Therapeutic evaluation of all-in-one intra-articular (IA) injections of autologous platelet rich plasma (PRP) combined with hyaluronic acid (HA) for knee degenerative disorders. Material and methods: The protocol consisted in one or three IA injections, generally ultrasound guided, of a combination of PRP and HA prepared with the innovative Cellular Matrix device (CM-PRP-HA) on three cohorts of patients: A first cohort of 202 patients with meniscal lesions, comprising 93 patients with grade II or III stable meniscal tear, 59 patients after meniscal suture and 50 patients with meniscal cyst, a second cohort of 20 patients with Grade II or III osteoarthritis (OA) and a third cohort of 40 patients presenting post traumatic bone marrow edema (BME) comprising 20 patients with post-traumatic algodystrophy (PTA) and 20 patients with post-traumatic osteoarthritis (PTOA). The International Knee Documentation Committee (IKDC) subjective knee score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale as well as magnetic resonance imaging (MRI) and ultrasounds were used to assess results. Results: Patients with meniscal lesion were treated with one injection of CM-PRP-HA. The follow up evaluation was done after one year. Significant improvement in the IKDC score (79.6/100 vs. 42/100 before treatment) was observed for patients with meniscal tears. Patients with meniscal suture presented no failure, while the success rate for patients treated for meniscal cysts was 70%. Patients with degenerative OA received 3 IA injections of CM-PRP-HA at day 0, at 2 months and at 6 months. Significant difference in the WOMAC pain scale was observed during the final evaluation at 9 months compared with value at day 0 (2.45 vs. 5.65). Patients presenting post traumatic bone marrow edema were treated with one IA injection of CM-PRP-HA and evaluated after one month. The pain score decreases from 8 to 4 for PTA and PTOA patients. This result was correlated with a reduction of bone marrow edema observed with MRI. Conclusions: The Cellular Matrix device has been designed to prepare intra-articular injections of a combination of PRP and HA for symptomatic treatment of articular pain and mobility improvement, essentially for patient suffering from knee OA. In this study, other indications for this innovative treatment are also proposed. CM-PRP-HA appears to be a more efficient alternative to visco-supplementation with HA for the symptomatic treatment of knee articular disorders, including pain reduction and increase of knee functionality for patients suffering of osteoarthritis, post traumatic bone marrow edema, meniscal tears, healing of meniscal suture and size reduction of meniscal cysts. Further investigations will determine the optimal frequency of IA injections with CM-PRP-HA, and whether this innovative product would represent not only a conservative treatment for various knee articular disorders but also a preventive treatment for OA, thus delaying the need for knee surgery. Keywords: platelet-rich plasma ...
To analyze the potential modulatory effect of Cellular Matrix, a new medical device designed for the one-step preparation of platelet-rich plasma in presence of hyaluronic acid, on the structure of articular cartilage in patients suffering from knee osteoarthritis using high-field Magnetic Resonance Imaging measurements of longitudinal relaxation time after gadolinium injection. Methods: The treatment consisted of a series of 3 intra-articular injections scheduled at D0, D60 and D180 into the affected knee of six patients with Kellgren-Lawrence grades of 1.5 to 3. Magnetic Resonance Imaging acquisitions were performed before the first injection at D0 (baseline), at D180 (just after the third injection) and at D270 (3 months after the third injection). The efficacy criterion was the variation of T1 relaxation time in different selected cartilage regions. Results: Our study reveals a positive" time-dependent" structural effect of the combination of PRP and HA obtained with Cellular Matrix on the proteoglycan content of the knee joint cartilage. At D180, the weight-bearing areas were involved in two patients with Kellgren-Lawrence grades equal to or greater than 2. At D270, 5 patients showed an initial improvement in the weight-bearing area; only one patient with early external femoropatellar osteoarthritis (with a Kellgren-Lawrence grade of 1.5) had no improvement. Conclusion: This pilot study demonstrates for the first time the modulatory effect on the structure of the knee joint cartilage of a combination of platelet-rich plasma and hyaluronic acid prepared with a specially dedicated medical device (Cellular Matrix) during the course treatment. Cellular Matrix could therefore be considered a Disease Modifying Osteoarthritis Device.
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