Effectiveness of Stromal Vascular Fraction (SVF) and Platelets Rich Plasma (PRP) in Osteoarthritis and Tendinopathy — SPOT  

Osteoarthritis Clinical Trial

Official title: Effectiveness of Stromal Vascular Fraction (SVF) and Platelets Rich Plasma (PRP) in Osteoarthritis and Tendinopathy: Study Protocol for a Phase III, Prospective, Randomized, Controlled Multi-center Study: (SPOT Study).

Status Not yet recruiting

Clinical Trial Summary

In a multi-centric, randomized, triple-blind controlled trial, 195 patients will be separated in 2 subgroups: 130 individuals with osteoarthritis and 65 with tendinopathies. The mian question to answer are the effect of SVF on :

• The clinical improvenent

• The cartilage thickness evolution in case of osteoarthritis

• The tendon healing in case of thendinopathy

Patients will receive an initial single PRP or PRP + SVF injection followed by one- and two-months PRP doses. In parallel, they will beneficiate of a proper rehabilitation plan with active physical therapies.

Clinical Trial Description

Background:

Osteoarthritis and tendinopathies are two frequent diseases with a high social and individual impact. Both have multifactorial etiology and the development of therapeutic options is a public health priority. Osteoarthritis is the most common joint disease, and more than 30% of sports-related injuries have a component of tendinopathy.

Most common conservative treatments for osteoarthritis treatment include painkillers, active physical therapies, orthotics, infiltrations of corticosteroids, hyaluronic acid (HA), and platelet-rich plasma (PRP).

PRP may be beneficial in both tendinopathy and osteoarthritis by interfering with catabolic and inflammatory events and by subsequently promoting anabolic responses. Activation of PRP releases biologically active components, including platelet-derived growth factor (PDGF), transforming growth factor-β (PGF-β), type I insulin-like growth factor (IGF-1) and vascular endothelial growth factor (VEGF). These proteins are responsible for a range of critical tissue healing roles such as chondrocyte and mesenchymal stem cells proliferation, bone and vessel remodeling, inflammatory modulation and collagen synthesis.

For osteoarthritis, an improvement of clinical outcomes is clearly established, presumably associated with the chondroprotective effect of PRP. Nevertheless, an in-vivo effect on human cartilage regeneration is not yet demonstrated despite the numerous studies approaching the subject.

Most common conservative treatments for tendinopathies include painkillers, bracing, active physical therapies, extracorporeal shockwave therapy, other specific therapies (cryotherapy, red light therapy, topical glycerol trinitrate, PRP and tendon lengthening. Clear clinical benefits are currently demonstrated with active exercises and extracorporeal shockwave therapies. Tendon needling, also known as tendon fenestration or percutaneous needle tenotomy, intends to disrupt the chronic inflammatory and degenerative processes through localized bleeding, fibroblastic proliferation, and organized collagen synthesis. The intervened tendon can also lengthen in some cases.

Preclinical models elucidated how injected Adipose Derived- Mesenchymal Stem Cells (AD-MSC) coordinate the cartilage regeneration process through paracrine mechanisms, producing cytokines and trophic bioactive factors that stimulate cellular proliferation, reduce inflammation, fibrosis, oxidative stress, and chondrocytes senescence.

Stromal Vascular Fraction (SVF), a product from specific adipose tissue processing, contains mesenchymal stem cells, endothelial precursor cells, T regulatory cells, macrophages, smooth muscle cells, pericytes and preadipocytes. SVF extraction and injection techniques have been recently used as an alternative to harvest AD-MSC due to its logistic simplicity and feasibility in clinical practice.

SVF injections produce a clinically significant effect on the treatment of knee osteoarthritis, and a possible improvement in cartilage quality. Promising results were observed in the Achilles tendon.

This clinical trial aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration on osteoarthritis and tendinopathies. ;

Related Conditions & MeSH terms

• Osteoarthritis
• Tendinopathy

• NCT number: NCT05660824
• Study type: Interventional
• Source: Hôpital de la Providence, Switzerland
• Contact: Adrien Schwitzguébel, MD.
• Phone: +41 79 762 05 62
• Email: adrien.schwitzguebel@gmail.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2023
• Completion date: June 2025