Actively Recruiting
Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
Led by University Hospital, Rouen · Updated on 2026-02-17
12
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Rhizarthrosis is a common condition affecting about 15% of the population, impacting hand function by limiting thumb movement and gripping ability. Current treatments focus on easing symptoms with pain relievers, anti-inflammatory drugs, braces, or injections, but none cure the disease. Surgery is considered when symptoms worsen, though it may cause stiffness, risk of dislocation, or long recovery, so researchers are exploring less invasive options. This Phase 2 study evaluates a potential new approach using stem cell-based therapy derived from a person's own fat tissue. The study is testing an injection of autologous stromal vascular fraction (SVF) cells from fat tissue into the trapezio-metacarpal joint for people with rhizarthrosis who have not found relief from standard treatments and are considering surgery. The cells are collected through liposuction and processed by centrifugation before being injected into the joint. This injection is thought to have properties that may reduce inflammation and promote cartilage repair, aiming to offer a less invasive alternative to surgery. Participants will be monitored for safety, with the main focus on any serious adverse reactions occurring in the six months following the injection. Assessments include pain levels, hand function scores, and clinical evaluations. The trial involves a single treatment phase with follow-up visits to track effects and potential side effects. The total study duration includes this 6-month period after the injection to assess tolerance and safety.
CONDITIONS
Brief Title
Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with rhizarthrosis DELL stage 1 to 3
- Have received symptomatic medical treatment for at least 6 months that has become ineffective
- Pain level of 4 or higher on the EVA pain scale
- QuickDASH or PRWHE score of 20 or higher out of 100
- Affiliated to a social security scheme
- Have read and understood the information letter and signed the consent form
You will not qualify if you...
- Received intra-articular injection in the trapezio-metacarpal joint within the last 6 months
- Body mass index less than 18 kg/m2
- Contraindications to general or local anesthetics including specific solutions
- Contraindications to sedation or general anesthesia
- Contraindications to liposuction (e.g., bleeding disorders)
- Severe allergy to certain antibiotics
- Known hypersensitivity to human albumin or excipients
- Active infection near sampling or injection sites
- Scheduled hand or upper limb surgery that affects pain or function assessment
- Use of high-dose immunosuppressants or biotherapy in the 90 days before inclusion
- Congenital or acquired immune deficiency
- New systemic treatments affecting hand condition started in last 90 days
- Infection with HIV, HCV, HBV, HTLV, or syphilis
- Contraindications to MRI or gadolinium contrast
- Active COVID-19 infection
- Uncontrolled cardiovascular, metabolic, endocrine, psychiatric, or cancerous disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive an intra-articular injection of autologous cells derived from the stromal vascular fraction into the wrist to treat rhizarthrosis.
Follow-up visits over 6 months to monitor treatment-attributable adverse reactions
Trial Site Locations
Total: 3 locations
1
Chu Amiens
Amiens, France, 80054
Actively Recruiting
2
CHU CAEN
Caen, France, 14033
Actively Recruiting
3
Chu Rouen
Rouen, France, 76031
Actively Recruiting
Research Team
C
Coquerel Dorothée
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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