New cell patch could ease knee arthritis pain without replacement
NCT ID NCT06549686
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests whether a lab-grown sheet of human cartilage cells (CLS2901C) can improve knee function and reduce pain in people with knee osteoarthritis. About 96 adults aged 20–79 who need knee realignment surgery will receive either the cell sheet plus surgery or surgery alone. The main goal is to measure changes in pain, symptoms, daily activities, and quality of life one year after treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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(including PRP) 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. 14. No history of treatment with radiofrequency ablation of peripheral nerves in the knee joint within 1 year prior to informed consent. 15. No history of proximal tibial osteotomy in the non-target knee. 16. No history of treatment using mesenchymal stem cells, mesenchymal stromal cells, or stem cell culture supernatant. 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. 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\) Received treatment as part of 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ebina General Hospital/Ebina Medical Plaza
RECRUITINGEbina, Kanagawa, 243-0433, Japan
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Juntendo University Hospital
RECRUITINGBunkyō-Ku, Tokyo, 113-8431, Japan
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Tokai University Hospital
RECRUITINGIsehara, Kanagawa, 259-1193, Japan
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Yokohama City University Medical Center
RECRUITINGYokohama, Kanagawa, 232-0024, Japan
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Yokohama Minami Kyousai Hospital
RECRUITINGYokohama, Kanagawa, 236-0037, Japan
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Yokohama Sekishinkai Hospital
RECRUITINGYokohama, Kanagawa, 230-0062, Japan
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Other studies related to the condition(s) this trial covers.
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