Rhizarthrosis Clinical Trials

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

Status: Unknown
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Rhizarthrosis DELL stage 1 to 3 (see appendix 1)

• 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 (see Appendices 2 and 3)

• Affiliation to a social security scheme

• Person who has read and understood the information letter and signed the consent form

Contact Information
Primary
Coquerel Dorothée
Dorothee.Coquerel@chu-rouen.fr
0232885365
Time Frame
Start Date: 2023-04-01
Completion Date: 2025-08-01
Participants
Target number of participants: 12
Treatments
Experimental: SVF injection
Intra-articular injection of autologous cells from the stromal vascular fraction derived from adipose tissue
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov