Adults with a rhizarthrosis stage DELL 1 to 3
Conditions
Interventions
Trade Name: Advanced Therapy Medicinal Products (ATMPs) punctually prepared (PP) : Autologous Stromal Vascular Fraction
Product Name: Autologous Stromal Vascular Fraction
Product Code: Autologous Str
Sponsors
Direction de la Recherche Clinique et de l'Innovation - CHU de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult (= 18 years old) • Rhizarthrosis DELL stage 1 to 3 • 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 • Affiliation to a social security scheme • Person who has read and understood the information letter and signed the consent form • For women : o Woman of childbearing age with effective contraception (Cf. CTFG) (oestrogen-progestins or intrauterine device or tubal ligation) for 3 months and a negative urine pregnancy test on inclusion (V1) o Postmenopausal woman: non-medically induced amenorrhea for at least 12 months before the inclusion visit 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months • Body Mass Index 10 mg/day, methotrexate > 25 mg/week, mycofenolate mofetil > 3 grams/day, azathioprine > 200 mg/day and intravenous cyclophosphamide and any biotherapy within 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 • Pregnant woman or woman likely to be in the absence of effective contraception (Women of childbearing age must have a negative urine pregnancy test on inclusion) • Breastfeeding woman or absence of proven contraception • Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship • Person taking part in the research participating in another trial / having participated in another trial within 6 months • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for his participation in the protocol or preventing him from giving his informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the research is to assess the tolerance at 6 months of intra-articular injection of FVS for the treatment of rhizarthosis. ;Secondary Objective: The secondary objectives of the research are to assess at 1, 3 and 6 months: - the efficacy of intra-articular injection of FVS on (1) functional level and on (2) pain, - (3) cartilage regeneration after intra-articular injection of FVS.;Primary end point(s): The primary endpoint is the number of treatment-attributable Grade = 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS.;Timepoint(s) of evaluation of this end point: within 6 month period post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are to assess at 1, 3 and 6 months: • (1) Functional assessment of the hand: o Kapandji score o JAMAR and Key pinch o Active mobility of the trapezio-metacarpal in antepulsion and abduction o Grinding test o DASH and PWRHE quick score • (2) Evaluation of pain by the EVA scale and by monitoring the progress of long-term analgesic treatment • (3) Assessment of cartilage regeneration o Evaluation by MRI of the cartilage: - Evaluation of intra-articular inflammation of the trapezio-metacarpal - Control of peri-articular inflammatory areas (in particular the flexor carpi radialis or the scapho-trapezio-trapezoid) - Assessment of cartilage thickness - Significance of TM subluxation o X-ray of the trapezio-metacarpal (Kapandji views): - Evaluation of the thickness of the articular line of the trapezio-metacarpal - Appearance or regression of signs of osteoarthritis (geode, condensation, osteophyte) - Trapezio-metacarpal deformity (DELL classification, Appendix 1) - Significance of TM subluxation;Timepoint(s) of evaluation of this end point: At 1, 3 and 6 months post-surgery | — |
Countries
France
Contacts
Public ContactDavid MALLEt
Direction de la Recherche Clinique et de l'Innovation - CHU de Rouen
Outcome results
None listed