Osteoarthritis
Conditions
Interventions
Interventional administration of 10^6 or 10^7(about 2.5 cc) of chondrocyte spheroids using a 23G needle with echo guide or arthroscope
Sponsors
Hayashi Shuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) KL Grade I or higher osteoarthritis patients 2) Patient who have pain (VAS>4) at the target site more than 3 months before the date of consent 3) Men and women whose consent acquisition date is more than 18 years and less than 100 years 4) Patients who can appropriately evaluate pain from start of screening to the end of observation for 48 weeks 5) Patients who have received sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in the study group based on their free will 6) Patients who can follow the scedule established until the end of the examination period
Exclusion criteria
Exclusion criteria: 1) Patients with pain other than the primary disease corresponding to any of the following within 7 days before the first administration day-Pain other than the target site suring the screening period average 4 or more (Lumbar spinal canal stenosis, etc.) 2) Patients who have inflammatory diseases other than synovitis due to the primary disease at the target site on the screening test day or the first administration day, or patients with a history of these diseases within one year before obtaining consent 3) Patients who have undergone surgical procedures including arthroscopy for the disease site (exclucding drainage of joint fluid) 4) Patients who received physical therapy of the primary disease within 28 days before the screening start date 5)Patients with a history or complication of malignancy within 5 years before obtaining consent 6) Patients with the following symptoms or diseases that may affect the results -patients with severe heart disease, liver disease, kidney disease, blood disease or immunodeficiency -patients with systemic joint disease such as rheumatoid arthritics and gout -patients with peripheral neuropathy -patients with osteonecrosis of the disease site -patients with mental illness such as depression, dementia, schizophenia and anxiety -patients scheduled for surgery during the period from the date of consent to the end of observation for 12 months 7) Patients who have a history or complication of drug dependence or alcoholism 8) Patients iudged inappropriate by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of chondrocyte spheroids differentiated from adipose-derived mesenchymal stem cells by cell number for osteoarthritis adversedrugreaction, adverse event, Serious adverse event,, laboratory evidence | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of chondrocyte spheroids differentiated from adipose-derived mesenchymal stem cells by cell number for osteoarthritis physiological function test imaging test (CT, MRI ) Evaluation of knee joint pain : Visual Analogue Scale (VAS) | — |
Countries
Japan
Contacts
Public ContactMamoru Ishihara
Clinic Tokyo Toranomon COR
Outcome results
None listed