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. 2024 Dec 1;110(12):7573-7584.
doi: 10.1097/JS9.0000000000002125.

Efficacy and safety of stem cell therapy for fistula management: an overview of existing systematic reviews

Tripti Tripathi  1 , Syam Mohan  2   3 , Hassan A Alfaifi  4 , Abdullah Farasani  5 , Roopashree R  6 , Pawan Sharma  7 , Abhishek Sharma  8 , Apurva Koul  9 , G V Siva Prasad  10 , Sarvesh Rustagi  11 , Jigisha Anand  12   13 , Sanjit Sah  14   15 , Shilpa Gaidhane  16 , Ganesh Bushi  17   18 , Diptismita Jena  19 , Mahalaqua N Khatib  20 , Muhammed Shabil  21   22 , Siddig I Abdelwahab  23 , Kiran Bhopte  24 , Manvi Pant  25 , Rachana Mehta  26   27 , Sakshi Pandey  28 , Manvinder Brar  29 , Nagavalli Chilakam  30 , Ashok K Balaraman  22
Affiliations

Efficacy and safety of stem cell therapy for fistula management: an overview of existing systematic reviews

Tripti Tripathi et al. Int J Surg. .

Abstract

Background: Fistulas, abnormal connections between two anatomical structures, significantly impact the quality of life and can result from a variety of causes, including congenital defects, inflammatory conditions, and surgical complications. Stem cell therapy has emerged as a promising alternative due to its potential for regenerative and immunomodulatory effects. This overview of systematic reviews aimed to assess the safety and efficacy of stem cell therapy in managing fistulas, drawing on the evidence available.

Methods: This umbrella review was conducted following the Joanna Briggs Institute (JBI) methodology to assess the efficacy and safety of stem cell therapy for treating various types of fistulas. A comprehensive search was performed across multiple electronic databases including PubMed, Embase, Cochrane Register, and Web of Science up to 5 May 2024. Systematic reviews focusing on stem cell therapy for fistulas were included, with data extracted on study design, stem cell types, administration methods, and outcomes. The quality of the reviews was assessed using the AMSTAR 2 tool, and meta-analyses were conducted using R software version 4.3.

Results: Nineteen systematic reviews were included in our umbrella review. The stem cell therapy demonstrated by significant improvements in clinical remission rates, with a relative risk (RR) of 1.299 (95% CI: 1.192-1.420). Stem cell therapy enhanced fistula closure rates, both short-term (RR=1.481; 95% CI: 1.036-2.116) and long-term (RR=1.422; 95% CI: 1.091-1.854). The safety analysis revealed no significant increase in the risk of adverse events with stem cell therapy, showing a pooled RR of 0.972 (95% CI: 0.739-1.278) for general adverse events and 1.136 (95% CI: 0.821-1.572) for serious adverse events, both of which indicate a safety profile comparable to control treatments. Re-epithelialization rates also improved (RR=1.44; 95% CI: 1.322-1.572).

Conclusion: Stem cell therapy shows promise as an effective and safe treatment for fistulas, particularly in inducing remission and promoting closure of complex fistulas. The findings advocate for further high-quality research to confirm these benefits and potentially incorporate stem cell therapy into standard clinical practice for fistula management. Future studies should focus on long-term outcomes and refining stem cell treatment protocols to optimize therapeutic efficacy.

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Conflict of interest statement

The authors declare no conflict of interest.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Figures

Figure 1
Figure 1
PRISMA flowchart depicting article selection and screening process.
Figure 2
Figure 2
Clinical remission with stem cell therapy versus control group.
Figure 3
Figure 3
Fistula closure with stem cell therapy versus control group.
Figure 4
Figure 4
Mean PDAI at 12 weeks and 24 weeks with stem cell therapy versus control group.
Figure 5
Figure 5
Re-epithelialization with stem cell therapy versus control group.
Figure 6
Figure 6
Adverse events with stem cell therapy versus control group.
Figure 7
Figure 7
Serious adverse events with stem cell therapy versus control group.
See this image and copyright information in PMC

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