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

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.

Human amniotic membrane modulates Wnt/β-catenin and NF-κβ signaling pathways in articular chondrocytes in vitro

“…Despite little evidence to support matrix regeneration, these results indicate the potential for imparting a chondroprotective effect and attenuating degeneration in vitro . This study substantiates previous clinical [ [4] , [5] , [6] ] and pre-clinical evidence suggesting μdHACM treatment improves the outcomes associated with OA. Specifically, μdHACM attenuated the onset of surgically-induced OA in a medial meniscal transection (MMT) rat model [ 3 ].…”

“…Micronized dehydrated human amnion/chorion membrane (μdHACM; MiMedx Group, Inc.), an injectable advanced biologic, is explored as an alternative solution to the shortcomings of traditional treatments. Previously published animal studies [ 3 ] and early outcomes in clinical studies [ [4] , [5] , [6] ] have demonstrated success using μdHACM for OA, notably resulting in symptomatic improvements and pain reduction; however, the molecular mechanisms by which this is accomplished is unknown. μdHACM is a PURION® processed allograft, which retains regulatory proteins inherent to native amniotic tissues.…”

Intra-articular delivery of micronized dehydrated human amnion/chorion membrane reduces degenerative changes after onset of post-traumatic osteoarthritis

“…Several clinical case series have recently been published in support of the use of particulate amniotic membrane ECM-based materials (amnion, chorion, umbilical cord, amniotic fluid) to treat OA ( Mead and Mead, 2020 ; Natali et al, 2022 ; Alden et al, 2021 ; Bennett, 2019 ; Castellanos and Tighe, 2019 ; Farr et al, 2019 ; Vines et al, 2016 ). Four of the studies specifically addressed knee OA, though they were relatively small preliminary studies (6, 20, 25, and 42 qualifying patients), and indicated that single injections with suspensions of either amniotic membrane, amniotic membrane combined with umbilical cord, or amniotic membrane combined with amniotic fluid may help reduce knee pain and improve function in moderate knee OA in the short term ( Mead and Mead, 2020 ; Natali et al, 2022 ; Castellanos and Tighe, 2019 ; Vines et al, 2016 ).…”

“…One large retrospective case series has been published on the use of injectable micronized dehydrated human amnion/chorion membrane (dHACM) alone, and it included review of 100 knees treated with the product. Patient-reported outcome scores (including pain, daily living, sports/recreation, and quality of life categories increased over time up to 6 months ( Alden et al, 2021 ). One multi-center level I randomized controlled trial that enrolled 200 knee OA patients concluded that treatment with single injection of an amniotic membrane particulate/amniotic fluid suspension was superior to hyaluronic acid and saline at 3 and 6 months in terms of pain relief and improved function.…”

Intra-Articular Laser Therapy May Be a Feasible Option in Treating Knee Osteoarthritis in Elderly Patients

“…For patients who are taking antiplatelet and anticoagulation medications, they may not be able to receive autologous platelet-rich plasma (PRP) injections [ 6 ]. Other treatment options include the application of physical modalities, the wearing of insoles, and the injection of other injectants such as micronized dehydrated human amnion/chorion membrane (mdHACM) [ 8 , 9 ]. Researchers are continuously searching for nonsurgical disease-modifying options for the treatments of knee OA [ 10 ].…”