Marie Laure Louis1, Robinson Gravier Dumonceau2, Elisabeth Jouve2, Michel Cohen3, Rym Djouri4, Nathalie Richardet5, Emmanuelle Jourdan6, Laurent Giraudo7, Chloe Dumoulin7, Fanny Grimaud7, Francoise Dignat George8, Julie Veran7, Florence Sabatier9, Jeremy Magalon10. 1. ICOS, Sport and Orthopedics Surgery Institute, Marseille, France; Orthopedic Department, Clinique Juge, Almaviva, Marseille, France; Orthopedic Department, Hopital Nord, AP-HM, Marseille, France. 2. Pharmacometry, CIC-CPCET, Clinical Pharmacology and Pharmacovigilance Department, Hôpital de la Timone, AP-HM, Marseille, France. 3. Radiology Department, Clinique Juge, Almaviva, Marseille, France. 4. Siemens Healthineers, Saint Denis, France. 5. ICOS, Sport and Orthopedics Surgery Institute, Marseille, France; Orthopedic Department, Clinique Juge, Almaviva, Marseille, France. 6. Pharmacy Department, Clinique Juge, Almaviva, Marseille, France. 7. Cell Therapy Laboratory, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, Marseille, France. 8. Hematology and Vascular Biology Department, Hôpital de la Conception, AP-HM, Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. 9. Cell Therapy Laboratory, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. 10. Cell Therapy Laboratory, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France. Electronic address: jeremy.magalon@ap-hm.fr.
Abstract
PURPOSE: Compare a single abdominal microfat (MF) injection mixed or not with PRP Low Dose (LD) or High Dose (HD) in order to improve MRI parameters and alleviate pain and enhance functional capacity in knee osteoarthritis (OA). METHODS:Patients with symptomatic grade 2 to 4 knee OA according to the International Cartilage Repair Society MRI classification were selected. They were prospectively assessed at baseline, at 3 and 6 months of follow-up. The primary endpoint was the change in maximum of value of cartilage relaxation time in T2 mapping sequences (T2max) at 3 months. Secondary endpoints were MRI grade severity and joint space assessment, WOMAC score, pain evaluation, knee range of motion and patient's satisfaction. Adverse events were also collected. The complete cell counts and growth factors content of injected products were assessed to analyze their potential relationship with MRI/clinical outcomes. RESULTS: Three groups of 10 patients received a single injection of 10 cc of a mix (1:1) containing either MF-Saline, MF-PRP LD or MF-PRP HD. T2max did not change significantly over the time for any of the groups. All treatments significantly improved knee functional status and symptoms relief at 3 and 6 months. All patients were responders in the MF/PRP HD at 3 months and significantly higher compared to MF/PRP LD. Half of the injected PRP in the MF/PRP LD group displayed RBCs contamination over 8% which was correlated with an impairment of T2max. CONCLUSION: A single intra articular injection of MF with or without PRP is safe and may offer a significant clinical improvement in patients with OA.
RCT Entities:
PURPOSE: Compare a single abdominal microfat (MF) injection mixed or not with PRP Low Dose (LD) or High Dose (HD) in order to improve MRI parameters and alleviate pain and enhance functional capacity in knee osteoarthritis (OA). METHODS:Patients with symptomatic grade 2 to 4 knee OA according to the International Cartilage Repair Society MRI classification were selected. They were prospectively assessed at baseline, at 3 and 6 months of follow-up. The primary endpoint was the change in maximum of value of cartilage relaxation time in T2 mapping sequences (T2max) at 3 months. Secondary endpoints were MRI grade severity and joint space assessment, WOMAC score, pain evaluation, knee range of motion and patient's satisfaction. Adverse events were also collected. The complete cell counts and growth factors content of injected products were assessed to analyze their potential relationship with MRI/clinical outcomes. RESULTS: Three groups of 10 patients received a single injection of 10 cc of a mix (1:1) containing either MF-Saline, MF-PRP LD or MF-PRPHD. T2max did not change significantly over the time for any of the groups. All treatments significantly improved knee functional status and symptoms relief at 3 and 6 months. All patients were responders in the MF/PRPHD at 3 months and significantly higher compared to MF/PRP LD. Half of the injected PRP in the MF/PRP LD group displayed RBCs contamination over 8% which was correlated with an impairment of T2max. CONCLUSION: A single intra articular injection of MF with or without PRP is safe and may offer a significant clinical improvement in patients with OA.
Authors: Nima Heidari; Mark Slevin; Yasmin Zeinolabediny; Davide Meloni; Stefano Olgiati; Adrian Wilson; Ali Noorani; Leonard Azamfirei Journal: J Clin Med Date: 2022-02-17 Impact factor: 4.241