Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis

Study Overview
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Brief Summary
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Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.

Official Title
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Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis

Conditions
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Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL

Intervention / Treatment
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* Other: isolation of waste material and culturing with different supplement culture media


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OA patients Subscription of informed consent BMI < 30 age between 55-75 years included Kelgrenn-Lawrence equal or superior to grade III presence of synovitis patients undergoing knee replacement suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Healthy subjects from aesthetic plastic surgery Subscription of informed consent BMI < 30 age between 18-50 years included subjects undergoing liposuction and/or abdominoplasty Exclusion Criteria: HCV, HIV, HBV, TPHA infection Pregnancy (auto declaration)

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SVF from healthy subjects from aesthetic plastic surgery<br>Subjects undergoing plastic surgery as scheduled by clinic routine to obtain waste adipose tissue | Other: isolation of waste material and culturing with different supplement culture media<br>* isolation of waste material and culturing with different supplement culture media<br>|
| OA patients<br>Subjects undergoing prosthetic surgery as scheduled by clinic routine to obtain waste synovium and cartilage | Other: isolation of waste material and culturing with different supplement culture media<br>* isolation of waste material and culturing with different supplement culture media<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL | With this project, we expect to demonstrate that HPL increases the beneficial properties of SVF on cartilage regeneration and joint environment. We envision that HPL will increase expression of genes involved in ECM synthesis, thus enhancing cartilage regeneration. Based on previous published data, we will consider as statistical a difference between treated (SVF + HPL) and not treated samples (SVF) of two folds in expression of genes involved in ECM production (e.g. COL2A1, ACAN, SOX9). A fold increase equal to 2 is the minimum value to consider biologically relevant the influence of the treatment compared to a control group in which the gene expression is considered to be equal to 1. If our hypothesis will be confirmed, this will allow to improve the current therapy for OA with a biological adjuvant that reduces disease progression and helps cartilage regeneration. | surgery as scheduled by clinic routine |