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Tolerance of intra-articular injection of autologous stromal vascular fraction for the treatment of rhizarthrosis_FVS-RHIZA
EU CTIS ID: 2024-515317-18-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months
- 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
- Body Mass Index < 18 kg/m2
- 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
- Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection
See the full eligibility criteria
Who can join
- 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
- 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
- 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).
What rules you out
- History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months
- 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
- Body Mass Index < 18 kg/m2
- 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
- Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection
- Contraindication to liposuction (eg bleeding disorder)
- Documented severe allergy to conventional antibiotics such as β- lactams, cyclins, macrolides, quinolones, aminoglycosides, etc…
- 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/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
- Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion
- Congenital or acquired immune deficiency
- Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion)
- Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)
- Persons infected with HIV, HCV, HBV, HTLV I 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.