The Safety and Efficacy of XytriX (Umbilical Cord-Derived Mesenchymal Stem Cells) in the Treatment of Knee Osteoarthritis

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for enrollment: Adult patient aged 18 years or older with Grade I-IV knee osteoarthritis as determined by radiographic (X-ray) evaluation. Ambulatory subject with symptoms of knee osteoarthritis for at least 3 months, who may be receiving conservative therapy (e.g., oral anti-inflammatory medication) and/or physical therapy. In subjects with bilateral knee OA, the more symptomatic knee will be designated as the target knee. Subject with joint pain equal to or greater than 7 (out of a total pain score of 24 points) on the target knee as assessed by the WOMAC pain subscale. Subject or legal representative is willing and able to provide written informed consent after reading the informed consent form (ICF) and having the opportunity to discuss the study with the investigator or designee. Women of childbearing potential must have a negative urine pregnancy test prior to treatment administration. Women of childbearing potential and males who are heterosexually active with a female of childbearing potential must agree to use a double barrier method of contraception for at least 4 weeks following administration, unless the female partner is post-menopausal (defined as 12 months of spontaneous amenorrhea, or 6 months amenorrhea with FSH \>40 mIU/mL) or has undergone surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation. Exclusion Criteria: Subjects meeting any of the…