Frontiers in Safety and Efficacy: Introduction
Main Article Content
Keywords
musculoskeletal, cost, aging population, orthobiologic therapies
Abstract
There are increasing numbers of people suffering with osteoarthritis and other musculoskeletal disorders. Current treatments for these conditions have significant side effects and comorbidities. Surgery in some cases may be inappropriate or ineffective. The use of regenerative medicine in the form of orthobiologics has been growing. The purpose of these treatments is to treat pain and to possibly enhance the healing of tissue pathology by augmenting the body’s inherent healing capabilities. Orthobiologic products commonly used include platelet rich plasma, adipose and bone marrow derived cellular products and birth tissue products. This review of the current medical literature has been prepared to provide evidence-based information to patients, clinicians, researchers, and regulatory and payer organizations with regard to the safety, efficacy, and cost effectiveness of orthobiologic treatments.
References
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13. Malanga G and Goldin M. PRP: review of the current evidence for musculoskeletal conditions. Curr Phys Med Rehab Rep 2014;2(1):1-15.
14. Tang C, Chen Y, Huang J, et al. The roles of inflammatory mediators and immunocytes in tendinopathy. J Orthopaed Transl 2018;14:23-33.
15. Coombes BK, Bisset L, and Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. The Lancet 2010;376(9754):1751-1767.
16. Coombes BK, Bisset L, Brooks P, et al. Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: a randomized controlled trial. JAMA 2013;309(5):461-469.
17. Puzzitiello RN, Patel BH, Forlenza EM, et al. Adverse impact of corticosteroids on rotator cuff tendon health and repair: a systematic review of basic science studies. Arthroscop Sports Med Rehabil 2020;2(2):e161-e169.
18. Zeng C, Lane N, Hunter D, et al. Intra-articular corticosteroids and the risk of knee osteoarthritis progression: results from the Osteoarthritis Initiative. Osteoarthritis and Cartilage 2019; 27(6), 855-862.
19. Lohmander LS and Roos EM. The evidence base for orthopaedics and sports medicine: scandalously poor in parts. Br J Sports Med 2016;50(9):564-565.
20. Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med 2013;369:2515-2524.
21. Paavola M, Malmivaara A, Taimela S, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo-controlled clinical trial. BMJ 2018;362.
22. Schrøder CP, Skare Ø, Reikerås O, et al. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med 2017;51(24):1759-1766.
23. Erggelet C and Vavken P. Microfracture for the treatment of cartilage defects in the knee joint–A golden standard? J Clin Orthopaed Trauma 2016;7(3):145-152.
24. Gudas R, Kalesinskas RJ, Kimtys V, et al. A prospective randomized clinical study of mosaic osteochondral autologous transplantation versus microfracture for the treatment of osteochondral defects in the knee joint in young athletes. Arthroscopy: J Arthroscop Related Surg 2005;21(9):1066-1075.
25. Koes BW, Scholten RJ, Mens JM. and Bouter LM. Efficacy of epidural steroid injections for low-back pain and sciatica: a systematic review of randomized clinical trials. Pain 1995;63(3):279-288.
26. Bogduk N and Andersson G. Is spinal surgery effective for back pain? F1000 Medicine Reports 2009;1.
27. Al-Shoha A, Rao DS, Schilling J, et al. Effect of epidural steroid injection on bone mineral density and markers of bone turnover in postmenopausal women. Spine 2012;37(25):E1567-E1571.
28. Mandel S, Schilling J, Peterson E, Rao DS, Sander W. J Bone Joint Surg Am 2013 Jun 5;95(11):961-4.
29. Sytsma TT, Greenlund LK, and Greenlund LS. Joint corticosteroid injection associated with increased influenza risk. Mayo Clinic Proceedings: Innovat Qual Outcome 2018;2(2):194-198.
30. Cato RK. Indications and usefulness of common injections for nontraumatic orthopedic complaints. Medical Clinics 2016;100(5):1077-1088.
31. McAlindon TE, LaValley MP, Harvey WF, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis: a randomized clinical trial. JAMA 2017;317(19), 1967-1975.
32. Rong AJ, Lam BL, Ansari ZA, Albini TA. Vision Loss Secondary to Autologous Adipose Stem Cell Injections: A Rising Problem. JAMA Ophthalmol 2018 Jan 1;136(1):97-99.
33. Kuriyan AE, Albini TA, Townsend JH, et al. Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD. N Engl J Med. 2017 Mar 16;376(11):1047-1053.
34. Amariglio N, Hirshberg A, Scheithauer BW, et al. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med 2009;6(2), e1000029.
