Assessing the landscape of clinical and observational trials involving bioprinting: a scoping review.

Abstract

Objective: Bioprinting is a tissue engineering technique that is rapidly evolving to include complex clinical applications. However, there is limited evidence describing how far bioprinting has progressed past the pre-clinical stage. Thus, we conducted a scoping review to assess the landscape of clinical studies, including interventional and observational trials, involving bioprinting by charting trends in general characteristics, bioprinting application, and trial design.

Methods: The term "bioprint" and its variants were searched in five trial databases (ICTRP, ScanMedicine, CENTRAL, NIHCC, HCCTD) and two registries (ClinicalTrials.gov, PHRR) on 22 February 2024. This was followed by duplicate removal and dual independent review to finalize the inclusion list. We included trials published in or translated to English mentioning "bioprint" in their design, while we excluded those that did not adhere to our definition of bioprinting. Finally, data were charted and synthesized narratively.

Results: Of 36 total search records, 11 trials met the inclusion criteria. Registration dates ranged from 2016 to 2023, with China conducting the most trials globally. Four trials had published results, while the remaining were still in progress. Four interventional trials aimed to implant bioprinted tissues made with autologous cells, including blood vessels, trachea, external ear, and wound dressings. The other seven studies were interventional and observational trials aiming to bioprint autologous cell-laden in vitro models to study conditions such as cancer.

Conclusion: Bioprinting is still in the early stages of clinical research, with a focus on producing patient-specific tissues for cancer precision medicine and regenerative purposes. More standardized reporting of bioprinting-related information is needed to improve research transparency and replicability. As the body of evidence grows, our review may be used as a framework to monitor the clinical translation of bioprinting over the years.