Actively Recruiting
Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis
Led by Shanghai IxCell Biotechnology Co., LTD · Updated on 2024-12-06
398
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis. To evaluate the safety of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.
CONDITIONS
Official Title
Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with knee osteoarthritis according to Chinese Medical Association guidelines
- Persistent knee pain for over six months or worsening after stopping conventional treatments
- Kellgren-Lawrence grade II to III in the study knee and grade II or less in the other knee
- WOMAC score between 50 and 150 at screening
- VAS pain score of at least 50 mm in the study knee at screening
- Age between 40 and 80 years with BMI 30 or less
- Able to understand and voluntarily sign informed consent and complete trial procedures
You will not qualify if you...
- Secondary knee osteoarthritis diagnosis
- Other diseases causing knee problems or affecting the joint such as rheumatoid arthritis or infections
- Significant knee deformities over 15 degrees or severe contractures
- Prior stem cell therapy
- Use of opioid or NSAID pain medications within 2 weeks or 7 half-lives before treatment
- Physiotherapy or traditional Chinese medicine for knee arthritis within 6 weeks before treatment
- Local or systemic glucocorticoid treatment within 12 weeks before treatment or requirement during study
- Recent start of glucosamine, chondroitin sulfate, or diacerein within 4 weeks before treatment unless stable long-term use
- Knee joint drug injections within 6 months before treatment
- Major or knee surgery within 24 weeks before consent or planned during study
- Lower limb surgery within 12 weeks before consent
- Unsuitable for MRI due to metal implants
- Planned lower limb surgery within 48 weeks after consent
- Skin diseases or infections near injection site
- Osteoarthritis or hip joint disease requiring treatment on the opposite or same side as study knee
- Allergic reactions to study medication components
- Current or recent (within 5 years) malignant tumors
- Mental disorders or history of drug abuse
- Severe heart, liver, kidney, coagulation, or blood diseases
- Positive for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- Pregnant or breastfeeding women or those refusing contraception during study to 6 months post-study
- Participation in other clinical trials within 3 months before consent
- Investigator-determined unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
J
Jie Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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