Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results

Alice Mayoly (1) , Aurelie Iniesta (1) , Caroline Curvale (1) , Najib Kachouh (2) , Charlotte Jaloux (2) , Julia Eraud (3) , Marie Vogtensperger (4) , Julie Veran (5) , Fanny Grimaud (3) , Elisabeth Jouve (1, 6) , Dominique Casanova (3) , Florence Sabatier (3, 7) , Regis Legre (8, 3) , Jeremy Magalon (7, 3)

1 TIMONE - Hôpital de la Timone [CHU - APHM]
2 AMU MED - Aix-Marseille Université - Faculté de médecine
3 LA CONCEPTION - Hôpital de la Conception [CHU - APHM]
4 APHM - Assistance Publique - Hôpitaux de Marseille
5 CIC - Biotherapie - Marseille
6 AMU - Aix Marseille Université
7 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
8 Service de chirurgie de la main, chirurgie plastique et réparatrice des membres

Wrist osteoarthritis (OA) is one of the most common conditions encountered by hand surgeons with limited efficacy of non-surgical treatments. The purpose of this study is to describe the Platelet-Rich Plasma (PRP) mixed-microfat biological characteristics of an experimental Advanced Therapy Medicinal Product (ATMP) needed for clinical trial authorization and describe the clinical results obtained from our first three patients 12 months after treatment (NCT03164122). Biological characterization of microfat, PRP and mixture were analysed in vitro according to validated methods. Patients with stage four OA according to the Kellgren Lawrence classification, with failure to conservative treatment and a persistent daily painful condition >40 mm according to the visual analog scale (VAS) were treated. Microfat-PRP ATMP is a product with high platelet purity, conserved viability of stromal vascular fraction cells, chondrogenic differentiation capacity in vitro and high secretion of IL-1Ra anti-inflammatory cytokine. For patients, the only side effect was pain at the adipose tissue harvesting sites. Potential efficacy was observed with a pain decrease of over 50% (per VAS score) and the achievement of minimal clinically important differences for DASH and PRWE functional scores at one year in all three patients. Microfat-PRP ATMP presented a good safety profile after an injection in wrist OA. Efficacy trials are necessary to assess whether this innovative strategy could delay the necessity to perform non-conservative surgery.

Mots clés: cell therapy; adipose tissue; platelet-rich plasma; wrist osteoarthritis; microfat

Domaines: Sciences du Vivant [q-bio]

Alice Mayoly, Aurelie Iniesta, Caroline Curvale, Najib Kachouh, Charlotte Jaloux, et al.. Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results. International Journal of Molecular Sciences, 2019, 20 (5), pp.1111. ⟨10.3390/ijms20051111⟩. ⟨hal-02555854⟩