J Knee Surg 2021; 34(08): 841-845
DOI: 10.1055/s-0039-3400951
Original Article

Micronized Dehydrated Human Amnion Chorion Membrane Injection in the Treatment of Knee Osteoarthritis—A Large Retrospective Case Series

Kris J. Alden
1   Department of Surgery, Hinsdale Orthopaedics Associates, Hinsdale, Illinois
,
Stan Harris
2   Department of Medical Affairs, MiMedx Group Inc., Marietta, Georgia
,
Brandon Hubbs
2   Department of Medical Affairs, MiMedx Group Inc., Marietta, Georgia
,
Kimberly Kot
2   Department of Medical Affairs, MiMedx Group Inc., Marietta, Georgia
,
Niki B. Istwan
2   Department of Medical Affairs, MiMedx Group Inc., Marietta, Georgia
,
David Mason
2   Department of Medical Affairs, MiMedx Group Inc., Marietta, Georgia
› Author Affiliations

Abstract

Osteoarthritis (OA) of the knee is a leading cause of chronic pain and disability in the United States. Current treatment options primarily target OA symptoms reserving surgical intervention and knee replacement for those who fail conservative measures. With average age of patients with knee OA decreasing, regenerative treatment approaches to reduce symptoms, increase quality of life, and delay the need for surgical intervention are increasingly sought. Human amniotic membrane contains growth factors and cytokines, which promote epithelial cell migration and proliferation, stimulate metabolic processes leading to collagen synthesis, and attract fibroblasts, while also reducing pain and inflammation. Micronization of the tissue allows for suspension in normal saline and injection. We conducted a retrospective review of 100 knees treated for symptomatic OA with micronized dehydrated human amnion/chorion membrane (mdHACM) and followed for 6 months. Our purpose is to present our experience and patient outcomes. Data were abstracted from electronic medical records of 82 consecutive OA patients (100 knees) injected with 100 mg mdHACM. Patient age, gender, adverse events and routinely collected Knee Injury and Osteoarthritis Outcome Score (KOOS) were evaluated. Effectiveness of mdHACM treatment was measured by serial KOOS at baseline, and posttreatment at 6 weeks, 3, and 6 months. Overall mean KOOS for the cohort was 40 at baseline, improving to 52, 62, and 65 at 6 weeks, 3 months, and 6 months post-mdHACM injection. Percent increases were 32, 56, and 65%, respectively. Quality of life and sports/recreation domains improved by 111 and 118%, respectively, at 6 months. Pain scores improved by 67% at 6 months. All scores improved throughout the observation period. The most common adverse event was pain after injection lasting 2 to 7 days, observed in 68% of cases. This represents the largest single-physician experience with mdHACM for treatment of knee OA reported to date. Injectable mdHACM appears to be a potentially useful treatment option for knee OA patients. Controlled studies are underway to confirm these observations.



Publication History

Received: 05 September 2019

Accepted: 14 October 2019

Article published online:
28 November 2019

© 2019. Thieme. All rights reserved.

