Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis.

Knee osteoarthritis (KOA) is a prevalent condition characterized by the progressive deterioration of the entire joint and has emerged as a prominent contributor to disability on a global scale. The nature of the disease and its impact on joint function significantly limit mobility and daily activities, highlighting its substantial influence on patients' overall well-being. Stromal vascular fraction (SVF) is a heterogenous, autologous cell product, containing mesenchymal stem cells, derived from the patient's subcutaneous adipose tissue with demonstrated safety and efficacy in the treatment of KOA patients. We conducted a single-arm, open-label, multisite, FDA approved clinical study in Kellgren-Lawrence severity grade 2-4 KOA patients. The cellular product was manufactured from patient-specific lipoaspirate in a centrally located FDA-compliant manufacturing facility. Twenty-nine subjects were treated with a quality tested single intra-articular injection of GMP manufactured SVF. Adverse events, laboratory values, vital signs, and physical examination findings were monitored during the study period. Robust tolerability, without any substantial safety issues, was demonstrated. Knee pain and function, assessed through the Knee Injury and Osteoarthritis Outcome Score (KOOS), demonstrated notable improvements. These positive benefits persisted for up to 12 months, and the majority of participants expressed satisfaction. SVF from each patient was stored in a liquid nitrogen freezer for future clinical treatments. Unique to this study of autologous cells is the shipment of lipoaspirate from the clinic to a central FDA-compliant manufacturing facility for cleanroom-controlled manufacturing. The cell product characterization data demonstrate that this method produces an equivalent product in terms of cell count and viability with the added benefit of further quality assurance testing, including sterility, endotoxin, and flow cytometry, before patient administration. Clinical Trial Registration Number: NCT04043819.

Use of extracorporeal shockwave therapies for athletes and physically active individuals: a systematic review.

OBJECTIVE: To determine the efficacy of extracorporeal shockwave therapy (ESWT) and investigate outcomes following the use of ESWT for athletes and physically active individuals. DESIGN: Systematic review. DATA SOURCES: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and searched four databases: PubMed (NLM), Embase (Elsevier), CINAHL Complete (EBSCO) and Web of Science (Clarivate). ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Included studies were randomised controlled trials, cohort and case-control studies, cases series and reports that evaluated outcomes following ESWT for athletes, physically active individuals and occupational groups requiring regular physical activity such as military cadets. RESULTS: 56 studies with 1874 athletes or physically active individuals were included. Using the Oxford level of evidence rating, included studies were 18 level I (32.1%), 3 level II (5.4%), 10 level III (17.9%), 13 level IV (23.2%) and 12 level V (21.4%). Based on the level I studies, ESWT may be effective alone in plantar fasciitis, lateral epicondylitis and proximal hamstring tendinopathy and as an adjunct to exercise treatment in medial tibial stress syndrome and osteitis pubis in athletes or physically active individuals. In most studies, athletes were allowed to continue activities and training and tolerated ESWT with minimal side effects. CONCLUSION: ESWT may offer an efficacious treatment alone or as an adjunct to concurrent exercise therapy in selected sports-related injuries and without major adverse events. Further high-level research is needed to better define the role and clinical outcomes of ESWT.