Single Center, Open-label, Dose-increasing Phase I Clinical Trial of UC-MSCs for the Treatment of Knee Osteoarthritis
In recent years, the incidence rate and disability rate of osteoarthritis have continued to grow, and it has become a common chronic disease of elderly patients, second only to the three highs, and poses a continuous threat to China's medical and health system and public health system. Knee osteoarthritis is the main type of osteoarthritis, ranking 11th in global disability diseases and 38th in disability adjusted life year loss, causing significant economic burden to patients, families, and society. At present, most of the treatment methods for KOA have limited efficacy, only relieving pain symptoms and cannot prevent cartilage damage and other tissue damage in the joints. Due to the limitations of adverse events, there is still no optimal treatment plan for KOA. Most studies believe that autologous mesenchymal stem cell transplantation is a new treatment method with good efficacy and good repair effect for mild to moderate cartilage defects. Given that there is currently no optimal treatment plan for KOA, human umbilical cord mesenchymal stem cell injection has potential development value and is of great significance for the treatment of KOA patients.
• Prior to conducting any assessment, written informed consent must be obtained;
• Able to communicate well with researchers during screening, understand and comply with experimental requirements;
• Age range from 50 to 70 years old (including threshold), regardless of gender;
• Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18-26 kg/m2 (including critical values);
• According to the diagnostic criteria for knee osteoarthritis in the Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition), subjects diagnosed with knee osteoarthritis (see Annex 1 for details); The course of knee osteoarthritis is more than 4 weeks;
• The target knee joint X-ray Kellgren Lawrence radiological grading (K-L IV grade) is II-III grade. Patients diagnosed with knee osteoarthritis on both sides should have non target knee joint symptoms, signs, and grading that do not exceed the target knee joint;
• MRI examination shows partial or full layer damage to the cartilage of the knee joint;
• A VAS score of ≥ 5 and ≤ 7 for knee joint pain at least 48 hours after discontinuing the use of all painkillers during screening;
• Patients who use analgesic therapy (taking paracetamol/acetaminophen) to control local pain in the target knee joint agree to discontinue the use of similar analgesics 2 weeks prior to administration, and only allow NSAID as a rescue drug; Patients who use glucosamine, chondroitin, opioid drugs, or diacetate, glucosamine, etc. must agree to discontinue such drugs from 2 weeks prior to administration.