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

 
  • References

  • 1 Statistics A-R. Centers for Disease Control and Prevention website. Accessed May 22, 2018 at: https://www.cdc.gov/arthritis/data_statistics/arthritis-related-stats.htm
  • 2 Guccione AA, Felson DT, Anderson JJ. et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. Am J Public Health 1994; 84 (03) 351-358
  • 3 Barbour KE, Helmick CG, Boring M, Brady TJ. Vital signs: prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation - United States, 2013-2015. MMWR Morb Mortal Wkly Rep 2017; 66 (09) 246-253
  • 4 Cutler DM, Ghosh K. The potential for cost savings through bundled episode payments. N Engl J Med 2012; 366 (12) 1075-1077
  • 5 Cross M, Smith E, Hoy D. et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis 2014; 73 (07) 1323-1330
  • 6 Oo WM, Yu SP-C, Daniel MS, Hunter DJ. Disease-modifying drugs in osteoarthritis: current understanding and future therapeutics. Expert Opin Emerg Drugs 2018; 23 (04) 331-347
  • 7 Martel-Pelletier J, Wildi LM, Pelletier JP. Future therapeutics for osteoarthritis. Bone 2012; 51 (02) 297-311
  • 8 Hannon CP, Yanke AB, Farr J. Amniotic tissue modulation of knee pain-a focus on osteoarthritis. J Knee Surg 2019; 32 (01) 26-36
  • 9 Lei J, Priddy LB, Lim JJ, Massee M, Koob TJ. Identification of extracellular matrix components and biological factors in micronized dehydrated human amnion/chorion membrane. Adv Wound Care (New Rochelle) 2017; 6 (02) 43-53
  • 10 Lei J, Priddy LB, Lim JJ, Koob TJ. Dehydrated human amnion/chorion membrane (dHACM) allografts as a therapy for orthopedic tissue repair. Tech Orthop 2017; 32 (03) 149-157
  • 11 Willett NJ, Thote T, Lin AS. et al. Intra-articular injection of micronized dehydrated human amnion/chorion membrane attenuates osteoarthritis development. Arthritis Res Ther 2014; 16 (01) R47
  • 12 Raines AL, Shih M-S, Chua L, Su C-W, Tseng SC, O'Connell J. Efficacy of particulate amniotic membrane and umbilical cord tissues in attenuating cartilage destruction in an osteoarthritis model. Tissue Eng Part A 2017; 23 (1-2): 12-19
  • 13 Marino-Martínez IA, Martínez-Castro AG, Peña-Martínez VM. et al. Human amniotic membrane intra-articular injection prevents cartilage damage in an osteoarthritis model. Exp Ther Med 2019; 17 (01) 11-16
  • 14 Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved amniotic suspension for the treatment of knee osteoarthritis. J Knee Surg 2016; 29 (06) 443-450
  • 15 Sclafani JA, Liang K, Mosley D, Prevost M. A retrospective chart assessment of clinical outcomes after amniotic suspension allograft is used during spinal arthrodesis procedures. Surg Sci 2016; 07 (03) 150-156
  • 16 Nunley PD, Kerr III EJ, Utter PA. et al. Preliminary results of bioactive amniotic suspension with allograft for achieving one and two-level lumbar interbody fusion. Int J Spine Surg 2016; 10: 12
  • 17 Anderson JJ, Swayzee Z. The use of human amniotic allograft on osteochondritis dissecans of the talar dome: a comparison with and without allografts in arthroscopically treated ankles. Surg Sci 2015; 06 (09) 412-417
  • 18 Werber B. Amniotic tissues for the treatment of chronic plantar fasciosis and Achilles tendinosis. J Sports Med (Hindawi Publ Corp) 2015; 2015 (01) 219896
  • 19 Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Foot Ankle Int 2013; 34 (10) 1332-1339
  • 20 Hanselman AE, Tidwell JE, Santrock RD. Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study. Foot Ankle Int 2015; 36 (02) 151-158
  • 21 Gellhorn AC, Han A. The use of dehydrated human amnion/chorion membrane allograft injection for the treatment of tendinopathy or arthritis: a case series involving 40 patients. PM R 2017; 9 (12) 1236-1243
  • 22 Cazzell S, Stewart J, Agnew PS. et al. Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis. Foot Ankle Int 2018; 39 (10) 1151-1161
  • 23 Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 2003; 1: 64 Review
  • 24 Xie F, Kovic B, Jin X, He X, Wang M, Silvestre C. Economic and humanistic burden of osteoarthritis: a systematic review of large sample studies. Pharmacoeconomics 2016; 34 (11) 1087-1100
  • 25 Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol 2014; 10 (07) 437-441
  • 26 Charlesworth J, Fitzpatrick J, Perera NKP, Orchard J. Osteoarthritis- a systematic review of long-term safety implications for osteoarthritis of the knee. BMC Musculoskelet Disord 2019; 20 (01) 151
  • 27 Levy DM, Petersen KA, Scalley Vaught M, Christian DR, Cole BJ. Injections for knee osteoarthritis: corticosteroids, viscosupplementation, platelet-rich plasma, and autologous stem cells. Arthroscopy 2018; 34 (05) 1730-1743