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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Unknown

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

Treatments: Other: isolation of waste material and culturing with different supplement culture media

Study type: Observational

Funder types: Other

Identifiers

NCT04225481

APolLO

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

27 participants in 2 patient groups

SVF from healthy subjects from aesthetic plastic surgery

Description:

Subjects undergoing plastic surgery as scheduled by clinic routine to obtain waste adipose tissue

Treatment:

Other: isolation of waste material and culturing with different supplement culture media

OA patients

Description:

Subjects undergoing prosthetic surgery as scheduled by clinic routine to obtain waste synovium and cartilage

Treatment:

Other: isolation of waste material and culturing with different supplement culture media