ALT001 injections to reduce knee osteoarthritis pain and improve joint function

Single-Center, Randomized, Double-Blind, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of ALT001 for Osteoarthritis

This trial will test whether ALT001 injections can reduce pain and improve knee movement and daily quality of life for adults aged 50–75 with knee osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07404891 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled trial enrolling about 30 participants who will continue conventional therapy and be randomly assigned 1:1:1 to placebo, low-dose, or high-dose ALT001. Participants will receive two vials injected into the affected knee every two weeks for six total injections, with follow-up visits through 24 weeks to collect efficacy and safety data. Primary assessments include pain intensity, joint motor function, and quality-of-life measures, while safety monitoring will record adverse events, their severity, and duration. The trial aims to define the clinical benefit and safety profile of ALT001 to inform individualized treatment and guideline decisions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–75 with knee osteoarthritis (Kellgren-Lawrence grade I–III), BMI 18–35, and moderate walking or stair pain who meet the stated inclusion criteria.

Not a fit: Patients with very advanced osteoarthritis (Kellgren-Lawrence grade IV), inflammatory or non-degenerative joint disease, BMI or age outside the specified range, or major comorbidities may be unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, ALT001 injections could provide greater pain relief and improved joint function and quality of life compared with placebo for people with knee osteoarthritis.

How similar studies have performed: Intra-articular injection approaches (e.g., corticosteroids, hyaluronic acid, some biologics) have shown mixed but sometimes meaningful short-term symptom relief, while ALT001 itself is investigational with limited public data.

Eligibility criteria

Inclusion Criteria:

1. Aged 50 to 75 years old (inclusive), gender unrestricted;
2. Body Mass Index (BMI) within the range of 18 ≤ BMI ≤ 35;
3. Meets the diagnostic criteria for osteoarthritis (OA) in Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 Edition) \[1\]. A diagnosis of knee osteoarthritis can be made if criterion ① plus any 2 of criteria ②, ③, ④, ⑤ are satisfied:

   ① Recurrent knee pain within the past 1 month;

   ② X-ray (standing or weight-bearing position) shows narrowed joint space, subchondral bone sclerosis and/or cystic changes, and osteophyte formation at the joint margin;

   ③ Aged ≥ 50 years;

   ④ Morning stiffness duration ≤ 30 minutes;

   ⑤ Crepitus (sensation or sound) during joint movement;
4. Kellgren-Lawrence grade of Grade Ⅰ to Ⅲ for at least one knee joint on anteroposterior and lateral (stress) X-ray of bilateral knee joints within 6 months;
5. A score of 4 to 8 points (inclusive) for pain on flat ground walking or stair climbing in the WOMAC Pain Score of at least one knee joint;
6. For participants who have been taking glucosamine or diacerein-containing drugs before the screening period, the dosage must be kept stable throughout the entire clinical trial;
7. Discontinued all analgesic drugs for more than 2 weeks before the screening period, and agreed not to use any other analgesic drugs except rescue medication throughout the entire study;
8. Willing to cooperate with the clinical trial and able to sign the informed consent form.

Exclusion Criteria:

1. With other diseases that cause knee pain and dysfunction (e.g., autoimmune arthritis, infectious arthritis, gouty arthritis, knee joint tumors, etc.);
2. With pain in other body parts exceeding knee pain, which may interfere with the assessment of the knee joint;
3. With significantly narrowed joint space or bony ankylosis due to bone bridge formation between joints;
4. With lower extremity pain caused by lumbar spinal stenosis or lumbar disc herniation;
5. With systemic infection or severe local infection;
6. With clinically significant abnormalities in any item of the four infectious disease screening tests;
7. With a history of knee joint surgery, open trauma within 1 year, or intra-articular injection, radiotherapy, or arthroscopy within 6 months;
8. With intra-articular corticosteroid block therapy for the knee joint or long-term (continuous ≥2 weeks) use of corticosteroids or immunosuppressants within 6 months;
9. With a history of taking Chinese herbal decoctions or proprietary Chinese medicines for knee pain within 1 month;
10. With physical therapy or topical medication (e.g., electromagnetic therapy, cupping, acupuncture, plasters, fumigation, etc.) on the knee joint within 1 week;
11. With severe diseases of the heart, brain, liver, kidney, hematologic, endocrine, or immune systems (e.g., AST/ALT or creatinine ≥2.0×ULN, glycosylated hemoglobin ≥8%, hemophilia, etc.);
12. With malignant tumors;
13. Planning to undergo elective knee joint surgery during the study period;
14. With obvious knee joint effusion (significant joint swelling or bulging) or severe venous/lymphatic stasis of the lower extremities;
15. Requiring long-term use of warfarin or other anticoagulants (except for a stable daily dose of aspirin ≤100 mg and/or clopidogrel);
16. With consciousness disturbance or mental illness, unable to complete self-assessment;
17. With a history of drug abuse or alcoholism;
18. With a history of allergy to the raw materials of the study product and control product, or atopic diathesis (previous allergy to protein-based drugs or food);
19. With a positive pregnancy test, pregnant/lactating women, those with recent childbearing plans, or those unable to take reliable contraceptive measures during the study;
20. Having participated in other clinical trials of drugs, biological agents, or medical products within 3 months;
21. Other circumstances deemed inappropriate for participation in this clinical trial by the investigator.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaodong Guo, PhD

Conditions Osteoarthritis