Intra-Articular Injection of Adipose-Derived Stromal Vascular Fraction in Osteoarthritic Temporomandibular Joints: Study Design of a Randomized Controlled Clinical Trial

• DOI: 10.3390/bioengineering11020171
• Publication Date: 2024-02-12T08:50:27Z
• Authors: Jan Aart M. Schipper; Aartje Jorien Tuin; Joris A. van Dongen; Nico B. van Bakelen; Martin Conrad Har...; Fred K. L. Spijke...
• Keywords: Stromal vascular fraction; Clinical endpoint

Introduction: Temporomandibular joint (TMJ) osteoarthritis is a degenerative disease of the TMJ. It characterized by progressive degradation extracellular matrix components articular cartilage, with secondary inflammatory leading to pain in temporomandibular region and reduced mouth opening. Current treatments do not halt progression, hence need for new therapies reduce inflammation and, consequently, improve symptoms. The aim our randomized controlled clinical trial protocol investigate efficacy adjuvant intra-articular injections autologous tissue-like stromal vascular fraction (tSVF), compared arthrocentesis alone, reducing improving opening TMJ patients. Materials Methods: primary endpoint analysis will consist visual analogue scale (VAS) pain. analyses include maximal interincisal measurements; assessment oral health mandibular function based on impact profile (OHIP) questionnaire functional impairment (MFIQ); complications during follow up; synovial cytokine at baseline after 26 weeks; nucleated cells tSVF (immuno)histochemistry intervention group. Discussion: Our be applied evaluate promising injection therapy osteoarthritis. safety has been proven knee However, since considered heterologous application cell therapy, regulatory requirements are strict, which makes medical ethical approval challenging.