Tag Archive | standardization

Stemming the Tide of Stem Cell Hype

Stem Cells for OBuzzThis post comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.

Despite the absence of research-based guidance, the use of stem cell therapies in musculoskeletal medicine has gained popularity and stimulated patient interest. Consequently, an international consensus was  recently established to develop strategies to improve standardization and transparency when describing cell therapies, and to develop a consensus on the contents of a standardized tool for describing cell therapies.1 The tool, dubbed DOSES, was an outgrowth of a call for improvement in communicating about cell-based therapies made during the American Academy of Orthopaedic Surgeons/National Institutes of Health Optimizing Clinical Use of Biologics Symposium in 2018.

The international experts used an iterative Delphi methodology to develop DOSES. The five components of the DOSES tool are Donor (i.e., autologous, allogeneic, xenogeneic), Origin of tissue (fat, bone marrow, etc.), Separation from other cell types/preparation method, Exhibited cell characteristics, and the Site of delivery. The tool should help clinicians, researchers, regulators, and industry professionals describe and communicate about any given stem cell treatment clearly and transparently.

In a commentary on the DOSES article, Scott Rodeo, MD notes that efforts are under way to clarify and classify stem cells by genomics, proteomics, metabolomics, and other approaches.2 Dr. Rodeo believes that the most important component of DOSES is the “E” category, information that will ultimately characterize the biologic activity of the cell preparation. He concludes by encouraging “clinicians, industry, and authors of both laboratory and clinical studies to begin the use of the DOSES tool, and possibly other algorithms, when communicating the results of cell therapy investigations.” This admonition carries over to journal editors, who, Dr. Rodeo says, should “consider adopting such reporting standards as mandatory for publication” of stem cell studies.

For stem cell therapy to progress clinically in the future, researchers and clinicians must apply a consistent nomenclature to describe cell therapies and actual cell formulations.3 This is lacking in today’s applications.

References

  1. Murray IR, Chahla J, Safran MR, Krych AJ, Saris DBF, Caplan AI, LaPrade RF. 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. PMID: 31094982
  2. Rodeo SA. A Call for Standardization in Cell Therapy Studies: Commentary on an article by Iain R. Murray, BMedSci(Hons), MRCS, MFSEM, PhD, et al.: “International Expert Consensus on a Cell Therapy Communication Tool: DOSES”. J Bone Joint Surg Am. 2019 May 15;101(10):e47. doi: 10.2106/JBJS.19.00189. PMID: 31094994.
  3. Jones IA, Chen X, Evseenko D, Vangsness CT Jr. Nomenclature Inconsistency and Selective Outcome Reporting Hinder Understanding of Stem Cell Therapy for the Knee. J Bone Joint Surg Am. 2019 Jan 16;101(2):186-195. doi: 10.2106/JBJS.17.01474. PMID: 30653050