Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.

Detailed Description
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Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

Official Title
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Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Mesenchymal stem cells low-dose group
* Biological: Mesenchymal stem cells mid-dose group
* Biological: Mesenchymal stem cells high-dose group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who understand and sign the consent form for this study. Age: 40-70, males and females. Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence. Patients who can't treat with traditional medication and need a arthroplasty. Duration of pain over Grade 4(11-point numeric scale)> 4 months. Exclusion Criteria: Women who are pregnant or breast feeding or planning to become pregnant during the study. Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study. History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications. Treatment with intra-articular injection therapy within 2 months prior to screen. Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis. Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis. Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus. Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II). Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cells low-dose group<br>Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks. | Biological: Mesenchymal stem cells low-dose group<br>* Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use<br>* Other names: Adipose tissue derived mesenchymal stem cells;|
| Experimental: Mesenchymal stem cells mid-dose group<br>Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks. | Biological: Mesenchymal stem cells mid-dose group<br>* Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use<br>* Other names: Adipose tissue derived mesenchymal stem cells;|
| Experimental: Mesenchymal stem cells high-dose group<br>Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks. | Biological: Mesenchymal stem cells high-dose group<br>* Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use<br>* Other names: Adipose tissue derived mesenchymal stem cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of Adverse Events and Serious Adverse Events |  | 12 weeks | 
| Electrocardiogram |  | 9 weeks | 
| Vital signs |  | 9 weeks | 
| Physical examination |  | 9 weeks | 
| WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) |  | 24 months | 
| Laboratory tests | Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 |  | 24 months | 
| NRS-11 |  | 24 months | 
| The volume of articular cartilage |  | 24 months |