Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis: A Prospective, Single-Center Pilot Study

OBJECTIVE: To evaluate the short-term safety and effectiveness of amniotic membrane/umbilical cord particulate (AMUC) in managing pain in patients with various severities of knee osteoarthritis (OA). DESIGN: Single-center, prospective, investigator-initiated pilot study. SETTING: Private practice. SUBJECTS: A total of 20 knee OA patients aged ≥18 years were enrolled with pain >40 mm, as determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)–A. METHODS: Patients received an ultrasound-guided, intra-articular injection of 50 mg of AMUC particulate reconstituted in 2 mL of preservative-free saline. All patients were then monitored at six weeks, 12 weeks, and 24 weeks postinjection. Patients who did not show >30% reduction in pain received a second injection of AMUC at six weeks. WOMAC, Patient Global Assessment, medication usage, and magnetic resonance imaging (MRI) were assessed. RESULTS: Knee OA pain significantly decreased from 74.3 ± 17.2 at baseline to 45.0 ± 25.4 at six weeks (P < 0.01), 35.4 ± 26.6 at 12 weeks (P < 0.001), and 37.4 ± 26.7 at 24 weeks (P < 0.001). This pain reduction was associated with a significant improvement in physical function (WOMAC-C) at all time points (P < 0.05) and stiffness (WOMAC-B) at 12 weeks (P = 0.01). Eleven patients received a second injection, which was significantly correlated with body mass index >30 kg/m(2) (P = 0.025). MRI evaluation of the overall population revealed an improvement in the severity of bone marrow lesions in seven patients. No adverse events were observed. CONCLUSIONS: AMUC particulate injection relieved pain and improved physical function in patients with symptomatic knee OA.