A Phase III, Randomized, Parallel, Double-blinding, 2-Arm Study to Investigate the Efficacy and Safety of Intra-articular ELIXCYTE (Adipose-Derived Stem Cells) Injection Compared With Placebo in Subjects With Knee Osteoarthritis
This is a Phase III, double-blinded, placebo-controlled, multicenter study to investigate the efficacy and safety of a new study intervention, ELIXCYTE, compared to placebo (normal saline) in subjects with knee osteoarthritis. The primary hypothesis of the study is to demonstrate that ELIXCYTE is superior to placebo (saline) in improving knee pain on the target knee from baseline. During the study, each participant will receive either ELIXCYTE (study intervention) or placebo (normal saline) intra-articular injection once on the target knee after eligibility criteria check. The target knee will be assessed by X-ray, MRI and subject self-evaluation knee questionnaires (WOMAC, KSS and KOOS) in the following visits. Other safety assessments, including lab test, physical examination, vital sign, medical/medication history and adverse events will also be collected throughout the study.
∙ A subject is eligible for the study if all of the following apply:
• Either gender, aged 40 to 80
• With unilateral/bilateral knee OA of Kellgren-Lawrence grading II-III (determined by American College of Rheumatology criteria of knee OA).
• WOMAC pain score of 7 - 17 in the target knee even if treated with chronic doses of NSAID.
• Has received conventional therapies for knee OA (e.g., analgesic administration or physical therapy) for more than 3 months but the symptoms have not relieved.
• Unwilling or not suitable to undergo knee surgery (including total knee replacement and knee arthroplasty).
• Understands and has signed the informed consent form.
• With adequate hematological indices:
‣ White blood cell (WBC) ≥ 3,000/mm3
⁃ Platelet count ≥ 80,000/μL
• With adequate coagulation indices: Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of the normal range (ULN).
• With adequate liver function where serum total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase (AST) ≤ 3 times ULN, and alanine aminotransferase (ALT) ≤ 3 times ULN.
⁃ Has an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.