Intra articular injection of microfat and platelet-rich plasma in the treatment of knee osteoarthritis : a pilot study

Phase 1

• Conditions: knee osteoarthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-004755-75-FR
• Lead Sponsor: Clinique Juge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-20
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified