EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA”

Phase 1

• Conditions: Symptomatic radio-carpal osteoarthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002648-18-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-25
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

-Males and females between 20 and 75 years of age
-Symptomatic radio-carpal osteoarthritis diagnosed by arthroscanner resistant to medical treatment and candidate to surgery
-BMI = 20 Kg/m²
-Written informed consent, signed by patient or legal representative (if patient unable to sign).
-HB > 10g/dl
-Negative pregnancy test and efficiency contraception

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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

-Thrombocytopenia < 150 G/L, Thrombocytosis > 450 G/L, Thrombopathy
-TP < 70%, TCA patient / witness rapport > 1,20
-Anemia: HB < 10g/dl
-Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
-Treatment by platelet inhibiting agent, aspirin, antivitamin K completed more than 2 weeks before inclusion
-Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
-Intra articular injection of corticosteroid or hyaluronic acid completed more than 8 weeks before inclusion
-NSAI treatment completed more than 2 weeks before inclusion
-Fever or recent disease completed more than 1 month before inclusion
-Auto immune disease, Inflammatory or microcrystalline Arthritis, Immune deficit
-Infectious disease
-IRM contraindication: ocular loose bodies, pace maker, neurostimulator, cochlear implant, vascular clips, metallic cardiac val
-Anesthesia or surgery contra indication, iodine allergy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the safety at 1 month of intra-articular injection of microfat associated with PRP in the radio-carpal joint of patients with radiocarpal osteoarthritis.;Secondary Objective: Evaluate the following efficiency criteria:<br><br>at 3,6, 12 months : <br>-Improvement of pain with the Visual Analogue Scale (VAS). <br>-Improvement of wrist pain and function with DASH and PWRE scores.<br>-Improvement of wrist range of motion<br>-Improvement of Jamar strength test<br>-Patient satisfaction<br><br>at 12 months : <br>-Improvement of radiocarpal chondral lesions on specific MRI sequences <br>;Primary end point(s): tolerance assessed by the occurrence of adverse events up to one month post administration related to study treatments according to their origin :<br>- Related AEs adipose tissue removal<br>- AE related to the production of PRP and preparation of micrograisse<br>- AE related to intra-articular injection;Timepoint(s) of evaluation of this end point: 1 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Pain assessment<br>-Assessment of wrist strength by dynamometry;Timepoint(s) of evaluation of this end point: 12 months