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

NCT ID: NCT04225481

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-07-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SVF from healthy subjects from aesthetic plastic surgery

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

isolation of waste material and culturing with different supplement culture media

Intervention Type: OTHER

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

isolation of waste material and culturing with different supplement culture media

Intervention Type: OTHER

isolation of waste material and culturing with different supplement culture media

Interventions

isolation of waste material and culturing with different supplement culture media

isolation of waste material and culturing with different supplement culture media

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Silvia Palombella, PhD

Role: CONTACT

silvia.palombella@grupposandonato.it

02 66214061

Other Identifiers

APolLO

Identifier Type: -

Identifier Source: org_study_id