Commercial Products for Osteochondral Tissue Repair and Regeneration

Abstract

The osteochondral tissue represents a complex structure composed of four interconnected structures, namely hyaline cartilage, a thin layer of calcified cartilage, subchondral bone, and cancellous bone. Due to the several difficulties associated with its repair and regeneration, researchers have developed several studies aiming to restore the native tissue, some of which had led to tissue-engineered commercial products. In this sense, this chapter discusses the good manufacturing practices, regulatory medical conditions and challenges on clinical translations that should be fulfilled regarding the safety and efficacy of the new commercialized products. Furthermore, we review the current osteochondral products that are currently being marketed and applied in the clinical setting, emphasizing the advantages and difficulties of each one.

Tough and Low Friction Polyvinyl Alcohol Hydrogels Loaded with Anti-inflammatories for Cartilage Replacement

“…These may go from simple and non-invasive procedures, such as the use of physiotherapy to strengthen the surrounding muscles and anti-inflammatory drugs to reduce pain and swelling, to resurfacing or even total joint replacement, when the patient's symptoms are already so severe that there is no alternative but surgical intervention [2]. In the latter case, and in a more conservative perspective, some clinicians are opting to use tissue engineering and regenerative medicine products or synthetic cartilage materials to substitute the damaged parts rather than replace the entire joint [3,4]. Synthetic materials are easily controllable and reproducible and minimize the risk of infections, as they do not contain substances derived from human or animal tissues.…”

“…Synthetic materials are easily controllable and reproducible and minimize the risk of infections, as they do not contain substances derived from human or animal tissues. They have been used in a few commercial products [4]. For example, SaluCartilage™ (SaluMedica), a cylindrical device made of polyvinyl alcohol (PVA) hydrogel that mimics the swelling of human cartilage, shows no evidence of an inflammatory reaction or osteolysis and leads to a clear improvement of chondral defects.…”

Osteochondral Tissue Engineering: The Potential of Electrospinning and Additive Manufacturing

“…Finally, the clinical trials and regulatory obstacles that need to be overcome before a new product is applied clinically and commercialised, along with the inevitable high costs associated, are another critical aspect that contributes to an extended time-to-market [ 362 ]. Although there are some promising examples of tissue-engineered OC products available on the market (as thoroughly reviewed by [ 42 , 363 ]), their use is still not consensual and widespread among the orthopaedic medical community. Their design is often based on bi/triphasic cell-free scaffold strategies that cannot fully replicate the native complexity of the OC unit and thereby struggle to achieve functional repair and regeneration of damaged OC tissue.…”

Material‐Assisted Strategies for Osteochondral Defect Repair

“…[16] Several biomaterials have now reached the market for OC defect repair, including monolayer (e.g., TruFit, BST-Cargel, Bioseed-C, Collagraft) and bilayer (e.g., ChondroMimetic, MaioRegen, Agili-C, OsseoFit plug) systems, and can be used as delivery vehicles for drug and/or cell delivery. [17] However, even though these current clinical treatments have a positive impact on joint mobility and pain reduction, they only lead to the formation of fibrocartilaginous neotissues that are not completely functional, as their mechanical properties are inferior to those of native cartilage. [18] Taking advantage of new progress in biomaterial and cellbased tissue engineering, the possibility to combine different matrices, cell types, and bioactive molecules has opened new promising avenues for OC regeneration.…”