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Orthobiologics in sports medicine: an overview of the market

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1 Orthobiologics in sports medicine: an overview of the market
Catherine Coveney Biosport Project, University of Sussex

2 Aim To identify the range of emerging biomedical sport-related diagnostic and repair technologies, and their producers, in musculoskeletal and sports-related specialties

3 Orthobiologic: a biologically derived material used in the regeneration and repair of musculoskeletal tissues. Alshameeri, Z., & McCaskie, A. (2015). The role of orthobiologics in hip preservation surgery. Journal of hip preservation surgery, 2(4), 339.

4 Methods Survey of companies/products – research, development and/ or marketing company websites, press releases & related documents (Jan - June 2015) observations, discussions & materials at exhibitor stands of various sports medicine conferences (in UK, Denmark, Italy and India 2014 – 5)

5 Technology Cell type/ biomaterials Intervention type + purpose No. of Companies No. of Products Injury Autologous Chondrocyte Implantation/ Transplantation (ACI/ ACT) Autologous chondrocytes (+ stem cells, PRP) Surgical - Cartilage regeneration 16 28 Cartilage tears/ degeneration (Knee & ankle) Cartilage allografts Donor chondrocytes (cadaver) 7 Cartilage tears/ defects (Knee) Biological scaffolds Equine - tendon, pericardium Collagen – Porcine, bovine Cadaveric skin cells, amniotic tissue, placental tissue Hyaluronic acid Surgical implants, some used with ACI or microfracture - Cartilage and bone regeneration 12 18 Osteochondral defects Cartilage lesions Wound healing Soft-tissue injuries Donor and synthetic ligaments and tendons Donor ligaments & tendons (cadaver) Bovine collagen Synthetic biomaterials Synthetic materials Surgical – Tissue regeneration 10 Ligament and tendon injuries (e.g. meniscus, ACL, hamstring, patella tendon, Achilles, rotator cuff). Bone grafts and bio-absorbable fixation systems Equine tendon + bone cells Collagen – bovine, porcine Autologous bone cells Bone cells from cadavers + living donors (+ Stem cells, PRP) Surgical - Bone regeneration 22 65 (+) Bone defects, fractures Platelet Rich Plasma (PRP) Platelets + growth factors from autologous blood Injection or adjunct to surgery – Tissue regeneration 23 Tendinopathies, Muscle injuries, Ligament & tendon injuries OA Bone repair Cartilage repair Stem cells Mesenchymal stem cells (MSCs) from Bone marrow aspirate/ concentrate Donor MSCs Haemtopoietic stem cells (HSCs) Injection or adjunct to surgery, combined with other surgical techniques & products - Cartilage and bone regeneration 30 35 Musculoskeletal injuries – general Pain & inflammation

6 Technology Cell type/ biomaterials Intervention type + purpose No. of Companies No. of Products Injury Hyaluronic acid Hyaluronic acid – avian (derived from rooster coxcombs) and non-avian sources Injection (viscosupplementation), combined with other products (e.g. biological scaffolds), adjunct to surgical procedures - To stimulate tissue repair; for pain relief and joint mobility 14 26 OA Chondral and osteochondral lesions Other cell therapy products Tenocytes Autologous blood Autologous adipose Derived Regenerative Cells Placental cells Osteoblasts Osteoprogenitor cells (donor) Gene-therapy Injection, surgical 9 Tendon injuries Muscle injuries Fractures Actovegin Bovine blood Injection, gel or tablet – speeding up tissue regeneration 1 Prolotherapy Dextrose injection – stimulate repair and tissue regeneration Stretched or torn ligaments and tendons Chronic musculoskeletal pain Traumeel Homeopathic injection, tablet, gel – to stimulate tissue regeneration and repair Promote healing and reduce inflammation in the joints Orthobiologics and other regenerative therapeutics on the market/in development (2015): summary table

7 Autologous Chondrocyte Implantation (ACI)
First generation ACI – a two-step procedure. Autologous chondrocytes are harvested, cultured & re-implanted, held in place using a periosteal patch (from shin bone). Second generation ACI – a two-step procedure as above. Autologous chondrocytes held in place using a collagen membrane. Third generation ACI or MACT/MACI– a two-step procedure. Autologous chondrocytes are harvested & cultured within a collagen matrix or scaffold, which is then implanted. IMPACT – a one-step procedure. Autologous chondrocytes are mixed with donor MSCs, the cell mixture is applied to the damaged area during the same operation. AMIC – a one-step procedure that involves microfracture used to obtain MSCs from bone marrow, held in place over the defect by a cell-free scaffold. Some scaffolds incorporate biological factors. ACIC – microfracture with the use of an injectable atelocollagen matrix, performed arthroscopically. MACH – a one step procedure that involves injection of autologous MSCs into the injury site, covered by a PRP enriched collagen membrane. Left, large pan-patellar cartilage defect. Right, ACI cells being injected under a collagen membrane. Image: Mayoclinic.org

8 Biological Scaffolds Surgical implants to promote healing of cartilage or osteochondral defects Made from various biomaterials (e.g. Equine - tendon, pericardium; Collagen – Porcine, bovine; Cadaveric skin cells, amniotic tissue, placental tissue; Hyaluronic acid) Used in the treatment of: Osteochondral defects, cartilage lesions, soft-tissue injuries & wound healing 12 Companies, 18 products

9 Platelet Rich Plasma (PRP)
Platelets & growth factors from autologous blood Injected directly into injury site; sometimes combined with other products/ surgery Range of uses e.g. tendinopathies; muscle/ligament/tendon injuries; OA; bone & cartilage repair, wound healing 18 companies, 23 products

10 Stem Cells Incorporated into different medical devices e.g. seeded into biological membranes or mixed with cartilage cells in ACI. Bone marrow aspirate concentrate (BMAC): aspiration from patient, centrifuged, concentrated & injected back into the patient 30 companies; 35 products Image above: Example of bone marrow aspiration procedure

11 Complementary & Alternative Therapies
Actovegin- made from calf’s blood. Used to speed up recovery times in muscle injuries. Prolotherapy- sugar & water solution. Traumeel- homeopathic remedy. - Used to stimulate the body’s own repair responses & speed up tissue regeneration.

12 Summary 77 companies active in the ‘orthobiologics’ field (orthopaedics market) (2015); 200+ products 27 targeting sports medicine market specifically 29 companies had a UK presence Commercial interest & activity : Bone grafts and bio-absorbable fixation systems – most established market sector (22 companies, 65+ products) Stem cells – 30 companies, 35 products PRP – 18 companies, 23 products Hyaluronic acid – 14 companies, 26 products


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