Knee osteoarthritis Knee osteoarthritis
Conditions
Interventions
investigational material
Generic name: Human allograft tissue
INN of investigational material: Human allograft tissue
Therapeutic categoly code: -
Dosage and Administration for investigational materia
Sponsors
Tamura Tomoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with osteoarthritis of the knee 2) Patients whose treatment area is between 2 cm2 and 18 cm2 on MRI and whose cartilage damage is focal 3) Patients who have undergone conservative treatment, including physical therapy, for three months prior to screening without success 4) Patients whose WOMAC total score is 20 or more and whose WOMAC Pain score is 5 or more at screening 5) Patients who are candidates for hyaluronic acid joint injections etc.
Exclusion criteria
Exclusion criteria: 1) Patients in stage 4 of the Kellgren-Lawrence (KL) classification 2) Patients with varus or valgus deformity of the knee of 5 degrees or more compared to the normal value (FTA 175 degrees) 3) Patients with surgical treatment that requires treatment of the affected joint, or patients who have had surgical treatment of the knee joint within 3 months 4) Patients who have had osteotomy around the knee in the affected joint within 12 months 5) Patients with a BMI of 30 or more 6) Patients with cartilage defects in both knee joints 7) Patients with inflammatory arthritis associated with autoimmune diseases such as rheumatoid arthritis 8) Patients with inflammatory arthritis such as gout or pseudogout 9) Patients undergoing treatment for hyperuricemia 10) Patients with a history of hypersensitivity to bovine-derived proteins, porcine-derived proteins, and rice-derived proteins 11) Patients with a history of hypersensitivity to aminoglycoside antibiotics and polyene antibiotics 12) Patients who cannot use MRI etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy safety Efficacy:Change in WOMAC Safety:The incidence of Adverse events and defect | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy safety Evaluation on Clinical Symptons:Evaluation by KOOS , IKDC score, VAS, SF-36 Evaluation on regenaration of cartilage tissue: arthroscopy, MRI, evaluation of the cartilage biopsy | — |
Contacts
Public ContactTomoaki Tamura
interstem CO.,Ltd
Outcome results
None listed