Status:
RECRUITING
A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
Lead Sponsor:
CellSeed Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the kn...
Detailed Description
The investigational human cellular based product is a cell sheet made by culturing and growing chondrocytes taken from cartilage tissue derived from patients with polydactyly. To evaluate the efficacy...
Eligibility Criteria
Inclusion
- Male or female aged 20 to 79 years at informed consent.
- Diagnosis of OAK classified as Kellgren-Lawrence (K-L) Grade 2 to 4 based on plain lower extremity X-ray.
- OAK eligible for proximal tibial osteotomy based on the following criteria: Range of motion (ROM): \>=120 degree flexion, \<=5 degree extension
- Preoperative cartilage defect of the femoral condyle/trochlear groove or medial tibial condyle with an area of \>=4 cm2 per defect site.
- Total defect area of \<=21 cm2 in individuals with multiple cartilage defects.
- Body mass index (BMI) \<30.
- No coexisting ligament injury requiring surgery, and no meniscal injury requiring suturing or surgical repair other than partial resection, in the target knee.
- 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.
- 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.
- No history of treatment with corticosteroid products and/or immunosuppressive drug in the target knee within 3 months prior to informed consent.
- No history of platelet-rich plasma (PRP) therapy within 6 months prior to informed consent.
- 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.
- Written informed consent to participate in the study on a voluntary basis.
Exclusion
- Requires surgical treatment of the non-target knee during the study period.
- Any coexisting illness that would interfere with surgery under general anesthesia or that would affect knee surgery.
- Systemic inflammatory disease such as rheumatoid arthritis.
- Systemic Active infectious disease such as bacterial, fungal or viral infection.
- 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) 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.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2031
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06549686
Start Date
October 20 2023
End Date
July 31 2031
Last Update
November 24 2025
Active Locations (6)
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1
Ebina General Hospital/Ebina Medical Plaza
Ebina, Kanagawa, Japan, 243-0433
2
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
3
Yokohama Sekishinkai Hospital
Yokohama, Kanagawa, Japan, 230-0062
4
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024