Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.

Official Title
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Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells

Conditions
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Osteoarthritis Knee

Intervention / Treatment
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* Drug: Adipose-Derived Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray. Subject's pain score is 8-13 points (Lequesne's index). Ages between 50-70 years. Signed informed consent from the subject. Female subjects should be post-menopausal women Exclusion Criteria: Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV. Subject not suitable for liposuction surgery. Subject with hypersensitivity/allergy to anesthetic. Subject's creatinine values higher than 1.6mg/dl. Subject with body mass index, BMI over 30. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. Subject enrolled in any other cell therapy studies within the past 30 days. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Ages Eligible for Study
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Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADMSCs<br>Three intra-articular injections of ADMSCs at the dose of 8 10x10^6 cells/injection | Drug: Adipose-Derived Mesenchymal Stem Cells<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment of visual analogue scale (VAS) |  | 12 months | 
| Clinical assessment of Short Form 36 questionnaire (SF-36) |  | 12 months | 
| Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC) |  | 12 months | 
| Clinical assessment of Hospital for Special Surgery (HSS) Knee Score |  | 12 months | 
| Clinical imaging assessment of knee X-ray |  | 12 months | 
| Clinical imaging assessment of MRI of the knee |  | 12 months |