DENVER, Oct. 8, 2019 /PRNewswire/ -- The SAFE (Stem cell experts Advocating For Ethical treatment) study group, a panel that consisted of 27 academics and Regenerative Medicine physician experts from a dozen universities and from many different specialties, have just produced the world's first consensus recommendations for the use of bone marrow stem cell treatments for orthopedic injuries.
"Our goal was to create guidelines for ethical physician practice in this area," stated Christopher Centeno, M.D., founder of the Denver-based Interventional Orthopedics Foundation, and one of the two dozen panel members.
The panel used the Delphi process to recommend that clinics use treatment registries, candidacy grades, expanded informed consent, publish their results where appropriate, avoid advertising that isn't based in science, use an IRB for new clinical indications, avoid using mid-levels like nurse practitioners or physician assistants without direct supervision, and use imaging guidance to inject cells.
"These guidelines can help protect patients by laying out a set of standards for orthopedic use of bone marrow stem cell procedures," stated panel member Greg Lutz, M.D., physiatrist-in-chief emeritus at Hospital for Special Surgery (HSS) and a professor of clinical rehabilitation medicine at Weill Medical College of Cornell University.
"These guidelines will establish evidence-based clinical practices in order to provide the most effective care for patients," relayed panel member Ken Mautner, M.D., adjunct professor, Department of Physical Therapy, Mercer University, assistant professor, Department of Orthopedics and PM&R, Emory University.
The group is now working with multiple physician professional organizations to adopt the recommendations or use them to create their own practice guidelines. The SAFE group came together out of concern that patients were not getting high-quality orthobiologics care.
Orthobiologics is a field of medicine where substances are injected or implanted that can promote tissue healing. For example, many alternative medicine clinics are advertising live stem cells treatments from birth tissues, even though multiple independent tests show that these commercially available amniotic and umbilical cord products contain no live stem cells. It's the goal of this group to review many different orthobiologic therapies and make recommendations for best practices.
SOURCE Interventional Orthopedics Foundation