Clinical trial landscape for stem cells in autoimmune and inflammatory diseases: a comprehensive analysis and path forward.

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

• 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)

Background Autoimmune and inflammatory diseases present significant therapeutic challenges due to their chronic nature and limited response to conventional treatments. Stem cell-based therapies have emerged as a promising approach, leveraging their immunomodulatory and regenerative properties to address treatment-resistant cases. Methods We conducted a comprehensive analysis of 1136 stem cell clinical trials from the TrialTrove database (October 2024), focusing on therapeutic efficacy, trial progression patterns, and geographic distribution. Key clinical outcomes and safety profiles were systematically evaluated. A choropleth map (Figure 1C) summarizes national activity across continents, with darker shading indicating more trials. Results Stem cell trials showed substantial growth over two decades, increasing from 11 trials annually (2000-2004) to a peak of 73 trials in 2019. However, translation to late-phase studies remains limited, with only 10.2% of trials advancing to Phase III. Notable therapeutic successes include a 92.5% survival rate in systemic lupus erythematosus using umbilical cord mesenchymal stem cells and a 56.3% remission rate in Crohn's disease with adipose-derived mesenchymal stem cells versus 38.6% with placebo ( P = 0.010). Safety analyses across 36 randomized controlled trials involving 2076 participants demonstrated favorable safety profiles. These dynam

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

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