![]() ![]() With the development of tissue engineering and regenerative medicine, stem cells have emerged as a prominent area of research due to their remarkable ability to proliferate and differentiate in multiple directions, thereby promoting cartilage formation, vascularization, and anti-inflammatory and immunomodulatory effects. Therefore, novel effective treatments must be explored. Knee replacement as an effective treatment for the advanced disease has the risk of multiple complications, a high cost, and a second revision. Moreover, recently developed biological agents such as trans-capsaicin injection and lutikizumab inhibit inflammatory factors, including Interleukin (IL)-1α, IL-1β, and TNF-α however, they have limited therapeutic effects. Patients who cannot tolerate NSAIDs or fail to respond to this treatment may consider corticosteroid injections as an alternative option. Patients with dyspepsia should use a proton pump or COX-2 inhibitors, while those with a history of peptic ulcer bleeding should avoid NSAIDs altogether. Therefore, KOA patients taking anticoagulants may benefit from NSAIDs such as COX-2 inhibitors, particularly celecoxib, which does not increase bleeding risk. While NSAIDs are the first-line treatment for KOA, they have several toxicities, including gastrointestinal irritation and ulceration, bleeding, and decreased renal blood flow in azotemia. Drug therapy, such as topical or oral non-steroidal anti-inflammatory drugs (NSAIDs) and intra-articular corticosteroid injections, is a key treatment option for KOA. KOA management typically involves a comprehensive approach to symptom relief, including physical therapy, drug therapy, and surgical intervention. Most KOA patients seek treatment when they experience pain, swelling, or limited mobility in the knee joint. Aggravating pathophysiological changes, including articular cartilage destruction, subchondral bone sclerosis, cystic degeneration, and osteophyte formation, cause knee joint pain and loss of function, making KOA difficult to treat. The global prevalence of knee osteoarthritis (KOA) increases with age, with 16% of people over 15 years old and 22.9% of people over 40 years old. PROSPERO registration number: CRD42022355875. Clinical translation of stem cell therapies remains baseless and should be cautiously approached until more robust evidence is available. The inefficacy of stem cells, the risk of potential complications, and the limited quality of evidence from current studies precluded any recommendation for using stem cell products in patients with KOA. Similarly, SRs/MAs have inadequate evidence regarding study design, risk of bias assessment, outcome description, comprehensive discussion, and potential conflicts of interest. However, current clinical studies have limited evidence regarding study objectives, test designs, and patient populations. ![]() SRs/MAs results revealed that stem cell therapy relieved pain in patients over time but did not improve knee function. ![]() However, these two studies suggest that stem cell therapy does not bring significant ARs to patients. Additionally, two studies have reported cases of prostate cancer and breast tumors, respectively. Some studies reported over 10% prevalence of knee pain (24.5% 95% CI ), knee effusion (12.5% 95% CI ), and knee swelling (11.9% 95% CI ). Nineteen ARs were reported in 50 studies, including five knee-related ARs, seven common ARs, and seven other ARs. Resultsįifty clinical studies and 13 systematic reviews/meta-analyses (SRs/MAs) were included. Two researchers conducted literature screening and data extraction independently, and the evidence quality was evaluated according to the Institute of Health Economics and AMSTAR 2 criteria. Quantitative systematic reviews of stem cell therapy for KOA that conducted meta-analysis were included. ![]() Clinical studies that reported adverse reactions (ARs) of stem cell therapy in KOA patients were included without limiting the type of studies. Using “stem cells” and “knee osteoarthritis” as the search terms, several databases, including PubMed, Web of Science, Cochrane, Embase, and, were searched on August 25, 2022, and updated on February 27, 2023. A comprehensive evaluation of the safety and efficacy of stem cell therapies and scientific evidence quality is necessary. However, it remains uncertain whether the current scientific evidence supports the clinical application of stem cells in treating KOA. The success of stem cell therapy for knee osteoarthritis (KOA) in preclinical animal models has accelerated the pace of clinical translation. ![]()
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