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    Summary
    EudraCT Number:2017-005165-49
    Sponsor's Protocol Code Number:PLX-HF-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-11
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2017-005165-49
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, Designed to Determine the Efficacy, Safety, and Tolerability of Intramuscular Administration of Allogeneic PLX-PAD Cells for the Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Placebo-Controlled, Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Patients who have Muscle Injury Following hip replacement or reconstruction due to Hip Fracture (HF)
    A.4.1Sponsor's protocol code numberPLX-HF-01
    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 SponsorPluristem Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPluristem Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPluristem Ltd
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressMatam Advanced Technology Park, Building #5
    B.5.3.2Town/ cityHaifa
    B.5.3.3Post code3508409
    B.5.3.4CountryIsrael
    B.5.4Telephone number+972747108600
    B.5.5Fax number+972747108765
    B.5.6E-mailnitsan.halevy@pluristem.com
    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.2.5The 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 namePLX-PAD
    D.3.4Pharmaceutical form Dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllogenic ex-vivo expanded placental adherent stromal cells (emiplacel)
    D.3.9.2Current sponsor codePLX-PAD
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 million to cells/mL
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue-engineered product (Ref: EMA/556256/2015)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboDispersion for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Muscle Injury Following Arthroplasty for Hip Fracture
    E.1.1.1Medical condition in easily understood language
    Muscle Injury after hip replacement or reconstruction following Hip Fracture
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028315
    E.1.2Term Muscle injuries
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to assess the efficacy, safety and tolerability of PLX-PAD IM administration for the treatment of muscle injury following arthroplasty for hip fracture.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the inclusion criteria listed below to be eligible for the study:
    1. Male or female subjects.
    2. Subjects 60 to 90 years of age, inclusive, at the time of Screening.
    3. Subjects suffering low energy trauma with intracapsular neck of femur fracture.
    4. Planned to be treated with THA or HA, via direct lateral approach, within 48 hours of hospital admission and 72 hours post-fracture.
    5. Subject able to walk 10 feet/3 meters before the fracture (with or without walking aids and without help of a person most of the time), based on self-report.
    E.4Principal exclusion criteria
    Subjects with any 1 of the exclusion criteria listed below will not be eligible for the study:
    1. Any significant musculoskeletal (including ectopic bone formation), neurologic or neuromuscular disease causing muscle weakness and/or affecting mobility at the time of Screening, based on the Investigator’s judgment.
    2. Current fracture is due to bone pathology other than osteoporosis (as diagnosed on the pre-operative X-ray) or due to high-energy trauma (e.g., car accident).
    3. Planned orthopedic surgery on lower limbs (excluding hip arthroplasty) within the next 12 months.
    4. Diabetes mellitus with glycosylated hemoglobin (HbA1c) >10% at Screening.
    5. Known current or history of proliferative retinopathy or diabetic retinopathy.
    6. Known active Hepatitis B virus or Hepatitis C virus infection at Screening.
    7. Known human immunodeficiency virus (HIV) infection, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn’s disease, etc).
    8. Immunosuppression due to illness or medication (e.g., high dose corticosteroids, calcineurin inhibitors, anti-tumor necrosis factor (TNF), anti-IL-6, anti-p40, etc; prednisone equivalent lower than 10 mg/day is accepted) at the time of Screening.
    9. AST or ALT >3× upper limit of normal (ULN).
    10. Subjects on renal replacement therapy or with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 (based on Modification of Diet in Renal Disease [MDRD] equation).
    11. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV) at Screening.
    12. Known uncontrolled severe hypertension.
    13. Treatment with anabolic steroids within 6 months prior to Screening.
    14. Albumin <2.5 g/dL.
    15. Active malignancy or history of malignancy within 3 years prior to Screening with the exception of successfully resected basal cell carcinoma or skin squamous cell carcinoma not located on the injured leg.
    16. Known diagnosis of moderate to severe dementia based on subject’s medical history, past Mini-Mental State Examination test score of ≤18 or equivalent, or severe psychiatric disorder.
    17. Known allergies to any of the following: DMSO, HSA, bovine serum albumin, PlasmaLyte and gentamicin (and other aminoglycoside antibiotics).
    18. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine, history of acute transfusion reaction, known allergy to more than 3 allergens, or in the opinion of the Investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions.
    19. Known history of severe atopic disease (including but not limited to chronic urticaria, respiratory allergy requiring oral steroids), known history of uncontrolled asthma (Global Initiative for Asthma [GINA] III-IV)
    20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
    21. Known history of drug or alcohol abuse in the past 12 months, based on self-report or medical record.
    22. History of autologous/allogeneic BM or solid organ transplantation.
    23. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before Screening.
    24. Current evidence/sign supporting an assessment of life expectancy of less than 6 months, for reasons other than HF complications, based on the Investigator’s judgment.
    25. Subject is currently enrolled in an investigational device or drug trial, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).
    26. Subject is detained or institutionalized under a court order or administrative order.
    27. In the opinion of the Investigator, the subject is unsuitable for participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Short Physical Performance Battery (SPPB) score at Week 26.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 6, 12, 26 and 52.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Hip abduction strength of the injured leg at Week 26.
    • Change from baseline to Week 26 in lower extremity measure (LEM).
    • All-cause mortality rate.

    Safety Endpoints:
    • Adverse events (AEs) and SAEs.
    • Safety laboratory data (hematology, biochemistry).
    • Vital signs.
    • Physical examination findings.

    Tolerability Endpoints:
    • Proportion of subjects (%) who prematurely discontinued from the study.
    • Proportion of subjects (%) who prematurely discontinued from the study due to AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Endpoints:
    • Hip abduction strength of the injured leg: Weeks 6, 12, 26, 52
    • Lower extremity measure (LEM): Day 5, Weeks 6, 12, 26, 52
    • All-cause mortality rate: throughout the study

    Safety Endpoints:
    • AEs and SAEs: throughout the study
    • Safety laboratory data (hematology, biochemistry): Screening, Days 1, 5; Weeks 6, 12, 26, 52
    • Vital signs: Screening, Days 0, 1, 5; Weeks 6, 12, 26, 52
    • Physical examination Screening, Day 5; Weeks 6, 12, 26, 52.

    Tolerability Endpoints: throughout the study
    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 Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    Germany
    Israel
    United Kingdom
    United States
    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 end of the clinical study is defined as having occurred when the last subject has completed their final follow-up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days7
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 204
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 131
    F.4.2.2In the whole clinical trial 240
    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 Decision2018-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-02
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