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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
This is a random, open label, and parallel controled experiment. All patients are selected and sign consent forms, then divided into 3 groups. Doctors collect the basic information of patient. All patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 weeks, 1, 2, 3, 6, and 12 months after treatment, and do safety and efficacy evaluation.
Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, etc.
Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose mesenchymal stem cells | Experimental | Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) |
|
| High dose mesenchymal stem cells | Experimental | High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) |
|
| Control groups | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose mesenchymal stem cells | Biological | Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 * 10^7 cells (5ml); |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Preoperative Cartilage Defect Severity (AMADEUS) | Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS). | 12 months |
| Lysholm scoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Guo | Contact | 861064368977 | georgeguo@sclnow.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongbin Lu | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| High dose mesenchymal stem cells | Biological | Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 * 10^7 cells (5ml) |
|
| Intraarticular injection | Procedure | Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group |
|
Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.
| 12 months |
| 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. | 12 months |
| Visual Analogue Scale/Score(VAS) | Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function. | 12 months |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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