Efficacy of Stem Cell Therapy for Interstitial Cystitis/Bladder Pain Syndrome: A Systematic Review and Meta‐Analysis of Preclinical Studies
Tao Yang, Wu Tang, Yuanzhi Li, Junchao Wu, Huitao Wang, Xiang Zhao, Kewei FangBackground
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a refractory urological disorder for which effective disease‐modifying treatments remain limited. This meta‐analysis evaluates the preclinical efficacy of stem cell interventions for IC/BPS and establishes an evidence‐based roadmap for clinical translation.
Methods
A systematic search of PubMed, Embase, Web of Science, and Cochrane Library was performed (up to July 8, 2025). Risk of bias was appraised using the SYRCLE framework. Our outcomes focused on bladder histopathology, local inflammatory markers, urodynamic profiles, voiding patterns, and nociceptive behaviors.
Results
Eighteen studies (27 comparisons) evaluating interventions based on mesenchymal stem/stromal cells (MSCs) in rat models were included. Stem cell therapy significantly alleviated histopathological damage by reducing mast cell infiltration (SMD = −2.42), collagen deposition (SMD = −2.13), and apoptosis (SMD = −3.09), while suppressing proinflammatory cytokines (TNF‐α, IL‐6, IL‐1β). Functionally, interventions increased bladder capacity (SMD = 2.69), prolonged intercontraction intervals (SMD = 2.39), and markedly alleviated visceral pain (SMD = −3.19). Subgroup analyses identified human embryonic stem cell (hESC)‐derived multipotent mesenchymal stem cells (M‐MSCs) as the most extensively validated reference type, though other cell types exhibited phenotype‐specific potential. Furthermore, a dose of 1 × 10 6 cells/rat, localized bladder wall injection (BWI), and allogeneic sources were identified as the most favorable preclinical parameters among the evaluated studies.
Conclusions
Stem cell therapy—predominantly represented by MSCs—represents a promising candidate intervention with potential disease‐modifying properties for IC/BPS in preclinical models. To inform future trial designs, we suggest a preliminary, theoretically scaled human equivalent dose window of 2.0 × 10 7 to 5.0 × 10 7 cells, preferentially administered via localized BWI. By exploring optimal cellular parameters and translational barriers, this study provides an evidence‐based reference framework to guide the transition of stem cell therapy from bench to bedside.