Low dose mesenchymal stem cells: Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 \* 10\^7 cells (5ml);
High dose mesenchymal stem cells: Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 \* 10\^7 cells (5ml)
Intraarticular injection: Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Study summary
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
Eligibility
Sex
ALL
Min age
—
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Knee pain of VAS (visual analog scale score) is 4 or higher
* Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc.
* Understand and sign the consent form of this study
Exclusion Criteria:
* 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.
* Serious bleeding tendency, poor coagulation function (PTA \<35%)
* Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment
* Participate other clinical experiments in 3 months
* With progressing malignant tumor
* Combined with shock and critically ill patients
* With mental disease, cannot
* With history of knee joint infection, surgery, and radiotherapy
* With immunosuppressive agents treatment in 6 weeks
* Injection with hormones and sodium hyaluronate in joint in 3 months
* Overweight expressed as body mass index (BMI) \>35
* With skin disease around knee joint
* With Immunodeficiency disease, including long term use immunosuppressive agents patients
* Combined with serious infection
* With some other conditions that doctor propose not to participate
Primary outcome measure(s)
Kellgren-Lawrence Grading Scale — 12 months 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.
Trial sites (1)
Facility
City
Region
Status
Xiangya Hospital Central South University
Changsha
Hunan
Recruiting
More Sclnow Biotechnology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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