NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2063210037

Registered date:05/10/2021

Investigator-initiated Clinical Trial to Evaluate the Safety and Efficacy of Magnetic targeting using Autologous Bone Marrow-derived Mesenchymal Stem Cell (m-MSC) in Knee Osteoarthritis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedKnee Osteoarthritis
Date of first enrollment20/10/2021
Target sample size5
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)After the arthroscopic bone marrow stimulation technique is performed on the articular cartilage defect, a suspension of bone marrow derived m-MSCs from the subject is injected in the presence of a magnetic field. The magnetic field is maintained for 10 minutes after cell transplantation.

Outcome(s)

Primary Outcome1) Incidence rate of adverse events (%) and incidence rate of defects (%) 2) Confirmation of the occurrence of significant adverse events (neoplastic lesions, allergic symptoms, and unknown infections for which a causal relationship cannot be denied as risks specific to regenerative medical products)
Secondary Outcome1) IKDC subjective score 2) Knee Injury and Osteoarthritis Outcome Score (KOOS) 3) Plain X-ray (Kellgren-Lawrence grading) 4) Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score: MRI evaluation 5) International Cartilage Repair Society (ICRS) score: Arthroscopic evaluation (for patients who have consented to arthroscopy) 6) Histological evaluation (for patients who have consented to biopsy)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1) Patients whose age is between 20 and 80 years old at the time of obtaining consent 2) Patients whose written consent has been obtained 3) Patients who have been diagnosed with knee osteoarthritis 4) Patients with Kellgren-Lawrence classification grade 2 or 3 osteoarthritis on X-ray examination 5) Patients whose articular cartilage damage is limited to the medial condyle or lateral condyle 6) Patients who have received conservative treatment, including exercise therapy, for at least 3 months from the time of enrollment 7) Patients with clinical symptoms of pain in the knee
Exclude criteria1) Patients who have undergone reconstruction of the anterior cruciate ligament and/or posterior cruciate ligament within 2 months of enrollment in the study 2) Patients scheduled for treatment of meniscus injury or patients who have undergone surgery for meniscus injury within 6 months of enrollment in the study 3) Patients with knee deformity inward or outward more than 10 degrees from the normal value (FTA 175 degrees) 4) Patients with implanted medical devices that may be affected by magnetic fields 5) Patients with malignant tumors, suspected malignant tumors, or with a history of malignant tumors within 5 years 6) Patients who are pregnant or may be pregnant, who are breast-feeding, or who wish to become pregnant during this study 7) Patients with psychiatric disorders 8) Patients with a history of hypersensitivity to ferucarbotran components or iron injection 9) Patients with iron overload such as hemochromatosis 10) Patients with active bleeding 11) Patients with allergy to animals (bovine or porcine) 12) Patients with hypersensitivity to gentamicin or amphotericin B, and patients with a history of hypersensitivity to aminoglycoside antibiotics 13) Patients who are positive for beef allergy test 14) Patients who are positive for any of the following tests; HBs antigen test, HCV antibody test, or HIV antibody test 15) Other patients who are judged by the investigator or sub-investigator to be inappropriate to participate in this study

Related Information

Contact

Public contact
Name Naosuke Kamei
Address Kasumi 1-2-3 Minami-ku, Hiroshima-city, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5555
E-mail nahkamei@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Naosuke Kamei
Address Kasumi 1-2-3 Minami-ku, Hiroshima-city, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5555
E-mail nahkamei@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital