Safety of injecting a patient's own fat-derived stromal vascular fraction into the base of the thumb for rhizarthrosis

Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis

This trial tests whether injecting a person's own fat-derived stromal vascular fraction into the thumb joint is safe and tolerable for adults with symptomatic rhizarthrosis who have not improved after at least six months of conservative treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Drugs / interventions: methotrexate, cyclophosphamide
• Locations: 3 sites (Amiens and 2 other locations)
• Trial ID: NCT05708430 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial that uses autologous stromal vascular fraction (SVF) isolated from a participant's adipose tissue and injected into the trapeziometacarpal (base of thumb) joint. Eligible adults have stage 1–3 rhizarthrosis, persistent pain (EVA ≥4) and functional impairment (QuickDASH or PRWHE ≥20) despite ≥6 months of medical management. The procedure requires liposuction to obtain adipose tissue, processing to obtain SVF, and an intra-articular injection into the thumb joint, with follow-up to track safety and tolerability. The trial is run at university hospitals in Rouen, Amiens, and Caen in France.

Who should consider this trial

Good fit: Adults with stage 1–3 rhizarthrosis who have persistent pain (EVA ≥4) and functional limitation (QuickDASH or PRWHE ≥20) after at least six months of conservative treatment and who can safely undergo liposuction and joint injection are ideal candidates.

Not a fit: Patients with BMI <18, those who received a trapeziometacarpal injection in the past 6 months, or people with contraindications to liposuction, anesthesia, or antibiotics are unlikely to be eligible or to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could reduce pain and improve thumb function while avoiding or delaying more invasive surgical options.

How similar studies have performed: Small early-phase studies of adipose-derived stromal vascular fraction or adipose-derived stem cells in osteoarthritis have shown encouraging signals for pain and function, but evidence is limited and applications to the thumb are still relatively novel.

Eligibility criteria

Inclusion 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 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

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

Where this trial is running

Amiens and 2 other locations

• Chu Amiens — Amiens, France (Recruiting)
• Chu Caen — Caen, France (Recruiting)
• Chu Rouen — Rouen, France (Recruiting)

Study contacts

• Study coordinator: Coquerel Dorothée

Conditions Rhizarthrosis