Improvement of Neurogenic Bladder Dysfunction Following Combined Cell Therapy with Mesenchymal Stem Cell and Schwann Cell in Spinal Cord Injury: A Randomized, Open-Label, Phase II Clinical Trial.

Abstract

To investigate the efficacy of intrathecal combined administration of autologous bone marrow-derived mesenchymal stem cells (BMSCs) and Schwann cells (SCs) in urinary function improvement in complete spinal cord injury (SCI) patients for the first time. This study was a randomized phase II clinical trial, including treatment and control arms. Patients with traumatic complete SCI-induced neurogenic bladder were included. The treatment group received a single intrathecal combined injection of autologous BMSCs and SCs. The control group underwent no additional intervention. The outcome measures of the study were urodynamic study parameters, number of incontinence and urinary tract infection episodes, incontinence quality of life questionnaire, functional status, and sensorimotor improvements. Among a total of 32 recruited patients, 13 and 16 were completely followed up in the treatment and control group, respectively. Changes in bladder compliance (P = 0.032), maximum pressure of detrusor during the filling phase (P = 0.013), maximum pressure of detrusor at the maximum urinary flow rate (P = 0.020), maximum urinary flow rate (P = 0.001), and postvoid residual volume (P = 0.001) after 6 months were significantly different between the 2 groups. The number of urinary incontinence episodes (P = 0.022) significantly reduced in the treatment group after 6 months compared with the baseline. The incontinence quality of life total and domain scores significantly improved in the treatment group compared with the control group after 6 months. The combined intrathecal administration of BMSCs and SCs significantly improved the urodynamic study parameters, urinary incontinence rate, and incontinence quality of life in complete SCI-induced neurogenic bladder.