Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis (FVS-RHIZA)

University Hospital, Rouen

Status and phase

Not yet enrolling

Phase 2

Conditions

Rhizarthrosis

Treatments

Drug: SVF injection into wrist

Study type

Interventional

Funder types

Other

Identifiers

NCT05708430

2018/0419/HP

Details and patient eligibility

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

History of intra-articular injection of the trapezio-metacarpal (corticoid or hyaluronic acid) in the last 6 months
Body Mass Index < 18 kg/m2
Contraindication to general or local anesthetics including XYLOCAINE 10 mg/mL ADRENALINE 0.005 mg/mL, solution for injection
Contraindication to sedation or general anesthesia (left to the discretion of the anesthesiologist)
Contraindication to liposuction (eg bleeding disorder)
Documented severe allergy to conventional antibiotics such as β-lactams, cyclins, macrolides, quinolones, aminoglycosides, etc...
Known hypersensitivity to human albumin or to any of the excipients (VIALEBEX 200 g/L, solution for infusion)
A general or local infection near the sampling or injection sites
Any surgery scheduled over the duration of the study of the hand (carpal tunnel type operation) or upper limb that may have an impact on the assessment of pain and/or functional indices
Persons on immunosuppressants: corticosteroid therapy > 10 mg/d, methotrexate > 25 mg/week, mycofenolate mofetil > 3 grams/d, azathioprine > 200 mg/d and intravenous cyclophosphamide and any biotherapy in the 90 days preceding the medical visit. inclusion
Congenital or acquired immune deficiency
Prescription of a new systemic treatment that may influence the condition of the hand (vasodilator or immunosuppressant) in the 90 days preceding inclusion
Persons infected with HIV, HCV, HBV, HTLV and syphilis
Contraindication to MRI, (eg, due to presence of pacemakers or other incompatible foreign material or claustrophobia)
Contraindication to the injection of gadolinated contrast product (gadolinium) for performing MRI (history of hypersensitivity to gadolinated contrast products)
Active COVID-19 infection (PCR positive)
Any cardiovascular, metabolic, endocrine, psychiatric or cancerous pathology in uncontrolled evolution