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Clinical study of human umbilical cord mesenchymal stem cell-derived apoptotic vesicles (MSC-apoVs) combined with sodium hyaluronate in the treatment of knee osteoarthritis

Clinical study of human umbilical cord mesenchymal stem cell-derived apoptotic vesicles (MSC-apoVs) combined with sodium hyaluronate in the treatment of knee osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095410
Enrollment
Unknown
Registered
2025-01-07
Start date
2025-01-26
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis (KOA)

Interventions

Control group:Sodium hyaluronate treatment
Low dose MSC-apoVs combined with sodium hyaluronate treatment group:Low-dose MSC-apoVs combined with sodium hyaluronate treatment
High dose MSC-apoVs combined with sodium hyaluronate treatment group:High dose MSC-apoVs combined with sodium hyaluronate therapy

Sponsors

The Second People’s Hospital of Foshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. It meets the clinical classification criteria of KOA of the American College of Rheumatology (ACR); 2. Age =18 years old, male or female; 3.18.5kg/m2= Body mass index (BMI) =35kg/m2, male weight =50kg, female weight =45kg; 4. Knee pain =20 mm as assessed by VAS (total 100 mm); 5. Voluntarily sign the subject informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe radiological knee OA with knee space stenosis of grade 3 or above as assessed by the Osteoarthritis Research Society International (OARSI) atlas; (2) Severe knee pain, the knee pain assessed by VAS (total 100 mm) =80 mm; (3) Have undergone knee surgery (arthroscopic, joint replacement, and open joint surgery) or plan to undergo knee surgery in the next 1 year; (4) A history of serious knee trauma, including arthroscopy and serious knee ligament or meniscus injury; (5) There are other types of arthritis such as rheumatoid arthritis and psoriatic arthritis; (6) Active malignant tumor or serious heart, lung, liver, kidney dysfunction; (7) Those who have a history of infection within 1 month prior to screening, require hospitalization and/or antibiotic therapy, or are currently taking systemic sex hormones (glucocorticoids), immunosuppressants, or cytotoxic therapy; (8) HIV antibody, HBsAg, HCV antibody or syphilis serological test results positive; (9) Pregnant and lactating women; (10) The investigator believes that the subjects have other conditions that are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Effectiveness evaluation index;Safety evaluation index;

Countries

China

Contacts

Public ContactChen Guoqiang

The Second People’s Hospital of Foshan

13929981788@139.com+86 757 83163839

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026