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

Liaocheng People's Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Osteoarthritis of the Knee

Treatments: Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs); Other: Hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03166865

lcsrmyygk

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intraarticular injection of 2×10\~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)

Treatment:

Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)

Control group

Other group

Description:

Intraarticular injection of hyaluronic acid

Treatment:

Other: Hyaluronic acid