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

• Conditions: Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL
• Interventions: Other: isolation of waste material and culturing with different supplement culture media

• Registration Number: NCT04225481
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2021-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SVF from healthy subjects from aesthetic plastic surgery	isolation of waste material and culturing with different supplement culture media	Subjects undergoing plastic surgery as scheduled by clinic routine to obtain waste adipose tissue
OA patients	isolation of waste material and culturing with different supplement culture media	Subjects undergoing prosthetic surgery as scheduled by clinic routine to obtain waste synovium and cartilage

Primary Outcome Measures

Name	Time	Method
Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL	surgery as scheduled by clinic routine	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.