MPCs were injected directly into the bladder neck. Symptoms were measured using pad weight tests (1-h and 3-day), baseline questionnaires (Urogenital Distress Inventory [UDI-6], Incontinence Impact Questionnaire [IIQ-7]), and self-reported accident frequencies.
Ten women aged 16-75 were included. For the 8 SUI subjects, there was a reduction in pad weight between pre- and post-treatment for the 1-h (P < .0001) and 3-day (P = .0076) pad tests after adjusting for age, gravida, and body mass index. The reduction was observed by the 6-week post-treatment visit and remained relatively constant thereafter. There was no evidence of a difference among the 4 post-treatment pad weights for either the 1-h (P > .05) or the 3-day (P > .05) pad tests. Similarly, there was evidence of a reduction from pre- to post-treatment in UDI-6 (P = .0034), IIQ-7 (P = .0455), and the number of self-reported accidents (P = .0656). There was no evidence of regression during the post-treatment visits for UDI-6 (P > .5), IIQ-7 (P > .25), and the number of self-reported accidents (P > .25). The 2 subjects with congenital incontinence did not improve (P > .05).
Autologous thigh muscle-derived MPC injection into the bladder neck is a safe and well-tolerated treatment for acquired stress UI in adult women.
自体肌肉前体细胞（MPCs）移植在多种病理状态下的肌肉再生中有效。这项I期临床试验旨在使用MPCs治疗压力性尿失禁（UI）。
患有压力性尿失禁（SUI）或先天性获得性尿失禁的女性患者在MPCs扩增和处理前进行大腿肌肉活检。将MPCs直接注射到膀胱颈。使用护垫重量测试（1小时和3天）、基线问卷（泌尿生殖系统困扰量表[UDI - 6]、尿失禁影响问卷[IIQ - 7]）和自我报告的意外发生频率来测量症状。
纳入了10名年龄在16 - 75岁的女性。对于8名SUI受试者，在调整年龄、妊娠次数和体重指数后，1小时（P <.0001）和3天（P =.0076）护垫测试的治疗前后护垫重量有所减轻。在治疗后6周的随访中观察到这种减轻，此后保持相对稳定。对于1小时（P >.05）或3天（P >.05）护垫测试，4个治疗后护垫重量之间没有差异的证据。同样，有证据表明UDI - 6（P =.0034）、IIQ - 7（P =.0455）和自我报告的意外发生次数（P =.0656）从治疗前到治疗后有所减少。在UDI - 6（P >.5）、IIQ - 7（P >.25）和自我报告的意外发生次数（P >.25）的治疗后随访中没有复发的证据。2名先天性尿失禁受试者没有改善（P >.05）。
将自体大腿肌肉来源的MPCs注射到膀胱颈是成年女性获得性压力性尿失禁的一种安全且耐受性良好的治疗方法。
