The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease
Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3
Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance)
Age <70, no serious organ dysfunction
Over 2 years knee pain or no very effective with conservative treatments
Refuse to sign the consent form, or cannot keep follow-up visit
Age >70; Age <70, but with multiple organ failure
Unstable vital signs (breath, blood pressure, pulse)
Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc.
Parallel
Low dose mesenchymal stem cells
Biological/VaccineHuman umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 \* 10\^7 cells (5ml);
High dose mesenchymal stem cells
Biological/VaccineHuman umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 \* 10\^7 cells (5ml)
Intraarticular injection
Procedure/SurgeryIntraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Kellgren-Lawrence Grading Scale
Using Magnetic Resonance Imaging (MRI) examination, and based on the images of bilateral knee joint, grade by Kellgren-Lawrence Grading Scale. Kellgren-Lawrence Grading Scale is a method of classifying the severity of knee osteoarthritis (OA). Grade 0: No radiographic features of osteoarthritis; Grade 1: Possible joint space narrowing (normal joint space is at least 2 mm at the superior acetabulum) and osteophyte formation; Grade 2: Definite osteophyte formation with possible joint space narrowing; Grade 3: Multiple osteophytes, definite joint space narrowing, sclerosis and possible bony deformity; Grade 4: Large osteophytes, marked joint space narrowing, severe sclerosis and definite bony deformity.
Assessment of Preoperative Cartilage Defect Severity (AMADEUS)
Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS).
Lysholm scoring
Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.
The international knee documentation committee (IKDC) knee evaluation form
The international knee documentation committee knee evaluation form is used to assess the knee function of patients, examine the changes or improvement compare to baseline.
Visual Analogue Scale/Score（VAS）
Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function.
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