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

Condition(s) studied

Investigational drug(s) / intervention(s)

SVF injection into wrist: Intra-articular injection of autologous cells from the stromal vascular fraction derived from adipose tissue

Study summary

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. However, no curative medical treatment exists to date. The treatment is initially based on a symptomatic approach: analgesics, non-steroidal anti-inflammatories, immobilization orthoses or even intra-articular injections of corticosteroids or hyaluronic acid. When it is exceeded, surgical treatment is considered. This is also not a curative treatment. Indeed, the 3 types of main interventions proposed (arthrodesis, arthroplasty or trapezectomy) each have significant consequences for the patient: stiffness for the arthrodesis, risk of dislocation or failure of the material for the prosthesis, long consequences for the trapezectomy. , or potential complications of surgery.

Stem cell-based therapies, in particular cells of the stromal vascular fraction derived from adipose tissue (FVS), are promising in various indications, including osteoarthritis of the knee. Autologous FVS is readily accessible by standard liposuction, with FVS isolated from adipose tissue by centrifugation. A safe and well-tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties, its safety has been demonstrated in particular during phase 1 trials. Our objective is to assess the tolerance of an injection of FVS into the trapezio-metacarpal joint, when standard medical treatment has failed, and the rhizarthrosis has become painful enough to be eligible for surgery. Due to its immunomodulatory and cartilage regeneration properties, this injection would be performed to offer a less invasive and possibly curative treatment instead of surgery.

Eligibility

Primary outcome measure(s)

• The primary endpoint is the number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS. — 6 months
  The primary endpoint is the number of treatment-attributable Grade ≥ 3 adverse reactions occurring over a 6-month period after intra-articular injection of FVS.

Trial sites (3)

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