Study of Safety for Injection of Patients Own Fat-Derived Cells into the Thumb Joint to Treat Rhizarthrosis

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 persons 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.

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