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New treatment option for Osteoarthritis of the Knee
Official title A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
ClinicalTrials.gov ID: NCT06549686
What this study is testing
What is CLS2901C (human [allogeneic] chondrocyte sheets)?
CLS2901C (human [allogeneic] chondrocyte sheets) is an investigational medicine, being studied as a potential treatment for osteoarthritis of the knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 knee (OAK).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 79
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- Written informed consent to participate in the study on a voluntary basis.
- No history of treatment with radiofrequency ablation of peripheral nerves in the knee joint within 1 year prior to informed consent.
- No history of proximal tibial osteotomy in the non-target knee.
- No history of treatment using mesenchymal stem cells, mesenchymal stromal cells, or stem cell culture supernatant.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Ebina, Kanagawa, Japan
- Isehara, Kanagawa, Japan
- Yokohama, Kanagawa, Japan
- Bunkyō-Ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ebina, Kanagawa, Japan; Isehara, Kanagawa, Japan; Yokohama, Kanagawa, Japan; Bunkyō-Ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.