Study Comparing StromaForte Mesenchymal Stem Cells and Hyaluronic Acid for Knee Osteoarthritis Treatment

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte compared to hyaluronic acid for treating knee osteoarthritis. This clinical trial is conducted by Cellcolabs Clinical SPV Limited and aims to assess pain reduction and functional improvement in adults with knee osteoarthritis. The study involves participants with Kellgren-Lawrence grade I to IV osteoarthritis and moderate to severe joint pain. Participants will receive a single dose injection of either StromaForte mesenchymal stem cells or hyaluronic acid as part of two treatment groups. This open-label, non-randomized study compares these two treatments directly without masking. The primary focus is on measuring pain relief at 6 months after injection, with additional follow-up assessments at 3 and 12 months to evaluate pain and functional ability. During the study, participants will undergo assessments including clinical evaluations, pain scoring using the Visual Analogue Scale, and imaging to confirm diagnosis. Researchers will monitor safety and treatment effects for up to one year post-injection. The total study duration includes enrollment, treatment, and follow-up visits to track changes in pain and joint function over time.

An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis