Traumatic articular cartilage defects or Osteochondritis dissecans of the knee or elbow
Conditions
Interventions
investigational material(s)
Generic name etc : dMD-001
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Fill dMD-001 in
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)Patients who are KOOS of 70 or less 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 defects 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 exploratory Efficacy: KOOS Timmerman/Andrews Elbow score Arthroscopic evaluation, MRI evaluation Safety: Adverse events and defect Efficacy: Change in KOOS Change in Timmerman/Andrews Elbow score Evaluation of the cartilage defect site by Arthroscopic, Evaluation of the cartilage defect site by MRI Safety: The incidence of Adverse events and defect | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory Efficacy: Biopsy Safety: Adverse device effect Efficacy: Evaluation of the cartilage by Biopsy Safety: The incidence of Adverse device effect | — |
Countries
Japan
Outcome results
None listed