Abstract:BackgroundSeveral hyaluronan preparations are available that have different dosage forms, origins, and concentrations. The objective of the study was to compare the efficacy of intra-articular chemically cross-linked hyaluronan (CCH) and avian-derived hyaluronan (ADH) injections in knee osteoarthritis (KOA) patients.Material/MethodsIn total, 258 patients were randomized into 2 groups of 129 each: patients who received CCH injection (CCH group) and patients who received ADH injection (ADH group). Radiographic K… Show more
“…All reported cases resolved within a few days and no patient had to terminate any of the trials preliminary due to safety issues. Moreover, reported AEs were similar to those previously reported during clinical trials, evaluating intra-articular injections of HA or GC [111,112]. It can therefore be assumed that treatment-related AEs are of procedural nature and that intra-articular MSC injections are safe, regardless of tissue origin and applied cell dose.…”
Osteoarthritis (OA) is the most common degenerative joint disorder worldwide and to date no regenerative treatment has been established in clinical practice. This review evaluates the current literature on the clinical translation of mesenchymal stromal cell (MSC)-based therapy in OA management with a focus on safety, outcomes and procedural specifics. PubMed, Cochrane Library and clinicaltrials.gov were searched for clinical studies using MSCs for OA treatment. 290 articles were initially identified and 42 articles of interest, including a total of 1325 patients, remained for further examination. Most of the included studies used adipose tissue-derived MSCs or bone-marrow-derived MSCs to treat patients suffering from knee OA. MSC-based therapy for knee OA appears to be safe and presumably effective in selected parameters. Yet, a direct comparison between studies was difficult due to a pronounced variance regarding methodology, assessed outcomes and evidence levels. Intensive scientific engagement is needed to identify the most effective source and dosage of MSCs for OA treatment in the future. Consent on outcome measures has to be reached and eventually patient sub-populations need to be identified that will profit most from MSC-based treatment for OA.
“…All reported cases resolved within a few days and no patient had to terminate any of the trials preliminary due to safety issues. Moreover, reported AEs were similar to those previously reported during clinical trials, evaluating intra-articular injections of HA or GC [111,112]. It can therefore be assumed that treatment-related AEs are of procedural nature and that intra-articular MSC injections are safe, regardless of tissue origin and applied cell dose.…”
Osteoarthritis (OA) is the most common degenerative joint disorder worldwide and to date no regenerative treatment has been established in clinical practice. This review evaluates the current literature on the clinical translation of mesenchymal stromal cell (MSC)-based therapy in OA management with a focus on safety, outcomes and procedural specifics. PubMed, Cochrane Library and clinicaltrials.gov were searched for clinical studies using MSCs for OA treatment. 290 articles were initially identified and 42 articles of interest, including a total of 1325 patients, remained for further examination. Most of the included studies used adipose tissue-derived MSCs or bone-marrow-derived MSCs to treat patients suffering from knee OA. MSC-based therapy for knee OA appears to be safe and presumably effective in selected parameters. Yet, a direct comparison between studies was difficult due to a pronounced variance regarding methodology, assessed outcomes and evidence levels. Intensive scientific engagement is needed to identify the most effective source and dosage of MSCs for OA treatment in the future. Consent on outcome measures has to be reached and eventually patient sub-populations need to be identified that will profit most from MSC-based treatment for OA.
“…HA, produced by synoviocytes and chondrocytes, is the primary component of synovial joint fluid. A healthy knee contains ~ 2 ml of synovial fluid with an HA concentration of 2.5–4.0 mg/ml [ 12 ]. In fact, it acts as a lubricant and shock absorber, protecting the articular cartilage and joint structures from compressive and shear forces, thereby reducing articular cartilage wear.…”
Section: Introductionmentioning
confidence: 99%
“…The synovial fluid’s rheological properties, i.e., viscosity and elasticity, decrease over time because the concentration of HA and the average molecular weight (MW) decrease over time. Osteoarthritis leads to the progressive deterioration of articular cartilage [ 12 , 13 ]. In addition to the viscoelastic properties of HA, the molecule has demonstrated anti-inflammatory properties, such as the inhibition of phagocytosis and reduction of inflammatory mediators [ 13 ].…”
Introduction: Several viscosupplement treatments are available for patients suffering from painful osteoarthritis (OA) of the knee, but few comparative clinical trials have been conducted. The primary objective of the trial was to demonstrate the non-inferiority of Synolis VA (80 mg hyaluronic acid and 160 mg sorbitol) (Group HA1) to Synvisc-One (48 mg hylan GF-20) (Group HA2) at Day 168 in terms of pain relief efficacy in patients with knee OA (Kellgren and Lawrence radiological stage II or III) in whom oral treatment with analgesics, NSAIDs or weak opioids provided insufficient clinical responses or were poorly tolerated.Methods: This was a prospective, multicentre, comparative, randomized, double-blinded trial comparing the two previously indicated viscosupplements, HA1 and HA2. The average VAS pain score (1-100) was 62.5 at baseline (Day 0). The patients were randomized into two parallel groups at Day 0 and followed until Day 168. They received one injection of either HA1 or HA2. The primary end point was the evolution of the Western Ontario and McMaster University (WOMAC) pain index at D168 in the groups. One of the secondary end points was the daily assessment of this index by the patient for 7 days following the injection and thereafter at Day 14. The other secondary end points were the WOMAC pain, stiffness, function and total scores assessed at Day 28, Day 84 and Day 168. At Day 168, efficacy and satisfaction were assessed by the evaluator and by the patient using a Likert scale (7 points). Moreover, the number of strict responders in each group was evaluated according to the The Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT) criteria (OMERACT-OARSI). The per protocol (PP) population was used for the primary analysis. Results: A total of 202 patients were randomized. The patients were predominantly female (66%). The median age of the whole population was 65 years, and the median body mass index was 27.4 kg/m 2 . No statistically significant
“…3) [34]. In a randomized, double-blind trial, patients treated with chemically cross-linked hyaluronan had improved pain scores compared to patients treated with avian-derived hyaluronan [35]. Fig.…”
Introduction: Knee osteoarthritis (OA) is a progressive degenerative condition and is a significant contributor toward physical disability in the aging population. The current
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