Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

Phase 1

• Conditions: Osteoarthritis of the Knee
• Interventions: Other: Hyaluronic acid; Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)

• Registration Number: NCT03166865
• Lead Sponsor: Liaocheng People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-04
• Study Start: 2018-10-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Hyaluronic acid	Intraarticular injection of hyaluronic acid
Intervention group	Umbilical-cord mesenchymal stromal cells (UC-MSCs)	Intraarticular injection of 2×10\~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Liaocheng city people's hospital; 🇨🇳 Liaocheng, Shandong, China