Study of Amniotic Suspension Allograft Injections Compared to Hyaluronic Acid and Saline for Treating Knee Osteoarthritis in Adults

What this Trial Is About

Researchers are evaluating the effects of amniotic suspension allograft ASA injections compared to hyaluronic acid HA and saline injections for treating knee osteoarthritis in adults aged 18 to 80. This condition involves joint cartilage damage and inflammation leading to pain and decreased mobility. The study aims to find the best ASA dose and assess its potential to reduce inflammation and improve quality of life compared to existing injection treatments. Participants will be randomly assigned to receive one of four intra-articular knee injections under ultrasound guidance ASA 40 mg, ASA 20 mg, HA, or saline. ASA injections are prepared by diluting AMNIOGEN tissue in saline, while HA and saline are administered as per standard concentrations. The trial is double-blind, ensuring neither participants nor researchers know the assigned treatment. Injections and follow-up occur over a 12-month period. During the study, participants will undergo assessments including pain scales VAS, NRS, knee injury and osteoarthritis outcome scores KOOS, and quality of life evaluations WHOQOL-BREF. Laboratory tests such as complete blood count, C-reactive protein, erythrocyte sedimentation rate, and cytokine levels will be monitored. Imaging with knee ultrasound and X-ray will assess joint status, alongside cartilage protein measurements. Safety and treatment effects will be observed throughout the 12 months of follow-up.

Amniotic Suspension Allograft Injection for Knee Osteoarthritis