Definition and Characteristics of Mesenchymal Stromal Cells in Preclinical and Clinical Studies: A Scoping Review

Mesenchymal stromal cells (MSCs) are widely used in preclinical and clinical research. Despite minimal criteria to define MSCs provided by the International Society for Cell and Gene Therapy (ISCT), concerns have been raised about inconsistent descriptions of cell products used. To address the question How are MSCs currently defined and characterized? we conducted a scoping review on original MSC preclinical and clinical studies published over a 3-month period. Selected studies identified from a systematic search of MEDLINE and Embase were categorized as follows: Clinical, Animal, Biology, or Biomaterial studies. Data were extracted from a randomly selected subsample of studies. We extracted information, including epidemiological characteristics of studies, study design, ISCT criteria, and MSC characterization and culture condition. A total of 1053 articles were included and among them, 318 articles were analyzed. Overall, 18% of the articles explicitly referred to the ISCT minimal criteria for MSC. MSC characteristics and culture conditions were inconstantly reported (eg, viability assay reported in only 18% of the articles). Only 20% of documents reported at least 1 functional assay. Clinical studies showed inconsistent completeness in reporting relevant information on the MSC characterization and cell manufacturing processes. These results suggest that further development and implementation of a consensus definition of MSCs and reporting guidelines are needed to enhance rigor, reproducibility, and transparency in MSC research.

Automated summary

This study conducted a scoping review on original MSC preclinical and clinical studies to investigate the current definitions and characterizations of MSCs. The results showed inconsistent descriptions of MSC products and incomplete reporting of MSC characteristics and culture conditions. Only a small percentage of articles referred to the minimal criteria provided by ISCT. Clinical studies were inconsistent in reporting relevant information on MSC characterization and cell manufacturing processes. These findings suggest the need for further development and implementation of consensus definitions and reporting guidelines for MSCs to improve rigor, reproducibility, and transparency in MSC research.