NCT03164122

EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Recently, the emergence of biotherapies has allowed the use of intra-articular injections of autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the demonstration that platelets-enriched plasma, by virtue of its growth factors concentration, stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent literature highlights that these autologous products are very well tolerated by humans. PRP, as an intra-articular injection therapy, seems to be an autologous biological medicine, innovative for cartilage injury reparation and showing good primary results for this indication. Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to differentiate into several cellular lines in vitro and in vivo, including cartilage cells. The association of microfat and PRP is interesting in order to potentiate trophic and regenerative effects on damaged cartilage site. The combination of these two products, respectively rich in autologous multipotent stem cells and growth factors, aims to create an optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase is playing the role of a nutritive support matrix which contains and limits the diffusion and resorption of PRP liquid while allowing progressive growth factors release on the injection site. The hypothesis of this project is that standardized injection of an innovative treatment (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative second line treatment in case of medical treatment failure.

Detailed description

Material and methods: This research protocol aims to evaluate the safety of intra-articular injection of a mixture of autologous microfat associated with autologous PRP for radiocarpal osteoarthritis resistant to medical treatment. This is a prospective, longitudinal, intrasubject, single-center clinical trial phase I-IIa evaluating the safety and feasibility of this innovative treatment. Twelve patients will receive an intra-articular injection of 4 ml of an homogeneous mixture of autologous PRP (2ml) and microfat (2ml).

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	injection of microfat and plasma rich platelet PRP	intra-articular injections
DEVICE	MRI	MRI 3T

Timeline

• Start date: 2017-05-22
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2017-05-23
• Last updated: 2022-08-15

Locations

1 site across 1 country: France