Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07902128

PHASE1

A Single-Center Phase 1 Study of ceAF for Knee Osteoarthritis (KOA)

Sponsor: Anhui HygeianCells BioMedical Co., Ltd.

View on ClinicalTrials.gov

Summary

Approximately 25 participants aged 18-70 years, with knee pain rated 4-7 on a 10-point visual analogue scale (VAS) and a disease duration of 6 months to 10 years, will be enrolled. The study has two parts. In Part 1, participants receive a single intra-articular injection of 1.0 mL, 1.5 mL or 2.0 mL of study product (3-5 participants per dose level, given in ascending order). In Part 2, the dose with the most favourable balance of efficacy and safety in Part 1 is given weekly by intra-articular injection for 2-3 doses to an additional 6-10 participants. Participants are followed for 12 weeks after the last injection. Safety is assessed through adverse events (graded by CTCAE v5.0), vital signs, physical examination, electrocardiogram, clinical laboratory tests (haematology, urinalysis, liver and kidney biochemistry, coagulation) and pregnancy testing. Efficacy is assessed by change from baseline in knee X-ray, knee MRI, the Knee injury and Osteoarthritis Outcome Score (KOOS), the WOMAC index, pain VAS and pain-free walking distance at 4 and 12 weeks after the last dose. The study has no placebo or active comparator group. There is no plan to market the product on the basis of this study.

Official title: A Research Collaboration Project to Evaluate the Efficacy and Safety of Animal Early Embryo Extract ceAF in the Treatment of Patients With Knee Osteoarthritis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-10

Completion Date

2027-11-30

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Knee Arthritis, Osteoarthritis

Interventions

BIOLOGICAL

Animal early embryo extract

A cell-free biological preparation manufactured by Anhui Hygeiancells Co., Ltd. from early chick embryo amniotic fluid, containing composite growth-promoting factors and inflammatory factor inhibitors. Supplied as a sterile injection, 2 mL per bag, stored below -60 °C, shelf life 60 months. Administered by local intra-articular injection into the knee.

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.

Locations (1)

Huangshan People's Hospital

Huangshan City, Anhui, China