The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid

Study Overview
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Brief Summary
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The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).

Detailed Description
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This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.

Official Title
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The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Mesenchymal Stem Cells from adipose
* Biological: Hyaluronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: K / L score of 2-3; chronic knee pain; no local or systemic infection; without obvious contraindication of the joint puncture from hematology and biochemical tests; informed consent. Exclusion Criteria: older than 75 years old or less than 18 years old, or without full capacity for civil conduct; HIV, hepatitis virus or syphilis virus infection or their serology is positive; BMI index is greater than 30; congenital or acquired knee deformity; pregnant or lactating women; tumor patients; immunodeficiency patients; intra-articular drug injection history within 3 months; participating in other clinical trials; other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal Stem Cells from adipose<br>Mesenchymal Stem Cells from adipose will be injected. | Biological: Mesenchymal Stem Cells from adipose<br>* inject mesenchymal Stem Cells from adipose<br>|
| Active Comparator: hyaluronic acid<br>Hyaluronic acid will be injectied. | Biological: Hyaluronic Acid<br>* inject hyaluronic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unexplained local and systemic symptoms or death | The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | VAS score decrease 3 points or more | 2 years | 
| WOMAC score | two or more terms of WOMAC score have improvement. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis, adipose, mesenchymal stem cells