Human Amniotic Suspension Allograft Improves Pain and Function in Knee Osteoarthritis: A Prospective Not Randomized Clinical Pilot Study

Abstract

Osteoarthritis (OA) is a chronic debilitating disorder causing pain and gradual degeneration of joints. Among various cell therapies, mesenchymal stem cell (MSC) therapy appears to provide encouraging results. Human amniotic suspension allografts (HASA) have anti-inflammatory and chondroregenerative potential and represent a promising treatment strategy. The purpose of the present study was to prospectively assess the safety, clinical effectiveness, and feasibility of intra-articular injections of human amniotic suspension allograft (HASA) in unilateral knee OA in order to assess the improvement of symptoms and delay the necessity for invasive surgical procedures. A total of 25 symptomatic patients, affected by knee OA were treated with 3 mL of HASA. Clinical evaluations before the treatment and after 3, 6, and 12 months were performed through International Knee Documentation Committee (IKDC) score and Visual Analogue Scale (VAS) scores. Adverse events were recorded. No severe complications were noted during the treatment and the follow-up period. A statistically significant improvement from basal evaluation to the 3-, 6-, and 12-month follow-up visits was observed. The present pilot study indicates that a single intra-articular injection of HASA seems safe and able to provide positive clinical outcomes, potentially offering a new minimally invasive therapeutic option for patients with knee OA.