Knee osteoarthritis
Conditions
Sponsors
Sobajima Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with functional impairment associated with knee osteoarthritis -Must be 20 years of age or older at the time of 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 performing standard conservative therapy for 3 months or more, the value of pain evaluation by visual analogue scale must be 30 or more. - Do not wish to undergo artificial joint replacement surgery or osteotomy -Written consent must be obtained from the individual after receiving a sufficient explanation about this research. -Ability to adhere to a set schedule
Exclusion criteria
Exclusion criteria: Patients with any of the following are excluded. -Patients for whom subcutaneous liposuction is difficult -Patients with cancer -Patients using anticancer drugs, biologics, or immunosuppressants -Patients who are pregnant, breastfeeding, or may become pregnant -Patients with active infection -Patients who have received Ch-ADSCs transplantation into the knee joint cavity in the past -Patients who have serious complications (cardiac disease, lung disease, liver disease, renal disease, bleeding tendency, uncontrolled diabetes, hypertension, etc.) and are judged unsuitable by a doctor -Patients with a history of allergy to bovine-derived proteins -Patients with a history of severe allergies other than those mentioned above -Patients with a history of drug hypersensitivity to anesthetics, etc. -Other patients who are deemed inappropriate by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Occurrence rate of adverse events 26 weeks after Ch-ADSCs transplantation] Regarding adverse events, we will calculate the frequency of the worst grade from fat collection by CTCAE v5.0-JCOG to 26 weeks later. | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy 26 weeks after Ch-ADSCs transplantation] To evaluate the efficacy of Ch-ADSCs transplantation, pain evaluation by VAS listening, KOOS evaluation, and MRI image evaluation will be performed. VAS and KOOS evaluations are performed at enrollment and 4, 12, and 26 weeks after Ch-ADSCs transplantation. MRI examinations are performed at enrollment and 26 weeks. There are two types of MRI imaging conditions: normal imaging such as 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. | — |
Countries
Japan
Contacts
Public ContactYusuke Harada
Sobajima Clinic
Outcome results
None listed