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    Summary
    EudraCT Number:2018-000967-10
    Sponsor's Protocol Code Number:RC31/14/7441
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-23
    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 number2018-000967-10
    A.3Full title of the trial
    Autologous transplantation of Adipose tissue derived mesenchymal Stroma/stem Cells (ASC) in patients with critical limb ischemia: a phase II study (ACellDream 2).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adipose Cell Derived Regenerative Endothelial and Angiogenic Medicine
    A.3.2Name or abbreviated title of the trial where available
    ACellDREAM 2
    A.4.1Sponsor's protocol code numberRC31/14/7441
    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 SponsorUniversity Hospital Toulouse
    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 supportUniversity Hospital Toulouse
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Toulouse
    B.5.2Functional name of contact pointPauze Amandine
    B.5.3 Address:
    B.5.3.1Street AddressHôtel-Dieu, 2 rue Viguerie, TSA 80039
    B.5.3.2Town/ cityToulouse cedex 9
    B.5.3.4CountryFrance
    B.5.4Telephone number+33561778434
    B.5.5Fax number+33561778411
    B.5.6E-mailpauze.a@chu-toulouse.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 No
    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 nameadipose derived stromal cells (ASC)
    D.3.4Pharmaceutical form Solution for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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
    Patients with rest pain or ischemic ulcers/gangrene of the lower limb and without option for revascularization or poor option.

    Or patients with with rest pain or ischemic ulcers and persistent CLI after revascularization, or with severe cardiac, respiratory or renal disease who are at increased risk of complication from surgery or anesthesia, or with moderately severe or severe heart failure, severe or very severe Chronic Obstructive Pulmonary disease or severe renal disease.
    E.1.1.1Medical condition in easily understood language
    Patients with Peripheral Artery Disease (PAD) in inferiors limbs with no option of revascularization with usual methods or with high risk of failure of revascularization or contraindication.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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 study is to evaluate the efficacy of the injection of autologous ASC, in term of recovering of critical limb ischemia, in patients with critical limb ischemia of inferior limbs
    E.2.2Secondary objectives of the trial
    1. Evaluation of the neo-angiogenesis of the treated limb (Angio IRM),
    2. Evaluation of the blood flow and hemodynamic parameters of the limb (Doppler, TCPO2 and pressure),
    3. Percentage reduction of wound area (if present),
    4. Evaluation of time to complete healing,
    5. Evaluation of pain reduction,
    6. Evaluation of the product safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients over 18 years old,
    • Rest pain or ischemic ulcers /gangrene of the lower limb, present for at least 15 days, with ankle pressures less or equal than 50 mmHg or toe systolic pressure less than 30 mmHg or TcPO2 less or equal than 35 mmHg,
    • Patients who signed the informed consent,
    • Patient affiliated to a social security system,
    Patient with persistent CLI after revascularization will be included if :
    1/ they have severe cardiac, respiratory or renal disease who are at increased risk of complication from surgery or anesthesia, e.g. moderately severe or severe heart failure (NYHA class III or IV), severe or very severe Chronic Obstructive Pulmonary disease or severe renal disease (creatinine clearance <30mL/minute).
    OR
    2/ there is no option for endovascular or open surgery revascularization ; or poor option (defined by: need for an infra-popliteal by-pass without the availability of autologous great saphenous vein, need for use of great saphenous vein <3mm in diameter for tibial level bypass based on venous duplex ultrasound, or calcified or small (<2 mm) distal target vessel, or open wound on the receiving site or infrapopliteal PAD)
    E.4Principal exclusion criteria
    • History of cancer
    • Need of a major amputation (amputation at or above the ankle) within 4 weeks,
    • Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
    • TcPO2 <10mmHg at rest and < 30mmHg sitting with legs dependent (very poor vascular reserve),
    • Positive HIV-1 or 2, HTLV-1 or 2, HBV (except vaccine profile), Syphilis (except inactive disease), or HCV,
    • Patients necessitating drugs with inhibitory or stimulatory effect on the growth and multiplication of cells or drugs with immunosuppressive effect: Cyclosporine, Mycophenolate mofetil, Azathioprine, Tacrolimus (systemic), Anthracyclines, Neupogene or equivalent, Etanercept, Interferons, Corticoids at anti-inflammatory doses,
    • No possibility of adipose tissue harvest and cell injection in the leg,
    • Another clinical trial participation (except non interventional studies),
    • Patient under judicial protection,
    • Pregnant and breastfeeding women,
    • Women of childbearing age without effective contraception,
    • Refusal of the patient to participate in the study,
    • Lack in understanding the nature and aims of the study and/or difficulties in communication with the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients alive without amputation and without critical limb ischemia (defined as the presence of rest pain or ischemic ulcer and ankle pressures less or equal than 50 mmHg or toe systolic pressure less than 30 mmHg or TcPO2 less or equal than 35 mmHg), at 6 month.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 month
    E.5.2Secondary end point(s)
    1. Blind evaluation (to patient and sequence) of the number of new vessels in the treated limb by standardized angiographic magnetic resonance.
    2. Blood flow velocity evaluated by laser Doppler, transcutaneous pressure of oxygen (TcPO2 (mmHg)), ankle pressure (mmHg).
    3. Percentage reduction of wound surface (standardized layer measurement) from baseline.
    4. Percentage of patients with complete ulcer healing.
    5. Pain reduction from baseline evaluated by standardized evaluation (visual scale and drug consumption).
    6. Percentage of patients with wound infection (expected adverse events).
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary events will be evaluated at D7, D30, D90, and D180.
    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 Yes
    E.8.1.7.1Other trial design description
    SINGLE ARM
    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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state43
    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 Decision2019-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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