knee osteoarthritis
Conditions
Interventions
Product Name: autologous Microfat
Pharmaceutical Form: Injection
Sponsors
Clinique Juge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 20 to 65 years of age 2. Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4 3. BMI between 20 to 30 4. Written informed consent, signed by patient or legal representative (if patient unable to sign). 5. HB > 10g/dl 6. Negative pregnancy test 7. Social security affiliated Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve 2. BMI 450 G/L 5. Thrombopathy 6. TP 1,20 8. Anaemia: HB < 10g/dl 9. Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA 10. Treatment by platelet inhibiting agent, aspirin, anti vitamin K completed more than 2 weeks before inclusion 11. Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion 12. Intra articular knee injection of corticosteroid more than 8 weeks before inclusion 13. Intra articular knee injection of hyaluronic acid more than 8 weeks before inclusion 14. NSAI treatment completed more than 2 weeks before inclusion 15. Fever or recent disease 16. Auto immune disease 17. Inflammatory Arthritis 18. Immune deficit 19. Infectious disease 20. Malignant tumor being treated or history of malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months. ; Secondary Objective: Secondary objectives are to follow: • Improved chondral lesions at 3 months and 6 months on specific MRI cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping): quantitative morphological sequences resolution and qualitative structural sequences. • The evolution of the functional impact of knee osteoarthritis (WOMAC score, range of motion), compared to the initial state (scores at baseline) and the evolution of pain (VAS score) at 15 days, 1, 3 and 6 months post-injection. • The proportion of patients not responding to treatment. • The relationship between clinical efficacy and dose of PRP administered and dose of growth factors administered. ; Primary end point(s): The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months. ;Timepoint(s) of evaluation of this end point: at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives are to follow: • Improved chondral lesions at 3 months and 6 months on specific MRI cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping): quantitative morphological sequences resolution and qualitative structural sequences. • The evolution of the functional impact of knee osteoarthritis (WOMAC score, range of motion), compared to the initial state (scores at baseline) and the evolution of pain (VAS score) at 15 days, 1, 3 and 6 months post-injection. • The proportion of patients not responding to treatment. • The relationship between clinical efficacy and dose of PRP administered and dose of growth factors administered. ;Timepoint(s) of evaluation of this end point: at 15 days, 1,3 and 6 months | — |
Countries
France
Contacts
Public ContactMarie Laure LOUIS
Clinique Juge
Outcome results
None listed