Phase IIb Open Label Study Evaluating Safety and Tolerability of OA-SYS Treatment for Moderate to Severe Knee Osteoarthritis in Adults Aged 35 to 75

What this Trial Is About

Researchers are evaluating the safety and tolerability of OA-SYS, a treatment for moderate to severe osteoarthritis OA of the knee joint. OA is a common condition that causes joint pain and disability, particularly in older adults. This phase II open-label clinical trial aims to determine if OA-SYS, which uses adult stem cells derived from fat tissue, is a safe and potentially helpful option for people suffering from knee OA. Participants will receive the OA-SYS treatment through administration of adult stem cells directly into the knee joint. This study does not use a placebo or blinding, and participants will attend regular clinic visits for monitoring. Throughout the study, participants will report any side effects or changes in their knee condition to help researchers understand the treatments safety and tolerability. During their participation, individuals will undergo evaluations including physical exams, vital sign checks, and laboratory tests. Researchers will monitor adverse events over 52 weeks and assess changes in pain levels and knee function using tools like the Western Ontario and McMaster Universities Arthritis Index WOMAC and Visual Analog Scale VAS. Participants will be followed for a year to closely observe the treatments effects and safety.

An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint