Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL Clinical Trial
Official title:
Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis
| NCT number | NCT04225481 |
| Other study ID # | APolLO |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2020 |
| Est. completion date | July 2022 |
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.
| Status | Not yet recruiting |
| Enrollment | 27 |
| Est. completion date | July 2022 |
| Est. primary completion date | July 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Ortopedico Galeazzi |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |