EUCTR2016-004755-75-FR
Active, not recruiting
Phase 1
Intra articular injection of microfat and platelet-rich plasma in the treatment of knee osteoarthritis : a pilot study - MICROPREP
Clinique Juge0 sites30 target enrollmentFebruary 20, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Clinique Juge
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
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
Outcomes
Primary Outcomes
Not specified
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