Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05708430

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

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Rhizarthrosis Dell stage 1 to 3
  • At least 6 months of symptomatic medical treatment including analgesics, orthosis, anti-inflammatory drugs, or intra-articular injections that have become ineffective
  • Pain score of 4 or higher on the Visual Analog Scale
  • QuickDASH or PRWHE score of 20/100 or higher
  • Affiliated with a social security scheme
  • Able to read, understand the information letter, and provide signed consent
Not Eligible

You will not qualify if you...

  • Intra-articular injection in the trapezio-metacarpal joint within the last 6 months
  • Body Mass Index below 18 kg/m2
  • Contraindications to general or local anesthetics including specific solutions
  • Contraindications to sedation or general anesthesia
  • Contraindications to liposuction such as bleeding disorders
  • Severe allergy to conventional antibiotics
  • Known hypersensitivity to human albumin or any excipients in the infusion solution
  • Active local or general infection near sampling or injection sites
  • Scheduled hand or upper limb surgery during study
  • Use of immunosuppressants above specified doses within 90 days before inclusion
  • Congenital or acquired immune deficiency
  • New systemic treatments affecting hand condition within 90 days prior
  • Infection with HIV, HCV, HBV, HTLV, or syphilis
  • Contraindications to MRI or gadolinium contrast
  • Active COVID-19 infection
  • Uncontrolled cardiovascular, metabolic, endocrine, psychiatric, or cancer conditions

AI-Screening

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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

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Research Team

C

Coquerel Dorothée

CONTACT

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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