Patients with cartilage injury, osteochondritis dissecans, disengaged osteochondral bone fracture, or idiopathic osteonecrosis of the knee joint
Conditions
Interventions
HDMAC plug implanted
Sponsors
Kyushu University Hospital Department of Orthopedic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the eligibility listed below to be enrolled in the trial. 1) Age : >= 20 and <= 60 years old at the time of obtaining informed consent 2) Patients with cartilage injury, osteochondritis dissecans, disengaged osteochondral bone fracture or idiopathic osteonecrosis of the knee joint diagnosed by MRI 3) Patients have a lesion area (shoulder, knee, elbow, joint) larger than 100mm2 4) Patients with normal hematopoietic function (screening test results showing blood composition to be within the following ranges; white blood cell count (3,000-10,000/uL), platelet count (140,000-440,000/uL), hemoglobin (10.0-18.0g/dL). 5) Patients without serious problems on kidney (CRE;0.65-1.07mg/dL for male, 0.46-0.79 mg/dL for female) and liver (ALT;6-90U/L, AST;13-90U/L, total bilirubin;0.3-3.6mg/dL), uncontrolled heart dysfunctions including arrhythmia and angina pectoris, uncontrolled diabetes or high blood pressure 6) Suitable as a subject as results of screening test conducted after obtaining informed consent 7) Participate this trial based on subject's own free will and give informed consent in written form
Exclusion criteria
Exclusion criteria: Subjects that meet the following criteria will be excluded from the trial. 1) Has past undergone osteochondral surgery 2) Has past suppurative arthritis in the affected area 3) Has past rheumatism, gout or other arthritis 4) Has present or past contagious disease within 3 months of registering for the trial 5) Positive for syphilis , HBs antigens, HCV, HIV parvovirus or HTLV antigens in the screening test results 6) Was drawn 200ml of whole blood within one month (or 200ml of blood components was drawn within two weeks) of registering 7) Is currently taking antithrombotic or anticoagulant drugs 8) APTT over 41 seconds and PT over 13.5 seconds in the screening test results 9) Is currently undergoing treatment for a malignant tumor or underwent treatment for a malignant tumor (excluding intraepithelial neoplasia) within the last 5 years 10) Has any congenital metabolism or bone disorders 11) Has past history of drug or alcohol abuse 12) Is taking steroids like prednisolone systemically 5mg/day or is taking any immune suppressant drugs 13) Participate other clinical research within 3 months before registration 14) Has a history of drug hypersensitivity reactions (antibacterial agents using cultivated cells such as penicillin etc) 15) Has hypersensitivity for animals (especially for bovine) 16) Has a history of anaphylaxis 17) Pregnant, capable of pregnancy and lactating women 18) Unsuitable for this trial judged by PI or SI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of the adverse events and side effects that occur after grafting | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of osteochondral regeneration in the HDMAC plug implanted area compared with the non implanted area by MRI and arthroscopy with ICRS scoring | — |
Countries
Japan
Contacts
Public ContactYukio Akasaki
Kyushu University Hospital Department of Orthopedic Surgery
Outcome results
None listed