Tsai Ching-Pei, Cheng Kai-Lun, Yang Evelyn, Huang Lung-Yung, Wang Fu-Hui, Hung Man-Jung, Su Hong-Lin
Department of Life Sciences, National Chung Hsing University, Taichung, Taiwan.
Doctoral Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan.
PLoS One. 2025 May 21;20(5):e0324535. doi: 10.1371/journal.pone.0324535. eCollection 2025.
Interstitial cystitis (IC) is a complex syndrome characterized by symptoms such as bladder pain, urgency, frequency, and nocturia, without the presence of urinary tract infection or any other identifiable pathology. Traditional treatments, including medication and bladder instillation, are often ineffective in about 30% of patients. Currently, efforts are focused on developing therapies based on the possible pathogenesis of IC. This study is a phase one clinical trial which aimed to investigate the safety and efficacy of autologous peripheral blood mononuclear cell (PBMC) intravesical injections, which have the potential to promote tissue regeneration, as a novel treatment for IC. The study involved isolating PBMCs using the Sepax Cell Separation System and injecting these cells beneath the bladder mucosa layer of patients with IC. Clinical efficacy was evaluated using voiding diaries, questionnaires, and cystoscopic examinations before and 3 months after treatment. Twelve patients with refractory IC participated in this study. Observed side effects, such as pain or urinary tract infection, were mild and transient which demonstrated the safety of this treatment modality. Although the treatment response varied among patients, a third of the patients experienced moderate to significant progress according to the GRA score. Four patients exhibited improvement in bladder glomerulations during postoperative follow-up cystoscopy. In conclusion, the overall safety profile of PBMCs injections appears to be favorable. Further research is needed to optimize treatment protocols and understand the factors influencing individual responses to this therapy.
间质性膀胱炎（IC）是一种复杂的综合征，其特征为膀胱疼痛、尿急、尿频和夜尿等症状，且不存在尿路感染或任何其他可识别的病理状况。包括药物治疗和膀胱灌注在内的传统治疗方法，在约30%的患者中往往无效。目前，研究重点在于根据IC可能的发病机制开发治疗方法。本研究是一项一期临床试验，旨在调查自体外周血单个核细胞（PBMC）膀胱内注射作为IC的一种新治疗方法的安全性和有效性，这种注射有促进组织再生的潜力。该研究包括使用Sepax细胞分离系统分离PBMC，并将这些细胞注射到IC患者的膀胱黏膜下层。使用排尿日记、问卷以及治疗前和治疗后3个月的膀胱镜检查来评估临床疗效。12名难治性IC患者参与了本研究。观察到的副作用，如疼痛或尿路感染，轻微且短暂，证明了这种治疗方式的安全性。尽管患者的治疗反应各不相同，但根据GRA评分，三分之一的患者有中度至显著改善。4名患者在术后随访膀胱镜检查时膀胱滤泡有改善。总之，PBMC注射的总体安全性似乎良好。需要进一步研究以优化治疗方案，并了解影响个体对该治疗反应的因素。
