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Monoshot™ HA+PRP kit

Monoshot™ HA+PRP kit

Monoshot™ HA+PRP kit allows to obtain a combined product of hyaluronic acid

(HA) with platelet-rich plasma (PRP), intended for intra-articular injection.

Product provides simultaneous mechanical and anti-catabolic action of HA with optimally selected physicochemical parameters and the anabolic action of growth factors secreted by platelets from PRP. Thus, clinical effectiveness of the therapy based on Monoshot™ HA+PRP is strictly linked to the combined action provided by each of its components – HA and growth factors released by PLTS.

Monoshot™ HA, with selected optimal viscoelastic properties provides not only the mechanical effect, like improved lubrication and adsorption forces acting in the joint, but it also offers the anti-inflammatory effect by reduction of tissue-degrading enzymes production, such as matrix metalloproteinases.

On the other hand, PRP obtained with the Monoshot™ PRP separation device is a highly concentrated PLT solution, characterized by platelets concentration way above 1000 000 PLT/ul – a threshold of a therapeutical effectiveness for PRP?. Growth factors secreted by such high number of PLTs in PRP provide a robust anabolic effect, initiating regeneration and rebuilding process of damaged tissues

Simultaneous intra-articular injection of HA and PRP delivers the combined and strengthened action of both kit components.

Osteoarthritis (OA) is severe synovial joint degradation disease, characterized with degradation of cartilage, subchondral bone hyperplasia and synovium inflammation. OA leads to serious impairment in joint instability and functional limitations1. For the past years, number of intra-articular therapies emerged as an effective treatment options for OA patients. Those include two most popular ones – intra-articular injections of HA or PRP.
However, the latest meta-analysis show that simultaneous intra-articular injection of HA and PRP into the OA affected joint can provide a number of biological and mechanical actions, merged in one therapy. This includes but is not limited to:
  • improved lubrication between two cartilaginous surfaces
  • improved absorption of forces acting in the joint
  • anti-catabolic action of HA via CD-44 signaling
  • initiation of the anabolic actions what in turn leads to the regeneration of damaged tissues2,3
  • anti-inflammatory action

Monoshot™ HA+PRP provides a combined intra-articular injection of HA and PRP in the 4.8 mL final volume of the product. In details, the kit contains a pre-filled syringe with a high dose of sodium hyaluronate (95 mg) in 3.8 mL volume, characterized with molecular weight ranging between 1200-3200 kDa. Furthermore, Monoshot™ kit contains an efficient separation device that aims to deliver a highly concentrated PRP. This is possible due to the fact that Monoshot™ PRP separation device is made of Makrolon® polycarbonate and is characterized with unique design and construction, allowing the separation and further isolation of a very high number of platelets (PLTs) in the final injectable product. The separation device allows to obtain PLTs concentration way above the threshold of a therapeutical effectiveness stated by PRP definition on 1 000 000 PLT/µl. This is due to ability of Monoshot™ PRP separation device to concentrate PLTs 9.7 times more than in patients peripheral blood4. Such effectiveness delivers 1 mL of highly concentrated PRP from 13.5 mL of patient’s peripheral blood.

Simultaneous intra-articular injection of the HA and PRP will deliver the strengthened and complete therapeutic action of the combined kit components. The vital advantages of Monoshot™ HA+PRP is also its safety as well as simple preparation and administration methods. Moreover, due to bacterial fermentation origin of the HA and the autologous characteristics of PRP, no unintentional immune response can be triggered after the injection of the product and no donor-recipient disease transmission is possible6.

There are also number of practical benefits of the therapy based on Monoshot™ HA+PRP when compared to HA and PRP separate injection. This includes but is not limited to:

  • more economical solution,
  • shortened injection procedure,
  • reduced patient’s traumatization.

Package of Monoshot™ HA+PRP contains:

  • Monoshot™ PRP, separation device (1 pc)
  • Butterfly needle, 21G (1 pc)
  • Needle, 21G (2 pcs)
  • Needle, 19G (1 pc)
  • Single use syringe, 20 mL (1 pc)
  • Single use syringe (with Luer-lock), 10 mL (1 pc)
  • Monoshot™ HA, 3.8 mL, 2.5% sodium hyaluronate in pre-filled syringe (1 pc)
The product is meant to be used by medical practitioners only.
Therapeutical efficiency of intra-articular injection of HA and PRP combination
Since OA is a very complex and at the same time a rapidly progressive disease – involving metabolic, genetic, and biomechanical risk factors, no effective therapies, able to fully cure the disease have been found yet. Nevertheless, modern medicine offers a several intra-articularly injectable products, able to relieve symptoms and finally delay the progression of the disease. From those the most efficient ones are hyaluronic acid (HA) and platelet-rich plasma (PRP) injections – therapies with the highest number of clinical verifications1.
HA is one of the major fundamental component of articular cartilage extracellular matrix and synovial fluid. HA is a biopolysacharide – it consists of a number of sugar molecules bonded together into a long chain2. HA as a crucial functional element of synovial joint acts as a lubricant, shock absorber, filler and metabolic agent3. Importantly, during OA development the lubricating and shock absorbing abilities of synovial fluid are diminished – mainly by distinctive degradation of naturally produced HA4. Thus, clinical data show that viscosupplementation, so intra-articular injection of HA, is scientifically and clinically approved practice for reducing joint pain, improving functional condition of OA-affected joint, protecting cartilage and finally delaying progression of the disease5.

PRP is a concentrated and isolated fraction of the blood, which contains a high amount of platelets (PLTs). In turn, the growth factors released by the PLTs, act as a natural signaling molecules for the cells and tissues and thus provide the necessary molecular information at the injury and damage site. Up to date, more than 300 biologically active molecules were identified in the platelet secretome6. Among all, the signaling proteins like growth factors are closely linked with the beneficial effects of the PRP therapy – including platelet derived growth factors (PDGF), transforming growth factor β1 (TGF- β1), insulin-like growth factor 1 (IGF-1), fibroblast growth factor 2 (FGF-2), hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF)7 and many more.

One of the crucial effects of PLT-derived growth factors in general can be describes as anti-inflammatory when applied into the OA affected joint. This anti-inflammatory effect lays mainly in the ability of PRP to inhibit the production of proinflammatory cytokines, such as IL-6 and IL-88.

Foremost, PRP with high concentration of PLTs and thus loads of different growth factors has been described as potent modulator of cell metabolism in OA-affected joint. Growth factors secreted by the PLTs can induce the production and secretion of articular cartilage tissue extracellular matrix (ECM) components like ACAN, COL2A1 and HA, leading to the elevated biosynthesis of ECM components9. By this mechanism PRP will contribute significantly to the increase in regeneration processes of the articular cartilage tissue.

All the mentioned effects makes the combined injections of HA and PRP a highly recommendable therapy for OA-affected joints. Based on recent meta-analysis, the therapy based on combined HA and PRP intra-articular injection was presented as a therapeutically effective against OA with reduction of the level of perceived pain as well as improvement of the joint mobility and physical function more effectively than both preparations administered independently, up to 52 weeks10.

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