The Global Landscape of Stem Cell Clinical Trials

Abstract

Aim: To provide a comprehensive analysis of clinical trials (CTs) listed in worldwide registries involving new applications for stem cell-based treatments and account for the role of industry. Materials & methods: We developed a data set of 4749 stem cell CTs up to 2013 in worldwide registries. We defined 1058 novel CTs (i.e., trials that were not observational in nature; did not involve an established stem cell therapy for an established indication, such as hematopoietic stem cells for leukemia; and did not investigate supportive measures). Based on trial descriptions, we manually coded these for eight additional elements. Results: Our analysis details the characteristics of novel stem cell CTs (e.g., stem cell types being tested, disease being targeted, and whether interventions were autologous or allogeneic), geotemporal trends, and private sector involvement as sponsor or collaborator. Conclusion: The field is progressing at a steady pace with emerging business models for stem cell therapeutics. However, therapeutic rhetoric must be tempered to reflect current clinical and research realities.

KEYWORDS::

• business model
• cardiac
• clinical translation
• clinical trial
• hematopoietic stem cell
• industry
• mesenchymal stem cell
• neurological
• stem cell mobilization
• stem cell therapy

supplementary Material

Author contributions

T Bubela and H Atkins designed the research questions; MD Li and H Atkins developed the final clinical trial coding frame and completed the data analysis; and MD Li, H Atkins and T Bubela drafted the manuscript and approved the final version for publication.

Acknowledgements

The authors would like to thank M Hafez for development of the initial coding frame and coding clinical trials to 2009, M Bieber for technical assistance with mapping and data management, and L Dacks and M Fung for research assistance.

Financial & competing interests disclosure

This study was funded by the Stem Cell Network Strategic Core Grant (to T Bubela and H Atkins) and a Stem Cell Network Strategic Core Grant: Public Policy & ELSI (to T Bubela and H Atkins). In 2011, MD Li was awarded an Alberta Innovates Health Solutions Summer Studentship and a Stem Cell Network Social Sciences Summer Studentship. H Atkins is a stem cell transplant physician at the Ottawa Hospital Research Institute and is currently the principal investigator of a clinical trial using hematopoietic stem cell transplantation for multiple sclerosis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

This study was funded by the Stem Cell Network Strategic Core Grant (to T Bubela and H Atkins) and a Stem Cell Network Strategic Core Grant: Public Policy & ELSI (to T Bubela and H Atkins). In 2011, MD Li was awarded an Alberta Innovates Health Solutions Summer Studentship and a Stem Cell Network Social Sciences Summer Studentship. H Atkins is a stem cell transplant physician at the Ottawa Hospital Research Institute and is currently the principal investigator of a clinical trial using hematopoietic stem cell transplantation for multiple sclerosis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.