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

Primary Purpose

Rhizarthrosis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SVF injection into wrist
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhizarthrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SVF injection

    Arm Description

    Intra-articular injection of autologous cells from the stromal vascular fraction derived from adipose tissue

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2023
    Last Updated
    January 23, 2023
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05708430
    Brief Title
    Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
    Acronym
    FVS-RHIZA
    Official Title
    Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhizarthrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SVF injection
    Arm Type
    Experimental
    Arm Description
    Intra-articular injection of autologous cells from the stromal vascular fraction derived from adipose tissue
    Intervention Type
    Drug
    Intervention Name(s)
    SVF injection into wrist
    Intervention Description
    Intra-articular injection of autologous cells from the stromal vascular fraction derived from adipose tissue
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Coquerel Dorothée
    Phone
    0232885365
    Email
    Dorothee.Coquerel@chu-rouen.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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