Biologic Association aims to provide high-level evidence on regenerative medicine
At the end of 2017, with the demand for the use of biologics in orthopedics outstripping the science as well as the safety and efficacy information available, leaders of the Arthroscopy Association of North American, the American Orthopaedic Society for Sports Medicine and the International Cartilage Regeneration and Joint Preservation Society formed the Biologic Association to provide high-level evidence to physicians and patients and to advance this treatment.
“We felt it was important for us to get into the biologics space and to establish some criteria for research, analysis, establishing registries and for promulgating this information through scholarly activities and meetings,” Louis F. McIntyre, MD, Chief Quality Officer for U.S. Orthopedic Partners, told Healio Orthopedics.
According to Kenneth R. Zaslav, MD, secretary general of the Biologic Association and past president of the ICRS, the organization consists of two types of members: medical societies and individual experts. Since its inception, the Biologic Association has recruited additional societies with similar interests in the biologics specialty.
“We brought in the ON Foundation, which is the Ortho Regenerative Network, a non-profit based out of Europe that we have had a relationship with. They are interested in this space also, so they are part of our organization,” McIntyre, who is an Orthopedics Today Editorial Board Member, said. “We also would be interested in having the American Academy of Orthopaedic Surgeons involved too, and there are many different ways that we can do that and discussions are ongoing.”
Jason L. Dragoo, MD, co-chair of the Biologic Association along with Bert R. Mandelbaum, MD, added the association recently included the American Medical Society of Sports Medicine as a society member of the Biologic Association, and seeks to include additional interested societies in the future.
“Going forward we are hoping to increase our network of societies within the association because we know the more societies we have, and the more members that are a part of our society, the more impact that we will have from a worldwide perspective,” Dragoo, professor and vice chair of the department of orthopedic surgery at the University of Colorado, said.
Zaslav added the group has also reached out to experts around the world as scientific and clinical consultants to be involved in the Biologic Association. While the Biologic Association is already associated with a wide range of thought leaders and experts in biologic medicine, Dragoo said the association is looking to expand its reach and involve more experts from around the world.
“We want to be as encompassing as we can to get as many of the worldwide thought leaders as possible, and I think one of the major objectives is to make this an international association,” Dragoo said. “Although we have members from Japan, Italy, France and areas throughout the globe, we want more of the world’s biologics thought leaders in our association.”
Regenerative medicine education
On Feb. 6-7, 2020, the Biologic Association held its first summit meeting in Carlsbad, California, which included didactic lectures, panels and hands-on instruction, according to McIntyre.
A two-part meeting, Zaslav noted the first part of the meeting involved a panel of medical and investment experts evaluating and grading regenerative medical products pitched by companies based on presentation and potential success of the product.
“It was interesting because you got a good sense of what investors are looking for, what physicians are looking for and what might be new on the horizon,” said Zaslav, who is currently an orthopedic surgeon at OrthoVirginia and clinical professor of orthopedic surgery at Virginia Commonwealth University, and who will be joining the faculty at Northwell Lenox Hill Hospital later this year.
The second part of the meeting focused on the academic area of biologics, with speakers from all around the world presenting on the current appropriate and inappropriate use of platelet-rich plasma, adipose derived tissues and bone marrow aspirate concentrate, according to Zaslav.
“While we spoke a lot about the hope and the future of orthobiologics in the regenerative medicine orthopedics space, we also spoke about the current indications, what data exist and what studies need to be done to further prove the potential hope of these exciting new treatments,” Zaslav said. “We talked a lot about protecting patients from unscrupulous people who are making claims that have no data.”
In the future, Dragoo noted they plan to continue hosting educational meetings with the hope of expanding the number of scientific meetings per year.
“Right now we just have the one summit meeting, which is typically every February, but we are looking to expand to one additional meeting that could be a part of a preexisting meeting, such as the AOSSM annual meeting, AANA, etc.,” Dragoo said.
Standardized treatment protocols
regenerative medicine, Dragoo noted the Biologic Association is developing regenerative medicine standards for the medical community to follow to stop practitioners with no background or education in biologic medicine from providing injections to patients.
“We hope we can disseminate minimum requirements that practitioners should have with regard to education and maintenance of education within the area of regenerative medicine,” Dragoo said.
Standardized research and clinical protocols will be formed through the collection of outcomes from registry data supplied by large centers, according to Zaslav.
“We are setting up registries at some of the bigger centers to start in the next coming year,” Zaslav said. “Once these test centers show that this can be done appropriately, we will be spreading it out to wider use to have anybody who wants to join it ultimately to put data in concerning [platelet-rich plasma] PRP first and then following up with other orthobiologics to follow.”
In addition, the Biologic Association is working with John M. Tokish, MD, at Mayo Clinic to establish a repository to store samples for future testing, according to McIntyre.
As the Biologic Association continues to obtain members, Dragoo said the association also plans to increase advocacy for the responsible use of biologics by partnering with the FDA and Federal Trade Commission.
“If we have the thought leaders, then the FDA certainly could bounce off ideas to our association as new technology comes out, etc.,” Dragoo said. “At this time, we would love to discuss the clinician’s perspective with the FDA. We think this would be a good exchange.”
Dragoo added the association plans on providing education on regenerative medicine for patients to differentiate between real and fake information.
“We are starting a social media campaign so we can better educate non-medically educated people on regenerative medicine, the true data and the expectations that they should have if they are going to undergo treatment, as well as some of the warnings to be looking for, for unscrupulous clinics, etc., that may not be delivering real products,” Dragoo said. – by Casey Tingle
Disclosures: McIntyre reports he is a consultant for Smith & Nephew and Embody Inc. Zaslav reports he receives funding as a clinical study site from Organogenesis and MiMedx. Dragoo reports no relevant financial disclosures.