35. Dlouhy BJ, Awe O, Rao RC, Kirby PA, Hitchon PW. Autograft-derived spinal cord mass following olfactory mucosal cell transplantation in a spinal cord injury patient: Case report. J Neurosurg Spine. 2014 Oct;21(4):618-22.
36. Centeno CJ, Al-Sayegh H, Freeman MD, et al. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Internat Orthopaed 2016;40:1755-1765.
37. Perkins KM, Spoto S, Rankin DA, et al. Infections after receipt of bacterially contaminated umbilical cord blood–derived stem cell products for other than hematopoietic or immunologic reconstitution—United States, 2018. Morbid Mortal Weekly Rep 2018;67(50):1397-1399.
38. Marenah M, Li J, Kumar A, Murrell W. Quality assurance and adverse event management in regenerative medicine for knee osteoarthritis: Current concepts. J Clin Orthopaed Trauma 2019;10(1), 53-58.
39. Pittenger M, Discher D. Pérault BM, et al. Mesenchymal stem cell perspective: cell biology to clinical progress. NPJ Regenerat Med 2019;4:22.
40. Rodeo S. Stem Cells 101. Am J Sports Med 2021;49(6):1417-1420. doi:10.1177/03635465211011082
41. Horwitz EM, Le Blanc K, Dominici M, et al. Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy 2005;7(5):393-395. https://doi.org/10.1080/14653240500319234
42. Caplan AI. Mesenchymal stem cells: time to change the name! Stem Cells Translational Med 2017;6(6):1445-1451.
2. Yu S and Zuckerman J. 5 Points on Orthopedics in US Health Care. Am J Orthop 2015;44:12.
3. Hartman M, Martin AB, Espinosa N, et al. National health care spending in 2016: spending and enrollment growth slow after initial coverage expansions. Health Affairs 2018;37(1):150-160.
4. Cutler DM, and Ghosh K. The potential for cost savings through bundled episode payments. New Engl J Med 2012;366(12):1075.
5. Vina ER and Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol 2018;30(2):160.
6. Hsu H and Siwiec R. Knee Osteoarthritis.[Updated 2019 Jun 17]. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019.
7. Vaishya R, Pariyo GB, Agarwal AK, and Vijay V. Non-operative management of osteoarthritis of the knee joint. J Clin Orthop Trauma 2016;7(3):170-176. https://doi.org/10.1016/j.jcot.2016.05.005
8. Miller LE, Fredericson M, Altman RD. Hyaluronic acid injections or oral nonsteroidal anti-inflammatory drugs for knee osteoarthritis: systematic review and meta-analysis of randomized trials. Orthop J Sports Med. 2020 Jan 27;8(1):2325967119897909. doi: 10.1177/2325967119897909.
9. Kon E, Filardo G, Drobnic M, Madry H, Jelic M, van Dijk N, Della Villa S. Non-surgical management of early knee osteoarthritis. Knee Surg Sports Traumatol Arthroscop 2012 Mar;20:436-49.
10. Parker DA, Scholes C, Neri T. Non-operative treatment options for knee osteoarthritis: current concepts. Journal of ISAKOS. 2018 Sep 1;3(5):274-81.
11. London NJ, Miller LE, and Block JE. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Med Hypotheses 2011;76(6):887-892. https://doi.org/10.1016/j.mehy.2011.02.044
12. Malanga G and Nakamura R. The role of regenerative medicine in the treatment of sports injuries. Phys Med Rehabil Clin 2014;25(4):881-895.
13. Malanga G and Goldin M. PRP: review of the current evidence for musculoskeletal conditions. Curr Phys Med Rehab Rep 2014;2(1):1-15.
14. Tang C, Chen Y, Huang J, et al. The roles of inflammatory mediators and immunocytes in tendinopathy. J Orthopaed Transl 2018;14:23-33.
15. Coombes BK, Bisset L, and Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. The Lancet 2010;376(9754):1751-1767.
16. Coombes BK, Bisset L, Brooks P, et al. Effect of corticosteroid injection, physiotherapy, or both on clinical outcomes in patients with unilateral lateral epicondylalgia: a randomized controlled trial. JAMA 2013;309(5):461-469.
17. Puzzitiello RN, Patel BH, Forlenza EM, et al. Adverse impact of corticosteroids on rotator cuff tendon health and repair: a systematic review of basic science studies. Arthroscop Sports Med Rehabil 2020;2(2):e161-e169.
18. Zeng C, Lane N, Hunter D, et al. Intra-articular corticosteroids and the risk of knee osteoarthritis progression: results from the Osteoarthritis Initiative. Osteoarthritis and Cartilage 2019; 27(6), 855-862.
