Knee osteoarthritis Knee pain, Cartilage abrasion, Osteophyte formation
Conditions
Interventions
Amniotic membrane mesenchymal stem cells, which are isolated and cultured using enzyme treatment from amniotic membranes collected from healthy pregnant women, are injected into the knee joint cavity
Sponsors
Sato Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients have been diagnosed with knee osteoarthritis and have been receiving ongoing treatment 2. Patients have the ability to make decisions, have been fully informed about the treatment, and understand and agree to the treatment 3. Patients are with good systemic condition 4. Patients are 20 years old and over 5. Patients whose gender does not matter
Exclusion criteria
Exclusion criteria: 1. Patients with cancer or undergoing cancer treatment 2. Patients in whom human immunodeficiency virus infection cannot be ruled out 3. Patients who have undergone regenerative cell therapy within the past year 4. Patients with a history of surgery in the knee joint. osteosynthesis, meniscus surgery, ligament reconstruction surgery, etc. 5. Patients with idiopathic osteonecrosis SONK or steroid-induced osteonecrosis 6. Patients with traumatic cartilage defects or osteochondritis dissecans 7. Patients with poorly controlled ischemic heart disease, diabetes, mental disorders, and liver disease 8. Patients with inflammatory diseases. rheumatoid arthritis, psoriasis, gout, pseudogout, SLE, Behcet's disease, reactive arthritis, polymyositis, etc. 9. Patients with allergies to aminoglycoside antibiotics such 10. Patients with sepsis 11. Patient with renal dysfunction undergoing treatment 12. Patients with sensitivities or allergic predispositions, excluding those with hay fever 13. Pregnant women, nursing mothers, and patients who may be pregnant 14. Patients deemed inappropriate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (comprehensive assessment) Safety is evaluated from two aspects: 1. The occurrence of adverse events and severe adverse events (content, frequency) 2. Occurrence of dose-limiting toxicities (contents, frequency) | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory efficacy 1. KOOS and Lysholm score 2. Image evaluation (X-ray, MRI) 3. Biomarkers | — |
Countries
Japan
Contacts
Public ContactIzumi Tsuchiya
Tokai University
Outcome results
None listed