AUTOLOGOUS ADIPOSE TISSUE-DERIVED STROMAL VASCULAR FRACTION for Thumb carpometacarpal osteoarthritis (rhizarthrosis)

Inclusion criteria

• {"criterion_text":"- Adult (≥ 18 years old)"}
• {"criterion_text":"- Rhizarthrosis DELL stage 1 to 3"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- EVA pain ≥ 4"}
• {"criterion_text":"- Quick Dash or PRWHE ≥ 20/100"}
• {"criterion_text":"- Affiliation to a social security scheme"}
• {"criterion_text":"- Person who has read and understood the information letter and signed the consent form"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- For men: Surgical sterility, or mechanical contraception (condom) for the duration of the study, or with a partner of childbearing age taking effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) for at least 3 months at inclusion and for the duration of the study, or with a postmenopausal partner: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)."}

Exclusion criteria

• {"criterion_text":"- History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months"}
• {"criterion_text":"- Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship"}
• {"criterion_text":"- Person taking part in the research participating in another trial / having participated in another trial within 6 months"}
• {"criterion_text":"- Body Mass Index < 18 kg/m2"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection"}
• {"criterion_text":"- Contraindication to liposuction (eg bleeding disorder)"}
• {"criterion_text":"- Documented severe allergy to conventional antibiotics such as β- lactams, cyclins, macrolides, quinolones, aminoglycosides, etc…"}
• {"criterion_text":"- A general or local infection near the sampling or injection sites"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Persons on immunosuppressants: corticosteroid therapy > 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"}
• {"criterion_text":"- Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion"}
• {"criterion_text":"- Congenital or acquired immune deficiency"}
• {"criterion_text":"- Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion)"}
• {"criterion_text":"- Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)"}
• {"criterion_text":"- Persons infected with HIV, HCV, HBV, HTLV I and syphilis"}
• {"criterion_text":"- Contraindication to MRI, (eg, due to presence of pacemakers or other incompatible foreign material or claustrophobia)"}
• {"criterion_text":"- Contraindication to the injection of gadolinated contrast product (gadolinium) for performing MRI (history of hypersensitivity to gadolinated contrast products)"}
• {"criterion_text":"- Active COVID-19 infection (PCR positive)"}
• {"criterion_text":"- Any cardiovascular, metabolic, endocrine, psychiatric or cancerous pathology in uncontrolled evolution"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Breastfeeding woman or absence of proven contraception"}

Primary endpoints

• {"endpoint_text":"- The number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS","definition_or_measurement_approach":"Count of treatment-attributable Grade ≥ 3 adverse reactions occurring during the 6-month period after the intra-articular injection of FVS"}

Secondary endpoints

• {"endpoint_text":"- Assess at 1, 3 and 6 months functional assessment of the hand (Kapandji score, JAMAR and Key pinch, Active mobility of the trapezio-metacarpal in antepulsion and abduction, Grinding test, DASH and PWRHE quick score)","definition_or_measurement_approach":"Functional assessment at 1, 3 and 6 months using Kapandji score, JAMAR and Key pinch, active mobility measures, Grinding test, QuickDASH and PWRHE scores"}
• {"endpoint_text":"- Assess at 1, 3 and 6 months the pain by the EVA scale and by monitoring the progress of long-term analgesic treatment","definition_or_measurement_approach":"Pain measured at 1, 3 and 6 months by EVA (visual analog scale) and by monitoring changes in long-term analgesic therapy"}
• {"endpoint_text":"- Assess at 1, 3 and 6 months cartilage regeneration (Evaluation by MRI of the cartilage and X-ray of the trapezio-metacarpal","definition_or_measurement_approach":"Cartilage regeneration evaluated at 1, 3 and 6 months by MRI assessment of cartilage and radiography of the trapezio-metacarpal joint"}
• {"endpoint_text":"- Assessment of adverse events using EvI/EvIG data collection","definition_or_measurement_approach":"Adverse events collected and assessed using EvI/EvIG data collection processes"}

France

Earliest CTIS Part Ii Submission Date

17-06-2024

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

618

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France