Transplantation of spheroid adipose-derived stem cells for knee osteoarthritis.
- Conditions
- Knee osteoarthiritis
- Registration Number
- JPRN-jRCTb050220148
- Lead Sponsor
- Sobajima Satoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method (1) Adverse event occurrence rate For each adverse event, determine the frequency of the worst grade from cell transplantation by CTCAE v5.0-JCOG.<br>(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.