Orthopedic stem cell treatment and orthobiologics is increasingly coming under fire from academic bench scientists who believe there is not enough research nor practice standards. While recent attempts like the DOSES Delphi panel have attempted to describe benchmarks for the cellular composition of orthobiologics, there are no practice guidelines and as a result, the field has been described as "The Wild West."
The group will drive consensus on practice items such as the use of a treatment registry, publishing results, candidacy grading, level of published data needed before treatment can begin, informed consent, advertising, and use of imaging guidance. The group currently consists of experts from Stanford, Mayo Clinic, Harvard, Cornell, Hospital for Special Surgery, Emory and multiple other institutions.
"This is the first of its kind Delphi panel in orthobiologics aiming to tame the wild west," said Christopher Centeno, M.D., organizer of the Delphi panel and past president of the Interventional Orthopedics Foundation and chief medical officer of Regenexx. "We desperately need best practices that multiple academics can agree upon."
Ken Mautner, M.D., an associate professor in the Department of Physical Medicine and Rehabilitation and the Department of Orthopedic Surgery at Emory University, also a steering committee member of the consensus panel, stated, "The future of regenerative medicine is an exciting area with vast potential. Unfortunately, right now there are few standards across the country of how we should be using this technology, and this is creating a 'free for all' for providers who are not experts to perform these procedures, some of which are totally unproven at this point. Our goal is to start to create guidelines and consensus to bring some order to this field and set the stage for future research and advancements."
Greg Lutz, physiatrist-in-chief emeritus at the Hospital for Special Surgery (HSS) and a professor of Clinical Rehabilitation Medicine at Weill Medical College of Cornell University, added, "Regenerative medicine offers the hope of a cure for many previously incurable orthopedic conditions, such as degenerative disc disease. However, this will only occur with rigorous scientific studies, innovation and collaboration among leaders in the field. Patients are seeking these therapies from reputable physicians and institutions who are prioritizing this approach."
The Delphi panel will continue the process of consensus building and guidelines on the procedural use of bone marrow concentrate through the summer of 2019. More than 20 different universities are represented on the panel.