Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis (FVS-RHIZA)
Rhizarthrosis
About this trial
This is an interventional treatment trial for Rhizarthrosis
Eligibility Criteria
Inclusion Criteria: Rhizarthrosis DELL stage 1 to 3 (see appendix 1) Symptomatic medical treatment for a period of at least 6 months (analgesic, orthosis, anti-inflammatory, etc. or intra-articular infiltration of the trapezio-metacarpal joint) which has become ineffective (surgical stage) EVA pain ≥ 4 Quick Dash or PRWHE ≥ 20/100 (see Appendices 2 and 3) Affiliation to a social security scheme Person who has read and understood the information letter and signed the consent form Exclusion Criteria: History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months Body Mass Index < 18 kg/m2 Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist) Contraindication to liposuction (eg bleeding disorder) Documented severe allergy to conventional antibiotics such as β-lactams, cyclins, macrolides, quinolones, aminoglycosides, etc… Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion) A general or local infection near the sampling or injection sites Any surgery scheduled over the duration of the study of the hand (carpal tunnel type operation) or upper limb that may have an impact on the assessment of pain and/or functional indices Persons on immunosuppressants: corticosteroid therapy > 10 mg/d, methotrexate > 25 mg/week, mycofenolate mofetil > 3 grams/d, azathioprine > 200 mg/d and intravenous cyclophosphamide and any biotherapy in the 90 days preceding the medical visit. inclusion Congenital or acquired immune deficiency Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion Persons infected with HIV, HCV, HBV, HTLV and syphilis Contraindication to MRI, (eg, due to presence of pacemakers or other incompatible foreign material or claustrophobia) Contraindication to the injection of gadolinated contrast product (gadolinium) for performing MRI (history of hypersensitivity to gadolinated contrast products) Active COVID-19 infection (PCR positive) Any cardiovascular, metabolic, endocrine, psychiatric or cancerous pathology in uncontrolled evolution
Sites / Locations
Arms of the Study
Arm 1
Experimental
SVF injection
Intra-articular injection of autologous cells from the stromal vascular fraction derived from adipose tissue