# Global clinical trial landscape of stem cell-based therapies for osteoarthritis: trends and translational implications

## TL;DR

This study maps global clinical trials of stem cell therapies for osteoarthritis, highlighting trends and challenges in translating these treatments into clinical practice.

## Contribution

The paper provides a comprehensive analysis of the global clinical trial landscape for stem cell-based osteoarthritis therapies, identifying key trends and translational barriers.

## Key findings

- The number of stem cell trials for osteoarthritis has increased globally, with a focus on knee OA and mesenchymal stem cells.
- Trials often use patient-reported outcomes, but face limitations due to design heterogeneity and short follow-up.
- Allogeneic strategies are gaining attention for their scalability, but standardization and rigorous study design remain critical needs.

## Abstract

Osteoarthritis (OA) is a leading cause of pain and disability worldwide, yet disease-modifying treatments remain limited. This study aimed to map the global registry landscape of interventional clinical trials of stem cell–based therapies for OA and summarize temporal, geographic, and design trends.

We conducted a systematic, registry-based landscape analysis of interventional clinical trials assessing stem cell therapies for osteoarthritis. Trial records were obtained from the Informa Pharmaprojects platform. Two researchers extracted and summarized trial characteristics, including year, phase, geographic distribution, target joint, cell source or type, autologous versus allogeneic strategy, administration route, outcome measures, and trial status. We then performed a descriptive trend analysis.

We identified a total of 224 eligible trials. The number of trials has steadily increased over time, with broad international participation. Most studies focused on knee osteoarthritis and used intra-articular administration. Mesenchymal stem cell-based products dominated, encompassing both autologous and allogeneic approaches, with growing attention to scalable allogeneic strategies. Primary endpoints were typically patient-reported pain and functional measures, while imaging and biomarker outcomes were often secondary. Published evidence syntheses suggest potential benefits in terms of pain and function, but conclusions are frequently limited by heterogeneity, risk of bias, and relatively short follow-up durations.

The number of stem cell–based clinical trials for osteoarthritis is increasing globally, but heterogeneity in study designs and incomplete public reporting limit reliable conclusions about efficacy. Future research should prioritize standardizing products and protocols, employing more rigorous comparators and feasible blinding, extending follow-up periods, and ensuring transparent reporting to facilitate clinical translation.