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

Phase 1

• Conditions: Knee Osteoarthritis

• Registration Number: JPRN-jRCT2063210037
• Lead Sponsor: Kamei Naosuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion 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 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Incidence rate of adverse events (%) and incidence rate of defects (%)<br>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 Outcome Measures

Name	Time	Method
1) IKDC subjective score<br>2) Knee Injury and Osteoarthritis Outcome Score (KOOS)<br>3) Plain X-ray (Kellgren-Lawrence grading)<br>4) Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score: MRI evaluation<br>5) International Cartilage Repair Society (ICRS) score: Arthroscopic evaluation (for patients who have consented to arthroscopy)<br>6) Histological evaluation (for patients who have consented to biopsy)