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To evaluate the efficacy of human umbilical cord mesenchymal stem cells injected into articular cavity in the treatment of knee osteoarthritis

To evaluate the efficacy of human umbilical cord mesenchymal stem cells injected into articular cavity in the treatment of knee osteoarthritis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076834
Enrollment
Unknown
Registered
2023-10-20
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Knee osteoarthritis

Interventions

Experimental group:Mesenchymal stem cells and sodium hyaluronate were injected into the knee cavity
Control group:Sodium hyaluronate was injected into the knee cavity

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) patients with primary knee osteoarthritis aged 45-70 years; (2) Patients who had received NSAIDS and physical therapy regularly for 6 weeks and had no improvement in knee pain VAS score or knee function KSS score; Or regular non-steroidal anti-inflammatory drugs and physical therapy for more than 6 weeks within a year, knee pain VAS score of more than 3 times in a year more than 4 points; (3) The patient met the X-ray KL classification of both knee joints = level 2, and the classification of both knee joints was consistent; (4) The difference in VAS scores for pain of both knees was no more than 2 points; (5) Coagulation function: D-dimer quantification (DD) < 255 ng/mL, plasma prothrombin time (PT) 8.8-13.4 S, prothrombin activity (PTA) 70-160%, thrombin time (TT) 11.0-17.8 S, activated partial thrombin time (APTT) 23.3-38.1 S; (6) Erythrocyte sedimentation rate 0-20 mm/h, CRP< 0.8 mg/dl; (7) Blood routine: red blood cells 3.8-5.8×10^12 /L, hemoglobin 115-175 g/L, white blood cells 3.5-9.5×10^9 /L, platelet count 125-350×10^9 /L, neutrophil percentage 40-75%.

Exclusion criteria

Exclusion criteria: (1) Patients who had received intra-articular injection therapy within 3 months; (2) KL grade of knee imaging X-rays > Grade 2; (3) Had a knee infection within 12 weeks, or had a knee injury within 12 weeks; (4) Rheumatoid arthritis and other autoimmune arthritis; (5) Patients with gastrointestinal ulcer, coronary heart disease and other contraindications to use NSAIDS; (6) Patients with tumor, diabetes, blood system diseases, local skin diseases and systemic allergies; (7) Patients with immunodeficiency or who have received immunosuppressive therapy within 12 weeks; (8) Received anticoagulation or anticoagulation therapy within 4 weeks; (9) Patients with other serious diseases who could not cooperate with the study.

Design outcomes

Primary

MeasureTime frame
Short-term security;Clinical score;Image score;

Countries

China

Contacts

Public ContactMa Jie; Chen Min; Xue Qingyun

Beijing Hospital

liucxmm@126.com+86 85133661

Outcome results

None listed

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