Investigator-initiated Clinical Trial to Evaluate the Safety and Efficacy of AX-1911, Magnetic Field Generator for Magnetic Targeting, in Knee Osteoarthritis

JRCT ID: jRCT2062210039

Registered date:05/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Knee Osteoarthritis
• Date of first enrollment: 20/10/2021
• Target sample size: 5
• Study type: Interventional
• Intervention(s): After the arthroscopic bone marrow stimulation technique is performed on the articular cartilage defect, a suspension of bone marrow fluid-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 Outcome: Incidence rate of adverse events (%) and incidence rate of defects (%)
• Secondary Outcome: Completion rate of procedures using investigational device

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) 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 kneeosteoarthritis
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 criteria

1) 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

• Primary Sponsor: Kamei Naosuke
• Secondary Sponsor: Flying Cell Co., Ltd