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

Introduction: Temporomandibular joint (TMJ) osteoarthritis is a degenerative disease of the TMJ. It is characterized by progressive degradation of the extracellular matrix components of articular cartilage, with secondary inflammatory components leading to pain in the temporomandibular region and re...

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Veröffentlicht in:Bioengineering (Basel) Jg. 11; H. 2; S. 171
Hauptverfasser: Schipper, Jan Aart M., Tuin, Aartje Jorien, van Dongen, Joris A., van Bakelen, Nico B., Harmsen, Martin Conrad, Spijkervet, Fred K. L.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Switzerland MDPI AG 01.02.2024
Schlagworte:
adipose derived stromal cells
adipose tissue
Adipose tissues
Analysis
Arthritis
Body fat
Care and treatment
Cartilage
Cartilage (articular)
Cartilage diseases
Case studies
Cell therapy
Clinical trials
Cytokines
Effectiveness
Enzymes
Extracellular matrix
Histochemistry
Inflammation
Injection
intra-articular injection
Joint diseases
Knee
Liposuction
Mandible
Maxillofacial surgery
Mouth
Oral hygiene
Osteoarthritis
Pain
Questionnaires
Signs and symptoms
Surgeons
Temporomandibular joint
Temporomandibular joint disorders
temporomandibular joint osteoarthritis
tissue stromal vascular fraction
Netherlands
temporomandibular joint osteoarthritis
adipose tissue
tissue stromal vascular fraction
intra-articular injection
adipose derived stromal cells
ISSN:2306-5354, 2306-5354
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Zusammenfassung:Introduction: Temporomandibular joint (TMJ) osteoarthritis is a degenerative disease of the TMJ. It is characterized by progressive degradation of the extracellular matrix components of articular cartilage, with secondary inflammatory components leading to pain in the temporomandibular region and reduced mouth opening. Current treatments do not halt disease progression, hence the need for new therapies to reduce inflammation and, consequently, improve symptoms. The aim of our randomized controlled clinical trial protocol is to investigate the efficacy of adjuvant intra-articular injections of autologous tissue-like stromal vascular fraction (tSVF), compared to arthrocentesis alone, in reducing pain and improving mouth opening in TMJ osteoarthritis patients. Materials and Methods: The primary endpoint analysis will consist of the visual analogue scale (VAS) for pain. The secondary endpoint analyses will include maximal interincisal mouth opening measurements; assessment of oral health and mandibular function based on the oral health impact profile (OHIP) questionnaire and mandibular functional impairment questionnaire (MFIQ); complications during the follow up; synovial cytokine analysis at baseline and after 26 weeks; and nucleated cells and tSVF (immuno)histochemistry analyses of the intervention group. Discussion: 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.
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SourceType-Scholarly Journals-1
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ISSN:2306-5354
2306-5354
DOI:10.3390/bioengineering11020171