Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- Liaocheng People's Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change From Baseline in visual analogue scale (VAS)
- Last Updated
- 7 years ago
Overview
Brief Summary
Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •30-70 years old.
- •No serious infection, chronic diseases, diabetes and tuberculosis.
- •Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
- •Written informed consents were obtained from all subjects.
Exclusion Criteria
- •Pregnant women or cognitively impaired adults.
- •Inflammatory or post infectious arthritis.
- •Intra-articular drug injection within the previous 2 months.
- •Serious medical illness with a life expectancy of less than 1 year.
- •Prior admission for substance abuse.
- •Arthroscopy during the previous 6 months.
- •Systemic autoimmune rheumatic disease.
- •Poorly controlled diabetes mellitus.
- •Immunosuppressive or anticoagulant treatments.
- •Treatment with corticosteroids in the 3 months prior to inclusion in the study.
Outcomes
Primary Outcomes
Change From Baseline in visual analogue scale (VAS)
Time Frame: Baseline, 1, 3, 6 and 12 weeks
Visual analogue scale (VAS)
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
Time Frame: Baseline, 1, 3, 6 and 12 weeks
WOMAC
Change From Baseline in knee society score (KSS)
Time Frame: Baseline, 1, 3, 6 and 12 weeks
knee society score (KSS)
Change From Baseline in MOS item short from health survey(SF-36)
Time Frame: Baseline, 1, 3, 6 and 12 weeks
The MOS item short from health survey(SF-36)
Secondary Outcomes
- The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI(Baseline, 1, 3, 6 and 12 weeks)
- The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid(Baseline, 1, 3, 6 and 12 weeks)