Actively Recruiting
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis
Led by Wuxi Cellular Biopharmaceutical Group Ltd. · Updated on 2025-07-16
520
Participants Needed
2
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy
CONDITIONS
Official Title
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands and voluntarily signs the consent form before participating
- Diagnosed with knee osteoarthritis based on American Rheumatology Association clinical and radiology criteria
- Has had knee osteoarthritis for more than 6 months
- Aged between 40 and 75 years, male or female
- WOMAC score between 24 and 72
- Kellgren Lawrence grade II or III on knee X-ray
- Generally in good health and able to walk independently without wheelchairs, walking aids, or crutches
You will not qualify if you...
- Allergy to main cell preparation components such as B vitamins or amino acids
- Previous treatment with autologous or allogeneic mesenchymal progenitor cells
- Considered obese
- Abnormal laboratory values including low neutrophil or platelet counts, low serum albumin, high serum creatinine, or elevated liver enzymes
- Conditions that may affect pain or WOMAC scores
- Serious uncontrolled diseases affecting nervous, cardiovascular, liver, kidney, gastrointestinal, or endocrine systems
- History of malignant tumors
- Presence of connective tissue diseases, rheumatoid arthritis, or other specified joint diseases
- Severe infections or local knee infections within 3 months
- Diseases of lower limbs that may interfere with knee evaluation
- Coagulation disorders that pose safety risks or affect evaluation
- Knee surgery within 6 months prior to the trial
- Other intra-articular injections for knee osteoarthritis within 3 months
- Use of aminoglucose or chondroitin sulfate within 1 month before treatment
- Use of steroids orally or intravenously within 1 month before treatment
- Vaccination with attenuated or live vaccines within 1 month before treatment
- Planned or previous knee prosthesis during the trial
- Contraindications to MRI including implanted devices or severe claustrophobia
- Positive tests for HIV, HBV, HCV, or treponema pallidum
- History of alcoholism, drug abuse, or mental illness in past 3 years
- Participation in other clinical trials within 3 months
- Fertility plans, pregnancy, lactation, or positive pregnancy test
- Legal disability under applicable law
- Other conditions reducing follow-up compliance as determined by investigators
- Kellgren Lawrence grade IV on any knee joint X-ray
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
RenJi Hospital
Shanghai, China, China
Actively Recruiting
2
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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