Allogenic Adipose-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT06570291
- Lead Sponsor
- Wuxi Cellular Biopharmaceutical Group Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 488
Inclusion Criteria:<br><br> 1. Subjects who understand and voluntarily sign the consent form before this study;<br><br> 2. According to the diagnostic criteria (American Rheumatology Association, clinical +<br> radiology criteria), patients with knee osteoarthritis are definitely diagnosed;<br><br> 3. Age: 40-75, males and females;<br><br> 4. The course of knee osteoarthritis was more than 6 months;<br><br> 5. The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the -WOMAC<br> score at least 48 hours after discontinuation of all painkillers);<br><br> 6. The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was<br> grade II / III;<br><br> 7. Subjects are generally in good condition and can walk autonomously, except for those<br> who use wheelchairs, walking aids or crutches.<br><br>Exclusion Criteria:<br><br> 1. The subject may be allergic to the main cell preparation components (B vitamins,<br> amino acids and so on).<br><br> 2. The subject received systemic and / or local treatment with autologous and / or<br> allogeneic mesenchymal progenitor cells.<br><br> 3. The subject has a BMI of over 30.<br><br> 4. Laboratory test (any item meets): neutrophil absolute number < 1.0 × 10^9 / L,<br> platelet count < 50 × 10^9 / L, serum albumin < 30g / L, serum creatinine > upper<br> limit of 1.2 times normal value range, total bilirubin?alanine<br> aminotransferase?aspartate aminotransferase > upper limit of 2 times of normal value<br> range.<br><br> 5. The subject has diseases or symptoms may affect VAS, WOMAC and so on.<br><br> 6. The subject has serious and poorly controlled concomitant diseases, such as (but not<br> limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and<br> endocrine diseases, which may prevent the subjects from participating in the study<br> according to the judgment of the researchers.<br><br> 7. The subject has an history malignant tumour.<br><br> 8. The subject has connective tissue disease or rheumatoid<br> arthritis?chondropathy?Chondrocalcinosis articularis? Hemochromatosis?inflammatory<br> arthropathy?avascular necrosis of femoral head?Paget's disease?hemophilic<br> arthropathy?infectional arthritis?Charcot' s disease?villonodular synovitis or<br> synovial chondromatosis.<br><br> 9. The subject has severe generalized infectious diseases or local knee infection<br> (including skin and intra-articular infection) in the 3 months prior to this trial.<br><br> 10. According to the researchers, the subject has disease of lower limbs which may be<br> interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc<br> protrusion and so on.<br><br> 11. The subject had any other coagulation dysfunction caused by acute or chronic<br> diseases, according to the judgment of the researchers, this coagulation dysfunction<br> may endanger the safety of patients and / or affect the judgment of knee joint<br> evaluation indicators.<br><br> 12. The subject has received arthroscopic surgery or other open surgery related to knee<br> joint operation in the 6 months prior to this trial.<br><br> 13. The subject has received other intra-articular injections, including but not limited<br> to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic<br> glucose and so on for KOA in the 3 months preceding the trial.<br><br> 14. The subject has received aminoglucose or chondroitin sulfate within 1 month before<br> the treatment.<br><br> 15. The subject has used dexamethasone, prednisone, hydrocortisone and other hormones<br> orally / intravenously within 1 month before the treatment.<br><br> 16. The subject has attenuated or live attenuated vaccine injection with 1 month before<br> the treatment.<br><br> 17. The subject has undergone knee prosthesis or a plan of knee prosthesis within the<br> trial.<br><br> 18. The subject has contraindication of MRI, included but not only: the subject<br> installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis,<br> metal clip after aneurysm surgery, drug infusion device implanted in vivo, any<br> electronic device implanted in the body (nerve stimulator, bone growth stimulator)<br> endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body,<br> plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear<br> shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia,<br> critical ill patient and so on.<br><br> 19. The subject tests positive for: HIV, HBV, HCV and treponema pallidum.<br><br> 20. The subject has history of alcoholism, drug abuse, or mental illness in the 3 years<br> prior to this trial.<br><br> 21. The subject has participated in any other clinical trial in the 3 months prior to<br> this trial.<br><br> 22. The subject (including male subjects) has fertility, sperm donation or egg donation<br> plans during the trial period; the female subject is pregnant, lactating or having a<br> positive pregnancy test.<br><br> 23. The subject is legally disabled by reference to the law of the people's Republic of<br> China on the protection of disabled persons (April 2008).<br><br> 24. The subject has any other unsuitable condition (such as factors reducing the<br> follow-up compliance) to be determined by the investigator.<br><br> 25. The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint<br> of the subjects was grade IV.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WOMAC score
- Secondary Outcome Measures
Name Time Method MRI quantitative analysis of articular cartilage;WOMAC Score;VAS Score;SF-36;MRI quantitative analysis of articular cartilage;Whole-Organ Magnetic Resonance Imaging Score;mJSW;Adverse Events and Serious Adverse Events;Physical examination