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New treatment option for Rhizarthrosis
Official title Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
ClinicalTrials.gov ID: NCT05708430
What this study is testing
What is SVF injection into wrist?
SVF injection into wrist is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for rhizarthrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rhizarthosis is a common disease in the population (15%). It has a major impact on the function of the hand since it compromises the pollicidigitales claws and all gripping functions with the thumb.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
- 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…
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Caen, France
- Rouen, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Caen, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.