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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 27

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy subjects undergoing aesthetic plastic surgery or OA patients undergoing prosthetic surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SVF from healthy subjects from aesthetic plastic surgery; 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; isolation of waste material and culturing with different supplement culture media
OA patients; 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; isolation of waste material and culturing with different supplement culture media

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: APOLLO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No