Micronized Dehydrated Human Amnion/Chorion Membrane Injection in the Treatment of Chronic Achilles Tendinitis.

Background: Human amniotic membrane contains growth factors and cytokines that promote epithelial cell migration and proliferation, stimulate metabolic processes that lead to collagen synthesis, and attract fibroblasts, while also reducing pain and inflammation. Randomized studies have shown effectiveness of micronized dehydrated human amnion/chorion membrane (mdHACM) allograft injection in treatment of plantar fasciitis. We present our experience and short-term outcomes with using mdHACM injection as a treatment for Achilles tendinopathy. Methods: Retrospective case series of patients with Achilles tendinopathy treated with mdHACM by a single physician. Participants had at least two follow-up visits within 45 days of mdHACM injection. Outcomes examined included change in reported level of pain during the 45-day observation period and treatment-associated adverse events. Results: Follow-up data were available for 32 mdHACM-treated patients. At treatment initiation, 97% of patients reported severe (66%) or moderate (31%) pain. At the first follow-up visit (mean ± SD of 8.1 ± 2.7 days postinjection), 27 patients (84%) reported improvement in pain levels, although 37% of patients continued to report severe (6%) or moderate (31%) pain. At the second follow-up visit (mean ± SD of 23.1 ± 6.2 days postinjection), no patients reported severe pain and one reported moderate pain. Within 45 days of mdHACM injection, complete symptom resolution was reported by 66% of treated patients (n = 21), with the remaining 34% (n = 11) reporting symptom improvement but not complete resolution. Two patients reported calf or quadricep pain or tightness after injection. Conclusions: In our experience, mdHACM injection reduced or eliminated pain in all 32 patients with follow-up data.

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

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.

Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft.

Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention-to-treat (ITT) and/or the per-protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias. A previous report from an RCT conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane allograft (EpiFix) as an adjunct to standard comprehensive wound therapy consisting of moist dressings and multi-layer compression in the healing of venous leg ulcers (VLUs) only reported PP study results (n = 109, 52 EpiFix and 57 standard care patients), although there were 128 patients randomised: 64 to the EpiFix group and 64 to the standard care group. Primary study outcome was the incidence of healing at 12 weeks. The purpose of the present study is to report ITT results on all 128 randomised subjects and assess if both ITT and PP data analyses arrive at the same conclusion of the efficacy of EpiFix as a treatment for VLU. Rates of healing for the ITT and PP populations were, respectively, 50% and 60% for those receiving EpiFix and 31% and 35% for those in the standard care cohort. Within both ITT and PP analyses, these differences were statistically significant; P = 0.0473, ITT and P = 0.0128, PP. The Kaplan-Meier plot of time to heal within 12 weeks for the ITT and PP populations demonstrated a superior wound-healing trajectory for EpiFix compared with VLUs treated with standard care alone. These data provide clinicians and health policymakers an additional level of assurance regarding the effectiveness of EpiFix.