Traumatic cartilage defect of the knee joint and osteochondritis dissecans
Conditions
Interventions
investigational material(s)
Generic name etc : CCI kit
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : The cultured c
Sponsors
Interstem CO .,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with traumatic cartilage defect of the knee joint and osteochondritis dissecans 2)Patients applying microfractures 3)Patients with clinical symptoms in the knee joint 4)Patients with KOOS 5 of 70 or less at screening 5)Patients with a cartilage defect area from 2 cm2 to 9 cm2 etc
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed with osteoarthritis and patients with Kellgren-Lawrence classification stage 2 or higher 2)Patients with inflammatory arthritis associated with autoimmune diseases such as rheumatoid arthritis 3)Patients with cartilage defect in both knee joints 4)Patients with multiple cartilage defect 5)Patients with a bone defect with a depth of 8 mm or more at the cartilage defect site 6)Patients who have a history of surgery for adjustment of joint alignment or who need it etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy:Change in KOOS Safety:The incidence of Adverse events and defect | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Evaluation on Clinical Symptoms: Evaluation by KOOS Subscore, IKDC, Lysholm Score Evaluation on regeneration of cartilage tissue: arthroscopy, MRI, evaluation of the cartilage biopsy Status of re-intervention treatment: Evaluation of the rate of re-intervention treatment | — |
Countries
Japan
Contacts
Public ContactTamura Tomoaki
Interstem CO .,Ltd
Outcome results
None listed