Mapping the landscape and future directions of stem cell therapy for inflammatory bowel disease

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

This study systematically analyzed 170 registered clinical trials to clarify the global development landscape of stem cell therapy for inflammatory bowel disease (IBD) and its core challenges, and put forward corresponding future research directions. The results showed that the research on this therapy has accelerated significantly in the past three decades, with research geographically clustered in the US, China and Spain, and severe underrepresentation of African countries. The therapy is mainly focused on Crohn's disease (CD), especially refractory perianal fistulas, and mesenchymal stem cells (MSCs) account for over 70% of the applied cell types. Among 88 completed trials, 29.5% achieved primary endpoints, showing preliminary efficacy, yet the field faces prominent challenges: 20.6% of trials were prematurely terminated, early-phase studies dominate, Phase IV trials and long-term efficacy data are scarce, primary endpoints are highly heterogeneous, pediatric research is limited, and most completed trials have unknown outcomes. To address these issues, this study proposes that the future research should prioritize international cooperation to promote research equity, standardize efficacy endpoints, integrate long-term follow-up into study designs, optimize stem cell source and administration protocols, and implement precise patient selection. Overcoming these bottlenecks is

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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