Knee osteoarthiritis
Conditions
Interventions
Under echo guidance, S-ADSC s is administered intra-articularly using a 21G needle. For each injection, administer the entire amount of two adhesive culture vessels. Since there are 42000 Cavities in
Sponsors
Sobajima Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with dysfunction associated with osteoarthritis -Over 20 years old when obtaining consent -Diagnosed with osteoarthritis of the knee at our hospital, and there is no improvement even after implementing standard conservative therapy (hyaluronic acid injection and physical therapy) that is fully covered by insurance for more than 3 months. -After standard conservative therapy for 3 months or more, pain evaluation value of 40 or more by visual analogue scale -Don't wish to perform artificial joint replacement or osteotomy -Obtain written consent sufficient explanation about this study -Able to comply with a fixed schedule
Exclusion criteria
Exclusion criteria: -Patients who have difficulty in subcutaneous liposuction -Patients with cancer -Pregnant women, lactating women and patients who may become pregnant -Patients using anticancer drugs, biopharmacy or immunosuppressive drugs -Patients with active infection -Patients who have received intra-articular transplantation of S-ADSCs in the past -Patients who have received this treatment within 1 month -Patients with serious complications (heart disease, lung disease, liver disease, renal disease, bleeding tendency, uncontrolled diabetes and hypertension, etc.) that the doctor deems inappropriate -Patients with a history of drug hypersensitivity to anesthetics, etc. -Other patients who the attending physician deems inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As an evaluation of the effectiveness of S-ADSCs transplantation, pain evaluation by listening to VAS, KOOS evaluation, and MRI image evaluation will be performed. Evaluation of VAS and KOOS will be performed at the time of enrollment and at the 4th, 12th, and 26th weeks after S-ADSCs transplantation. There are two types of MRI imaging conditions: normal imaging with PD and T2 star MERGE, and T2 mapping. For evaluation, MRI osteoarthritis knee score (MOAKS) is used to evaluate bone marrow lesions, cartilage defects, osteophytes, synovitis, and joint edema, and cartilage is evaluated by T2 mapping. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Adverse event occurrence rate For each adverse event, determine the frequency of the worst grade from cell transplantation by CTCAE v5.0-JCOG. (2) WOMAC will be conducted as an evaluation of the effectiveness of S-ADSCs transplantation. WOMAC will be evaluated at the time of enrollment and at the 4th, 12th, and 26th weeks after transplantation of S-ADSCs. | — |
Countries
Japan
Contacts
Public ContactYusuke Harada
Sobajima Clinic
Outcome results
None listed