Single-center, first-in-human injection of ceAF for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, open-label, dose-escalation study conducted at a single center to evaluate intra-articular ceAF in adults with knee osteoarthritis. Part 1 tests three dose levels (1.0, 1.5, and 2.0 mL) with 3-5 participants per level to establish safety and initial signals of efficacy. Part 2 administers the most favorable dose weekly for 2-3 injections to an additional 6-10 participants. Participants are followed for 12 weeks after the last injection, with safety monitoring and assessments of structural and patient-reported outcomes. The study uses imaging and clinical scales to track changes from baseline in knee structure and function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant (or legal representative) voluntarily agrees to participate and provides written informed consent.
2. Age 18-70 years, inclusive; male or female.
3. Definite diagnosis of knee osteoarthritis according to the 2010 diagnostic criteria of the Rheumatology Branch of the Chinese Medical Association.
4. Duration of knee osteoarthritis of 6 months or more and less than 10 years.
5. Knee pain VAS score of 4 or more and less than 8 in both knees, assessed at least 3 days after discontinuation of all analgesic medication.
6. Kellgren-Lawrence grade III or IV on X-ray of both knees.
7. Able to walk independently; participants requiring crutches, a walker or a wheelchair are not eligible.

Exclusion Criteria:

1. Allergy to one or more drugs, to eggs, or to two or more foods.
2. Body mass index greater than 30 kg/m2.
3. Uncontrolled or difficult-to-control cardiovascular, cerebrovascular, hepatic, renal, pulmonary, endocrine or other systemic disease.
4. History of malignant tumour.
5. Concomitant systemic or rheumatic arthritis chondropathy, chondrocalcinosis, haemochromatosis, infectious arthropathy, avascular necrosis of the femoral head, Paget's disease, haemophilic arthropathy, Charcot arthropathy, pigmented villonodular synovitis or synovial chondromatosis.
6. Relatively severe systemic infection, or local knee joint infection (including skin and intra-articular infection), within 3 months before the start of the study.
7. Relatively severe lower limb disease that may interfere with knee assessment, such as fibromyalgia, significant low back pain or lumbar disc herniation.
8. Coagulation disorder.
9. Knee arthroscopic surgery, or other open surgery involving the knee, within 6 months before the start of the study.
10. Intra-articular injection for knee osteoarthritis within 6 months before the start of the study, including but not limited to hyaluronic acid, corticosteroids, platelet-rich plasma and bone morphogenetic protein.
11. Glucosamine and/or chondroitin sulfate treatment within 4 weeks before the start of the study.

Where it's running

• Huangshan People's Hospital
  Huangshan City, Anhui, China Recruiting

Study contacts

• Study coordinator: WENLIAN XU, PhD
• Email: xuwenlian@hygeiancells.com
• Phone: +86 13811619762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.