Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis (OA), mesenchymal stem cells(MSC)
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.
Interventions
BIOLOGICALUmbilical-cord mesenchymal stromal cells (UC-MSCs)
Allogeneic UC-MSCs 1 x 10\ 7 diluted on 5 mL of Platelet Rich Plasma
OTHERHyaluronic acid
intra-articular injection of Hyaluronic Acid
Sponsors
Liaocheng People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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. * NSAID therapy within 15 days prior to inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in visual analogue scale (VAS) | Baseline, 1, 3, 6 and 12 weeks | Visual analogue scale (VAS) |
| Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score | Baseline, 1, 3, 6 and 12 weeks | WOMAC |
| Change From Baseline in knee society score (KSS) | Baseline, 1, 3, 6 and 12 weeks | knee society score (KSS) |
| Change From Baseline in MOS item short from health survey(SF-36) | Baseline, 1, 3, 6 and 12 weeks | The MOS item short from health survey(SF-36) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid |
Countries
China
Contacts
Primary ContactChanghui Zhou, Ph.D.
Outcome results
None listed