Actively Recruiting
Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-03-24
30
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial will focus on the core efficacy endpoints including relief of pain intensity, improvement of joint motor function and enhancement of quality of life in patients. Meanwhile, it will strictly monitor key safety indicators such as the occurrence of various adverse events after medication, the severity and duration of adverse reactions, and conduct a multi-dimensional and multi-level comprehensive assessment. The study aims to clarify the clinical benefit profile and safety risks of the investigational product ALT001, and provide scientific, detailed and reliable evidence-based medical data to support the optimization of clinical treatment guidelines and the formulation of individualized treatment regimens for knee osteoarthritis. Patients enrolled in the trial will receive investigational product treatment on the basis of conventional therapy. They will be randomly assigned to the placebo group, low-dose group and high-dose group at a ratio of 1:1:1. For each treatment course, patients in all groups will receive an injection of 2 vials of the investigational product into a single knee joint (for bilateral knee osteoarthritis, both knees may be injected, with one fixed knee joint selected for subsequent assessments). The injection will be administered once every 2 weeks for a total of 6 administrations.
CONDITIONS
Official Title
Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 75 years old, any gender
- Body Mass Index (BMI) between 18 and 35
- Diagnosed with knee osteoarthritis based on specific Chinese guidelines, including recurrent knee pain and at least two other criteria such as X-ray changes, age over 50, morning stiffness lasting 30 minutes or less, or joint crepitus
- Kellgren-Lawrence grade I to III on recent knee X-rays
- WOMAC Pain Score between 4 and 8 for walking on flat ground or stairs in at least one knee
- Stable dosage of glucosamine or diacerein drugs if used before screening
- Stopped all analgesic drugs at least 2 weeks before screening and agree not to use other analgesics except rescue medication during the study
- Willing to cooperate and able to sign informed consent
You will not qualify if you...
- Other diseases causing knee pain or dysfunction such as autoimmune, infectious, or gouty arthritis, or knee tumors
- Pain in other body parts worse than knee pain that may affect assessments
- Severely narrowed joint space or bony ankylosis with bone bridge formation
- Lower limb pain caused by lumbar spinal stenosis or disc herniation
- Systemic or severe local infections
- Abnormal infectious disease screening tests
- History of knee surgery, open trauma within 1 year, or intra-articular treatments within 6 months
- Use of corticosteroid block therapy or long-term corticosteroids/immunosuppressants within 6 months
- Use of Chinese herbal medicines for knee pain within 1 month
- Physical therapy or topical knee treatments within 1 week
- Severe diseases of heart, brain, liver, kidney, blood, endocrine, or immune systems
- Malignant tumors
- Planning elective knee surgery during the study
- Obvious knee joint effusion or severe venous/lymphatic stasis
- Need for long-term anticoagulants except low-dose aspirin or clopidogrel
- Mental illness or consciousness disturbances preventing self-assessment
- History of drug abuse or alcoholism
- Allergy to study product or control product components
- Pregnancy, lactation, or inability to use reliable contraception
- Participation in other clinical trials within 3 months
- Any other condition deemed unsuitable by the investigator
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Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
X
Xiaodong Guo, PhD
CONTACT
Z
Zekang Xiong, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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