The American Academy of Orthopaedic Surgeons collaborated with the National Institutes of Arthritis, Musculoskeletal, and Skin Diseases to hold a symposium Feb. 15 through Feb. 17 at Stanford (Calif.) University on optimizing the use of biologics in orthopedic surgery.
Here are five things to know.
1. The symposium aimed to establish a clear impact agenda for the clinical evaluation, use and optimization of biologics in orthopedics. It also aimed to develop a guidance document on clinically meaningful endpoints and outcome metrics for evaluating the use of biologics to treat common orthopedic problems.
2. Attendees stressed the need to clarify terminology surrounding the types of biologics products being used, particularly the use of the term "stem cell." They also divided cell therapies into the following categories:
- Uncharacterized: minimally manipulated products roughly corresponding to the FDA 361 pathway
- Characterized: laboratory-evaluated, require FDA 351 clearance
Uncharacterized products are widely marketed as stem cells in the U.S., although their cellular and protein composition is unknown.
3. The symposium highlighted the need for clear standards and guidelines on reporting requirements for clinical studies involving platelet-rich plasma, as well as characterized and uncharacterized cell products.
4. The symposium examined the potential use of registries and biorepository-linked registries to generate clinical evidence on the use of biologics in orthopedics. For reliable, high-quality clinical data, multi-center prospective clinical trials are needed.
5. A patient panel highlighted the need for effective treatments for musculoskeletal pain, particularly due to degenerative conditions such as tendinopathy and osteoarthritis. Attendees discussed international models for accelerating regulatory approval for characterized cell therapies and the role of a registry in assisting with post-market surveillance of products approved through an accelerated process, which requires additional evaluation.
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