Osteoarthritis
Conditions
Interventions
intervention group:Lethal Mesenchymal stem cell injected into the knee
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) be able to sign an informed consent form, follow the research plan, and agree in writing to participate in the research; (2) the age is between 40 and 75 years old, male or female is not restricted. (3) patients diagnosed with knee arthritis (according to the guidelines for the diagnosis and treatment of osteoarthritis of the Orthopaedic Branch of the Chinese Medical Association (2018 Edition) and the diagnostic criteria of knee osteoarthritis established by the American Rheumatic Association in 2012) can be diagnosed if they meet any two of 2, 3, 4, 5); 1 recurrent knee joint pain in the past 1 month. 2X-ray films (standing or weight-bearing position) showed narrowing of joint space, subchondral osteosclerosis and / or cystic degeneration, formation of osteophytes at the edge of the joint, age = 50 years old, morning stiffness time = 30min5, bone friction (sensation) (4) 18 = BMI = 24; (5) Kellgren-Lawrence grade was II-III grade. (6) after more than 3 weeks of physiotherapy (hydrotherapy, cryotherapy, thermotherapy, mud bath therapy, radiofrequency ablation and other percutaneous nerve stimulation therapy, etc.) / drug therapy (glucosamine, diacetate, opioid, hyaluronic acid, etc.) / traditional massage acupuncture did not significantly relieve joint pain and stiffness, and the function of the patients was not significantly improved. Or the symptoms such as pain and stiffness were partially relieved in the short term, but the long-term symptoms still occurred repeatedly. (7) the VAS pain score was more than 4 and lasted at least four months.
Exclusion criteria
Exclusion criteria: (1) Acute inflammatory phase; (2) BMI > 24; (3) joint replacement or arthroscopic surgery; (4) Kellgren-Lawrence2-4 grade IV; (5) diagnosis of rheumatoid arthritis or suspected other pathological conditions of the knee joint; (6) injection of biological agents such as steroids or PRP (concentration of platelet plasma) into the knee joint within 4 weeks. (7) received other treatments in the past year that may affect the observed indicators of treatment of dead mesenchymal stem cells, such as stem cells and other biotherapy, systemic immunosuppressive drugs, etc.; (8) suffering from confirmed infectious diseases such as tuberculosis, HIV, hepatitis and syphilis; (9) complicated with multiple organs and multiple systems underlying diseases; (10) fever of unknown causes within three days > 38.0 ?. (11) history of alcohol and drug abuse; (12) moderate and severe anxiety, depression and other mental diseases; (13) pregnant and lactating women; (14) do not understand Putonghua, do not understand Chinese characters; (15) if you use NSAIDS (non-steroidal anti-inflammatory drugs) or glucosamine or IL-1 receptor antagonists (divinegar, etc.) steadily in the first 4 weeks, there is no need to stop the medication. (16) other situations that the researchers believe may affect the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI of the knee;X-ray of knee joint;WOMAC score;NRS score;routine blood test;biochemical indexes;Urination and defecation routine; | — |
Countries
China
Contacts
Public ContactXuelei Ma
West China Hospital, Sichuan University
Outcome results
None listed