A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee

Launched by CELLSEED INC. · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CLS2901C for people with osteoarthritis of the knee. Osteoarthritis is a condition that causes pain and stiffness in the joints, particularly in the knees. In this study, researchers want to find out if using CLS2901C, which involves special cell sheets, can improve outcomes when combined with a surgical procedure called osteotomy (which realigns the knee) compared to just doing the osteotomy alone.

To be eligible for this trial, participants need to be between 20 and 79 years old and have osteoarthritis that is moderate to severe, as confirmed by X-rays. They should also have specific types of cartilage damage in their knee and meet certain health criteria, such as a body mass index below 30. If you decide to join the study, you can expect to undergo the surgical procedure and be monitored for safety and effectiveness during the healing process. It’s important to know that there are several health conditions and treatments that could exclude someone from participating, so discussing your health history with the research team will be essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 20 to 79 years at informed consent.
• • 2. Diagnosis of OAK classified as Kellgren-Lawrence (K-L) Grade 2 to 4 based on plain lower extremity X-ray.
• • 3. OAK eligible for proximal tibial osteotomy based on the following criteria: Range of motion (ROM): \>=120 degree flexion, \<=5 degree extension
• • 4. Preoperative cartilage defect of the femoral condyle/trochlear groove or medial tibial condyle with an area of \>=4 cm2 per defect site.
• • 5. Total defect area of \<=21 cm2 in individuals with multiple cartilage defects.
• • 6. Body mass index (BMI) \<30.
• • 7. No coexisting ligament injury requiring surgery, and no meniscal injury requiring suturing or surgical repair other than partial resection, in the target knee.
• • 8. No history of ligament reconstruction, meniscal suturing, total meniscectomy or bone marrow stimulation, and no history of treatment with regenerative medicine products (including investigational products), cell processing products or gene therapy, in the target knee.
• • 9. No history of treatment with hyaluronic acid products and/or opioid for severe pain in the target knee within 1 month prior to informed consent.
• • 10. No history of treatment with corticosteroid products and/or immunosuppressive drug in the target knee within 3 months prior to informed consent.
• • 11. No history of platelet-rich plasma (PRP) therapy within 6 months prior to informed consent.
• • 12. Non-smoker; provided, however, that smokers will be eligible for study entry if they consent to abstain from smoking from 3 months prior to proximal tibial osteotomy or proximal tibial osteotomy+RMSC until postoperative bone healing.
• • 13. Written informed consent to participate in the study on a voluntary basis.
• Exclusion Criteria:
• • 1. Requires surgical treatment of the non-target knee during the study period.
• • 2. Any coexisting illness that would interfere with surgery under general anesthesia or that would affect knee surgery.
• • 3. Systemic inflammatory disease such as rheumatoid arthritis.
• • 4. Active infectious disease such as bacterial, fungal or viral infection.
• • 5. Positive serology assay result (HBs antigen, HBc antibody/HBs antibody, HCV antibody, HIV-1/2 antibody, HTLV-1 antibody, Treponema pallidum antibody) or positive nucleic acid amplification assay result (HBV-DNA, HCV-RNA, HIV-RNA). However, patients who return a positive assay result for HBs antibody and negative assay result for HBV-DNA due to inoculation with hepatitis B vaccine will still be eligible for study entry.
• • 6. Serious disease such as liver disorder, renal disorder, heart disease, lung disease, blood disease or metabolic disease that would make the patient unsuitable for study entry in the opinion of the investigator.
• • 7. Diagnosed or suspected malignant tumor or history of malignant tumor within the past 5 years.
• • 8. Uncontrolled psychiatric disorder.
• • 9. Poorly-controlled diabetes (HbA1c: \>7.0%).
• • 10. Previous history of septic arthritis of the target knee.
• • 11. Women who are pregnant or breastfeeding, or women of childbearing potential. Women of childbearing potential must agree to use the following contraceptive methods (i.e., contraceptives and medical devices that are approved/certified in Japan) or to abstain completely from sexual intercourse from the time of informed consent and for the study duration (excluding the follow-up period) in order to be eligible for study entry. (a) Primary contraceptive methods: Oral contraceptives, intrauterine devices (IUDs) including progesterone-releasing systems. (b) Adjunctive contraceptive methods: Condoms Use of a primary contraceptive method is mandatory, whereas use of the adjunctive contraceptive method must be in conjunction with a primary contraceptive method. Given that oral contraceptive doses can be missed and that their effects may be diminished when used concomitantly with other medications or dietary health supplements, subjects should consider changing their primary contraceptive method.
• • 12. Participated in another clinical study within the past 6 months, currently participating in another clinical study, or planning to participate in another clinical study while also participating in the present study.
• • 13. Known history of hypersensitivity to antibiotics (benzylpenicillin potassium, streptomycin sulfate, amphotericin B).
• • 14. Known history of hypersensitivity to bovine-derived materials.
• • 15. Any other reason the investigator deems the subject unsuitable for study entry.