Cell therapies, including stem cells, are increasingly being marketed and used for the treatment of musculoskeletal disorders, despite questions about the treatments and their effectiveness.
A new tool called DOSES has been developed by an international panel of experts to help clarify some of the conflicting and confusing information by providing standards for describing the characteristics and uses of cell therapies.
“The use of this tool may allow clinicians and patients to better understand the characteristics of current and future cell preparations,” according to Robert F. LaPrade, MD, PhD. Dr. LaPrade, from The Steadman Clinic in Vail, Colorado, is the lead author of a paper on DOSES published in The Journal of Bone and Joint Surgeons.
The DOSES tool was designed to meet the need for more transparent, standardized communication in describing cell therapies – often marketed as stem cells – for musculoskeletal conditions. “Misleading or ambiguous terminology can result in mistaken assumptions regarding cell origins and characteristics, making interpretation of studies difficult,” Dr. LaPrade and colleagues write in the article. “A lack of standards for conveying the characteristics of cell therapies is being increasingly exploited with misinformation of unproven treatments.”
An expert working group of 34 clinicians and researchers followed a formal process to reach consensus (more than 80% agreement) on the essential information needed when communicating about cell therapies. The resulting DOSES tool addresses 5 areas that should be included whenever cell therapies are described or reported on:
- Donor: The source of cells (eg, allogeneic or autologous)
- Origin: The type of tissue from which cells were obtained (eg, fat or bone marrow)
- Separation: The methods used to prepare the cells or separate them from other tissues
- Exhibited cell characteristics: The biologic activity that is believed to affect the therapeutic behavior of the cells
- Site of delivery: The site where the cells are administered (eg, intravenously or intraarticularly)
These 5 elements should be used in describing cell therapies at every step: from initial scientific reports through product marketing and clinical use, the expert panel said. “The DOSES tool can be utilized by researchers, clinicians, regulators, and industry professionals to improve standardization and transparency when describing cell therapies,” they write in the article.
They also believe that research journals should make these “core descriptors” mandatory in studies reporting cell therapies.
The DOSES tool provides a much-needed set of standard descriptors, at a time when stem cells and other cell therapies are being aggressively marked to consumers and professionals – often without meaningful supporting data.
“Clinical research and practice are being undermined by ambiguous terminology that acts as a barrier to understanding the basic attributes of cell therapies,” the authors write. “The present study has established consensus on the requirement for a descriptive tool to improve cell therapy communication.”
Murray IR, Chahla J, Safran MR, et al. International expert consensus on a cell therapy communication tool: DOSES. J Bone Joint Surg Am. 2019 May 15;101(10):904-911. doi: 10.2106/JBJS.18.00915.