osteoarthritis of the knee osteoarthritis
Conditions
Sponsors
Sekiya Ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who participated in "a single-center, double-blind, placebo-controlled, randomized, parallel-group study to evaluate the efficacy and safety of Intraarticular injections of autologous synovial stem cells for knee osteoarthritis (Investigator initiated clinical trial) (Autologous synovial MSC injection into the OA knee)" 2) Patients who were eligible for both shipping inspection and confirmation inspection below - Sterility test - Mycoplasma negative test - Endotoxin test 3) Patients for whom transplantation of autologous synovial stem cell products could not be carried out due to nonconformity for following inspections - Cell number, viable cell ratio - Cell purity evaluation - ECM production ability
Exclusion criteria
Exclusion criteria: 1) Patients with active infection 2) Patients diagnosed or suspected as malignant tumor in these 5 years. 3) Patient with poor controlled diabetes 4) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 5) Patient for whom doctors decide as not appropriate to participate in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) and significant failures from obtaining consent to 30 weeks post-dose or early discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm score, numerical rating scale (NRS), X-ray examination, MRI 3D analysis | — |
Countries
Japan
Contacts
Public ContactHisako Katano
Institute of Science Tokyo
Outcome results
None listed