Phase I exploratory clinical research on the use of High-Density Mesenchymal Stem Cell Scaffold-Free Autologous Constructs derived from adipose tissue for the donor site of mosaic plasty plugs for osteochondral regeneration therapy

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: HDMAC plug implanted CONDITION: Patients with cartilage injury, osteochondritis dissecans, disengaged osteochondral bone fracture, or idiopathic osteonecrosis of the knee joint PRIMARY OUTCOME: Incidence rate of the adverse events and side effects that occur after grafting SECONDARY OUTCOME: Evaluation of osteochondral regeneration in the HDMAC plug implanted area compared with the non implanted area by MRI and arthroscopy with ICRS scoring 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
Epistemonikos ID: 99f4a61ac77d8d49881f96223c5c62312270ebde
First added on: Aug 23, 2024