E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal exclusion criteria |
1. IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve 2. BMI < 20 3. Thrombocytopenia < 150 G/L 4. Thrombocytosis > 450 G/L 5. Thrombopathy 6. TP < 70% 7. TCA patient / witness rapport > 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at 15 days, 1,3 and 6 months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |