Intra-Articular Injection of Adipose-Derived Stromal Vascular Fraction in Osteoarthritic Temporomandibular Joints: Study Design of a Randomized Controlled Clinical Trial.
Jan Aart M SchipperAartje Jorien TuinJoris Anton van DongenNicolaas B Van BakelenMartim Conrad HarmsenFred K L SpijkervetPublished in: Bioengineering (Basel, Switzerland) (2024)
Our randomized clinical trial protocol will be applied to evaluate the efficacy of a new promising tSVF injection therapy for TMJ osteoarthritis. The safety of intra-articular injections of tSVF has been proven for knee osteoarthritis. However, since a tSVF injection is considered a heterologous application of cell therapy, the regulatory requirements are strict, which makes medical ethical approval challenging.