Actively Recruiting
A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
Led by CellSeed Inc. · Updated on 2025-11-24
96
Participants Needed
6
Research Sites
405 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 20 to 79 years at informed consent
- Diagnosis of osteoarthritis of the knee classified as Kellgren-Lawrence Grade 2 to 4
- Knee eligible for proximal tibial osteotomy with range of motion of at least 120 degrees flexion and no more than 5 degrees extension
- Preoperative cartilage defect in femoral condyle, trochlear groove, or medial tibial condyle with area of 4 cm2 or more per defect
- Total cartilage defect area no greater than 21 cm2 for multiple defects
- Body mass index (BMI) less than 30
- No ligament injury requiring surgery or meniscal injury requiring suturing or surgical repair other than partial resection in target knee
- No history of ligament reconstruction, meniscal suturing, total meniscectomy, bone marrow stimulation, or regenerative medicine treatments in target knee
- No treatment with hyaluronic acid or opioids for severe pain in target knee within 1 month prior to consent
- No corticosteroid or immunosuppressive drug treatment in target knee within 3 months prior to consent
- No platelet-rich plasma therapy within 6 months prior to consent
- Non-smoker or agrees to abstain from smoking from 3 months before surgery until postoperative bone healing
- Provided written informed consent voluntarily
You will not qualify if you...
- Requires surgical treatment of the non-target knee during the study period
- Any illness interfering with surgery under general anesthesia or affecting knee surgery
- Systemic inflammatory diseases such as rheumatoid arthritis
- Active systemic infections including bacterial, fungal, or viral
- Serious diseases such as liver, kidney, heart, lung, blood, or metabolic disorders making participation unsuitable
- Diagnosed or suspected malignant tumor or history of cancer within past 5 years
- Uncontrolled psychiatric disorder
- Poorly controlled diabetes with HbA1c over 7.0%
- Septic arthritis of the target knee
- Women who are pregnant, breastfeeding, or of childbearing potential without agreed contraceptive use or abstinence
- Participation in another clinical study within past 6 months or planned participation concurrently
- Known allergy to certain antibiotics or bovine-derived materials
- Any other reason deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Ebina General Hospital/Ebina Medical Plaza
Ebina, Kanagawa, Japan, 243-0433
Actively Recruiting
2
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
Actively Recruiting
3
Yokohama Sekishinkai Hospital
Yokohama, Kanagawa, Japan, 230-0062
Actively Recruiting
4
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
5
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, Japan, 236-0037
Actively Recruiting
6
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan, 113-8431
Actively Recruiting
Research Team
C
Chikako Sato
CONTACT
K
Kari Muraoka
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here