Knee Osteoarthritis Clinical Trial
Official title:
A Prospective, Multicenter, Randomized,Controlled Study to Compare the Safety and Performance of Cellular Matrix Device (Combination of Autologous Platelet-rich Plasma and Non-crosslinked Hyaluronic Acid) to Those of Synvisc-One (Crosslinked Hyaluronic Acid) for the Treatment of Mild to Moderate Knee Osteoarthritis
This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only (Synvisc®-One).
Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood,
representing a powerful source of platelet-derived growth factors, particularly useful in the
field of regenerative medicine. The active and sequential secretion of these growth factors
induces different cell signaling cascades that activate angiogenesis, cell proliferation,
cell differentiation, eventually leading to new matrix synthesis and tissue regeneration.
The potential benefits from the use of PRP for the treatment of cartilage defects rely on a
number of studies conducted in validated animal models or in vitro, demonstrating the ability
of PRP to stimulate collagen production and proteoglycans synthesis, as well as the
proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally,
an increasing number of clinical studies shows an improvement of symptoms, most especially
pain, without any occurrence of serious adverse events.
Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the
cartilage, assumes an important role in the viscoelastic properties of the articular
cartilage, conferring its shock absorbing and lubricating functions.
It was demonstrated that rheological properties of synovial fluid decrease with aging and in
patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic
acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms,
conferring a mechanical action on joints structures, thus leading to reduced pain and
improved joint function Based on these data, it seems reasonable to hypothesize that a
combination of both PRP and hyaluronic acid could provide greater benefits compared to the
administration of each product alone, as their effects on osteoarthritis improvement are
based on different mechanisms of action. In fact, on one side PRP promotes cartilage
regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP,
providing optimal release of platelets growth factors, strengthening and extending in time
the activity of PRP.
Cellular Matrix/A-CP HA Kit is a medical device manufactured by the Swiss company Regen Lab
SA. Cellular Matrix/A-CP HA Kit allows to prepare autologous PRP combined with a
non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA
combination is intended to be injected intra-articularly, in order to relieve osteoarthritic
symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might
represent a novel therapeutic option for patient suffering from knee osteoarthritis.
This study will evaluate the effects of a single intra-articular injection of a PRP/HA
combination prepared with Cellular Matrix/A-CP HA Kit, compared to those of a intra-articular
single injection of a well-recognized hyaluronic acid treatment (Synvisc®-One), to relieve
symptoms associated with mild to moderate knee osteoarthritis.
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