Badanie fazy IIb oceniające skuteczność intra‑artrykularnego Allocetra-OTS u pacjentów z pierwotną chorobą zwyrodnieniową stawu kolanowego

Knee Osteoarthritis is a condition where the cartilage that cushions the knee joint gradually wears away, leading to pain, stiffness and reduced ability to move. The trial investigates a new medicine named Allocetra-OTS, which contains allogeneic peripheral blood mononuclear cells induced to an early apoptotic state. This product is administered by an intra-articular injection, meaning the solution is directly placed inside the knee joint.

The purpose of the study is to determine whether this treatment improves joint function and lowers pain compared with a placebo. Participants are assigned by chance in a randomized manner and neither the participants nor the investigators know which injection is given, a design called double-blind. Effectiveness is evaluated using the WOMAC questionnaire, a set of questions that rates pain, stiffness and functional ability, as well as a simple daily pain rating called ADP-NRS.

After receiving the injection, participants attend a series of follow‑up visits over several months. During these visits, any side effects, known as adverse events, are recorded, safety laboratory tests are performed, and the questionnaire scores are repeated at 3 and 6 months to track changes. The study concludes after the final follow‑up assessment.