Traumatic articular cartilage defects or Osteochondritis dissecans of the knee or elbow
Conditions
Interventions
investigational material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : Fill dMD-001 in cartilage def
Sponsors
Mochida Pharmaceutical Co., Ltd.
HOKKAIDO UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with traumatic articular cartilage defects or osteochondritis dissecans of the knee or elbow (2) [Knee]Patients who are IKDC score of 60 or less [Elbow]Patients who are Timmerman/Andrews Elbow score of 140 or less (3) Patients who are cartilage defect area from 1 cm2 to just under 4 cm2 etc.
Exclusion criteria
Exclusion criteria: (1) Patients with 2 or more articular cartilage defects (2) Patients with Osteoarthritis (3) Patients who previously had surgical treatment to articular cartilage injuries of the target site (4) Patients with serious Cardiac disorder, Liver disorder, Kidney disorder, Blood disorder, or Endocrine disorders etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory Efficacy: [Knee]Change in IKDC score [Elbow]Change in Timmerman/Andrews Elbow score Safety: The incidence of Adverse events and defect | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory Efficacy: Each indicator in MRI (3D-MOCART) Safety: The incidence of Adverse device effect | — |
Countries
Japan
Outcome results
None listed