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Clinical Trial
. 2025 May 21;20(5):e0324535.
doi: 10.1371/journal.pone.0324535. eCollection 2025.

Intravesical injection of peripheral blood mononuclear cell for the treatment of interstitial cystitis: A preliminary report

Ching-Pei Tsai  1   2   3   4 , Kai-Lun Cheng  5   6 , Evelyn Yang  7   8 , Lung-Yung Huang  1   2 , Fu-Hui Wang  9 , Man-Jung Hung  7   8 , Hong-Lin Su  1   2   3   10
Affiliations
Clinical Trial

Intravesical injection of peripheral blood mononuclear cell for the treatment of interstitial cystitis: A preliminary report

Ching-Pei Tsai et al. PLoS One. .

Abstract

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.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Fig 1
Fig 1. FACS Analysis of Monocytes Before and After Activation.
The FACS (Fluorescence-Activated Cell Sorting) analysis of the monocytes (CD14: monocyte marker, CD206: M2 macrophage marker) before and after activation.
Fig 2
Fig 2. Proportion of CD14
 + Monocytes Post-Purification. The proportion of CD14 + monocytes after the separation and purification process.
Fig 3
Fig 3. Cystoscopic Findings Pre- and Post-PBMC Injection.
Cystoscopic findings before and 3 months after PBMCs intravesical injection in cases 3, 4, 7 and 9.
See this image and copyright information in PMC

References

    1. Hanno PM, Landis JR, Matthews-Cook Y, Kusek J, Nyberg L Jr. The diagnosis of interstitial cystitis revisited: lessons learned from the National Institutes of Health Interstitial Cystitis Database study. J Urol. 1999;161(2):553–7. doi: 10.1016/s0022-5347(01)61948-7 - DOI - PubMed
    1. van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, et al.. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008;53(1):60–7. doi: 10.1016/j.eururo.2007.09.019 - DOI - PubMed
    1. Moldwin RM, Sant GR. Interstitial cystitis: a pathophysiology and treatment update. Clin Obstet Gynecol. 2002;45(1):259–72. doi: 10.1097/00003081-200203000-00027 - DOI - PubMed
    1. Rahnama’i MS, Javan A, Vyas N, Lovasz S, Singh N, Cervigni M, et al.. Bladder Pain Syndrome and Interstitial Cystitis Beyond Horizon: Reports from the Global Interstitial Cystitis/Bladder Pain Society (GIBS) Meeting 2019 Mumbai - India. Anesth Pain Med. 2020;10(3):e101848. doi: 10.5812/aapm.101848 - DOI - PMC - PubMed
    1. Lin C-C, Huang Y-C, Lee W-C, Chuang Y-C. New Frontiers or the Treatment of Interstitial Cystitis/Bladder Pain Syndrome - Focused on Stem Cells, Platelet-Rich Plasma, and Low-Energy Shock Wave. Int Neurourol J. 2020;24(3):211–21. doi: 10.5213/inj.2040104.052 - DOI - PMC - PubMed

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