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    Summary
    EudraCT Number:2022-001784-27
    Sponsor's Protocol Code Number:2018/0419/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-05-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2022-001784-27
    A.3Full title of the trial
    Tolerance of intra-articular injection of autologous stromal vascular fraction for the treatment of rhizarthrosis


    Tolérance de l'injection intra-articulaire de fraction vasculaire stromale autologue pour le traitement de la rhizarthrose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tolerance of intra-articular injection of autologous stromal vascular fraction for the treatment of rhizarthrosis
    Tolérance de l'injection intra-articulaire de fraction vasculaire stromale autologue pour le traitement de la rhizarthrose
    A.3.2Name or abbreviated title of the trial where available
    FVS-RHIZA
    A.4.1Sponsor's protocol code number2018/0419/HP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDirection de la Recherche Clinique et de l'Innovation - CHU de Rouen
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDirection de la Recherche Clinique et de l'Innovation - CHU de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirection de la Recherche Clinique et de l'Innovation - CHU de Rouen
    B.5.2Functional name of contact pointDavid MALLEt
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen cedex
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number330232888265
    B.5.5Fax number330232888287
    B.5.6E-mailsecretariat.drc@chu-rouen.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Advanced Therapy Medicinal Products (ATMPs) punctually prepared (PP) : Autologous Stromal Vascular Fraction
    D.2.1.1.2Name of the Marketing Authorisation holderAutologous Stromal Vascular Fraction
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAutologous Stromal Vascular Fraction
    D.3.2Product code Autologous Stromal Vascular Fraction
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    Intraarticular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults with a rhizarthrosis stage DELL 1 to 3
    E.1.1.1Medical condition in easily understood language
    Adults with a rhizarthrosis stage DELL 1 to 3
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the research is to assess the tolerance at 6 months of intra-articular injection of FVS for the treatment of rhizarthosis.

    E.2.2Secondary objectives of the trial
    The secondary objectives of the research are to assess at 1, 3 and 6 months:
    - the efficacy of intra-articular injection of FVS on (1) functional level and on (2) pain,
    - (3) cartilage regeneration after intra-articular injection of FVS.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To evaluate the ability of injected FVS cells to form chondroblasts in vitro
    E.3Principal inclusion criteria
    • Adult (≥ 18 years old)
    • Rhizarthrosis DELL stage 1 to 3
    • 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
    • Affiliation to a social security scheme
    • Person who has read and understood the information letter and signed the consent form
    • For women :
    o Woman of childbearing age with effective contraception (Cf. CTFG) (oestrogen-progestins or intrauterine device or tubal ligation) for 3 months and a negative urine pregnancy test on inclusion (V1)
    o Postmenopausal woman: non-medically induced amenorrhea for at least 12 months before the inclusion visit

    E.4Principal 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/day, methotrexate > 25 mg/week, mycofenolate mofetil > 3 grams/day, azathioprine > 200 mg/day and intravenous cyclophosphamide and any biotherapy within 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
    • Pregnant woman or woman likely to be in the absence of effective contraception (Women of childbearing age must have a negative urine pregnancy test on inclusion)
    • Breastfeeding woman or absence of proven contraception
    • Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
    • Person taking part in the research participating in another trial / having participated in another trial within 6 months
    • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for his participation in the protocol or preventing him from giving his informed consent.
    E.5 End points
    E.5.1Primary end point(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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 6 month period post-surgery
    E.5.2Secondary end point(s)
    The secondary endpoints are to assess at 1, 3 and 6 months:
    • (1) Functional assessment of the hand:
    o Kapandji score
    o JAMAR and Key pinch
    o Active mobility of the trapezio-metacarpal in antepulsion and abduction
    o Grinding test
    o DASH and PWRHE quick score
    • (2) Evaluation of pain by the EVA scale and by monitoring the progress of long-term analgesic treatment
    • (3) Assessment of cartilage regeneration
    o Evaluation by MRI of the cartilage:
    - Evaluation of intra-articular inflammation of the trapezio-metacarpal
    - Control of peri-articular inflammatory areas (in particular the flexor carpi radialis or the scapho-trapezio-trapezoid)
    - Assessment of cartilage thickness
    - Significance of TM subluxation
    o X-ray of the trapezio-metacarpal (Kapandji views):
    - Evaluation of the thickness of the articular line of the trapezio-metacarpal
    - Appearance or regression of signs of osteoarthritis (geode, condensation, osteophyte)
    - Trapezio-metacarpal deformity (DELL classification, Appendix 1)
    - Significance of TM subluxation
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1, 3 and 6 months post-surgery
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The visit at 6 month post-surgery is the last visit and the end of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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