A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen – interim findings of a double-blind clinical study

Abstract

Objective Osteoarthritis (OA) is a widespread degenerative joint disease leading to progressive loss of function and pain. Available treatments do not provide long-term relief or improvement. This study aimed to assess the safety and efficacy of a novel intra articular supplement, made of high molecular-weight hyaluronic acid (HA) uniquely conjugated to either purified (RegenoGel) or autologous plasma-derived fibrinogen (RegenoGel-OSP), as a long-term treatment for knee OA. Methods Sixty-seven consecutive participants (mean age 67.26 ± 7 years) with symptomatic OA were randomly assigned to receive intraarticular injections of either RegenoGel, RegenoGel-OSP or saline solution (placebo). The active treatment groups received a second, repeat injection of the corresponding treatment at the 3-month evaluation, at which time, the placebo group was divided into two subgroups, one receiving RegenoGel and the other receiving RegenoGel-OSP. The OA symptoms were assessed by VAS, WOMAC, and IKDC questionnaires at baseline and at 1, 3, 4, and 6 months following the first injection. OA-related quality of life was evaluated by the SF-12 survey. Results Our preliminary data suggests that both fibrin-HA formulations have positive effects on OA symptoms for all assessed parameters with the most prominent trend for reduction in OA-associated pain. Pooled data analysis of RegenoGel and RegenoGel-OSP shows significantly improved VAS scores compared to placebo at three months after the first injection, and sustained for another three months after the second injection. Both RegenoGel, RegenoGel-OSP had an excellent safety profile. Conclusions Interim analysis results indicate that RegenoGel and RegenoGel-OSP are safe and are potentially effective for at least six months in alleviating pain and symptoms of knee OA.

Nano-ghosts: Novel biomimetic nano-vesicles for the delivery of antisense oligonucleotides

“…[39][40][41][42] Here, we have shown that the integration of the NGs with HA-FB hydrogel enabled uptake of endogenous cells in vivo. The hydrogel used was Regenogel™, a hydrogel that previously showed positive results in cartilage defect models [43] and it is clinically proved in Israel as a treatment to relieve pain in osteoarthritis patients [44] and it is approved in Israel for osteoarthritis treatment. Moreover, this hydrogel was previously used to deliver antimiR-221 using lipofectamine as a carrier system [45].…”

Design and clinical application of injectable hydrogels for musculoskeletal therapy

“…An example of this is ProCore's RegenoGel® solution that was commercially approved in Israel in 2016 and recently completed their FDA phase 4 clinical trials. RegenoGel® is based on HA that is mixed with purified platelet‐rich plasma‐derived fibrinogen that conjugates to form an injectable gel 70 . In their clinical trials, they have been able to demonstrate that the gel is efficient at treating the symptoms of OA, that is, pain and knee stiffness, for at least 6 months after treatment start, 70 but more detailed studies are required to investigate the long‐term effect and the ability to regenerate cartilage.…”

Sports Medicine and Movement Sciences

“…This Special Issue bridging the gap between science and practice in the promotion of exercise and health and in the scientific assessment, study, and understanding of sports performance, sports injury prevention and treatment, exercise for health as non-surgical and nonpharmacological treatments, rehabilitation techniques, adapted physical activity, drugs in sport, and recommendations for training and nutrition. This Special issue comprises 3 review articles and 16 original research publications from a number of Sports Medicine and Sciences researchers [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. Taken together, these articles are…”

“…This Special issue comprises 3 review articles and 16 original research publications from a number of Sports Medicine and Movement Sciences researchers [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ]. Taken together, these articles are geared toward the advancement of our understanding Sports Medicine and Movement Sciences arena, including: Cognitive function; Brain health; Gait analysis; Biomechanics; Health sciences; Physiology; Physical activity; Occupational health; Musculoskeletal system; Evidence-based medicine; Aerobic threshold; Anaerobic threshold; Maximal oxygen uptake; Neuroscience; Exercise; Physical Activity; Balance; Metastability; Neuromuscular control; Prevention; Rehabilitation; Health Promotion; Anatomy; Health Technology; Three-dimensional motion analysis; Reliability; knee injury; Athletic pubalgia; Cardiology; Women's Health; Female athletes; Applied psychology; Clinical psychology; Paralympic sport; Goalball; Soccer; Cognitive psychology; Quality of life; Disability; Regenerative medicine; Osteoarthritis; Virtual reality; Sensorimotor control; Sports injury prevention; Epidemiology; Public health; Psychology; COVID-19; Pandemic; Quarantine; Home based exercise; IPAQ-SF; Psychological well-being; PGWBI; Nerve injury; Nerve regeneration; Therapeutic exercise; Wearable technologies; Sprint initiation; Step technique; Multi-directional movement; Novel training environments and digital devices; Adherence; Breast cancer; Lifestyle; Public Health and Digital Epidemiology.…”