19. Lohmander LS and Roos EM. The evidence base for orthopaedics and sports medicine: scandalously poor in parts. Br J Sports Med 2016;50(9):564-565.
20. Sihvonen R, Paavola M, Malmivaara A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med 2013;369:2515-2524.
21. Paavola M, Malmivaara A, Taimela S, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo-controlled clinical trial. BMJ 2018;362.
22. Schrøder CP, Skare Ø, Reikerås O, et al. Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med 2017;51(24):1759-1766.
23. Erggelet C and Vavken P. Microfracture for the treatment of cartilage defects in the knee joint–A golden standard? J Clin Orthopaed Trauma 2016;7(3):145-152.
24. Gudas R, Kalesinskas RJ, Kimtys V, et al. A prospective randomized clinical study of mosaic osteochondral autologous transplantation versus microfracture for the treatment of osteochondral defects in the knee joint in young athletes. Arthroscopy: J Arthroscop Related Surg 2005;21(9):1066-1075.
25. Koes BW, Scholten RJ, Mens JM. and Bouter LM. Efficacy of epidural steroid injections for low-back pain and sciatica: a systematic review of randomized clinical trials. Pain 1995;63(3):279-288.
26. Bogduk N and Andersson G. Is spinal surgery effective for back pain? F1000 Medicine Reports 2009;1.
27. Al-Shoha A, Rao DS, Schilling J, et al. Effect of epidural steroid injection on bone mineral density and markers of bone turnover in postmenopausal women. Spine 2012;37(25):E1567-E1571.
28. Mandel S, Schilling J, Peterson E, Rao DS, Sander W. J Bone Joint Surg Am 2013 Jun 5;95(11):961-4.
29. Sytsma TT, Greenlund LK, and Greenlund LS. Joint corticosteroid injection associated with increased influenza risk. Mayo Clinic Proceedings: Innovat Qual Outcome 2018;2(2):194-198.
30. Cato RK. Indications and usefulness of common injections for nontraumatic orthopedic complaints. Medical Clinics 2016;100(5):1077-1088.
31. McAlindon TE, LaValley MP, Harvey WF, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis: a randomized clinical trial. JAMA 2017;317(19), 1967-1975.
32. Rong AJ, Lam BL, Ansari ZA, Albini TA. Vision Loss Secondary to Autologous Adipose Stem Cell Injections: A Rising Problem. JAMA Ophthalmol 2018 Jan 1;136(1):97-99.
33. Kuriyan AE, Albini TA, Townsend JH, et al. Vision Loss after Intravitreal Injection of Autologous “Stem Cells” for AMD. N Engl J Med. 2017 Mar 16;376(11):1047-1053.
34. Amariglio N, Hirshberg A, Scheithauer BW, et al. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med 2009;6(2), e1000029.
35. Dlouhy BJ, Awe O, Rao RC, Kirby PA, Hitchon PW. Autograft-derived spinal cord mass following olfactory mucosal cell transplantation in a spinal cord injury patient: Case report. J Neurosurg Spine. 2014 Oct;21(4):618-22.
36. Centeno CJ, Al-Sayegh H, Freeman MD, et al. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Internat Orthopaed 2016;40:1755-1765.
37. Perkins KM, Spoto S, Rankin DA, et al. Infections after receipt of bacterially contaminated umbilical cord blood–derived stem cell products for other than hematopoietic or immunologic reconstitution—United States, 2018. Morbid Mortal Weekly Rep 2018;67(50):1397-1399.
38. Marenah M, Li J, Kumar A, Murrell W. Quality assurance and adverse event management in regenerative medicine for knee osteoarthritis: Current concepts. J Clin Orthopaed Trauma 2019;10(1), 53-58.
39. Pittenger M, Discher D. Pérault BM, et al. Mesenchymal stem cell perspective: cell biology to clinical progress. NPJ Regenerat Med 2019;4:22.
40. Rodeo S. Stem Cells 101. Am J Sports Med 2021;49(6):1417-1420. doi:10.1177/03635465211011082
41. Horwitz EM, Le Blanc K, Dominici M, et al. Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy 2005;7(5):393-395. https://doi.org/10.1080/14653240500319234
42. Caplan AI. Mesenchymal stem cells: time to change the name! Stem Cells Translational Med 2017;6(6):1445-1451.
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Published
Oct 15, 2024
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How to Cite
Roman, S. J., Rodeo, S., & Murrell, W. D. (2024). Frontiers in Safety and Efficacy: Introduction. Biologic Orthopedics Journal, 6(SP1), 1–6. https://doi.org/10.22374/boj.v6iSP1.62
Section
Special Issue: Frontiers in Safety and Efficacy
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