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    Summary
    EudraCT Number:2015-005580-16
    Sponsor's Protocol Code Number:REDDSTAR-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-005580-16
    A.3Full title of the trial
    A Phase 1b, open label, uncontrolled non-randomised single dose study to examine the safety of topically applied bone marrow derived allogeneic mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b, open label, uncontrolled non-randomised single dose study to examine the safety of topically applied stem cells (REDDSTAR ORBCEL-M) to patients with non-healing diabetic foot wounds
    A.4.1Sponsor's protocol code numberREDDSTAR-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 SponsorSteno Diabetes Center A/S
    B.1.3.4CountryDenmark
    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 supportSteno Diabetes Center A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportEU FP7 REDDSTAR (Repair of Diabetic Damage by Stromal Cell Administration), grant No. 305736
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDanTrials ApS
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street Addressc/o Bispebjerg Hospital, Zelo Phase I Unit, Bldg. 11B, 1st Floor, 23 Bispebjerg Bakke
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post codeDK-2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number453135 2683
    B.5.5Fax number453531 5248
    B.5.6E-mailtb@dantrials.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 nameREDDSTAR ORBCEL-M
    D.3.4Pharmaceutical form Cutaneous suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREDDSTAR ORBCEL-M
    D.3.9.3Other descriptive nameEX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB27304
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35294 cells/μl
    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
    Patients with non-healing neuroischaemic diabetic foot wounds
    E.1.1.1Medical condition in easily understood language
    Patients with non-healing diabetic foot wounds
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the feasibility and safety of topically administered allogeneic bone marrow-derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-80 years.
    2. Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease).
    3. HbA1c ≤ 97 mmol/mol (≤ 11%).
    4. Males or non-pregnant females.
    5. Understand trial information document.
    6. Provide written informed consent.
    7. Duration of (diabetic foot) wound > 4 but < 52 weeks.
    8. Reduction of < 50% area over 4 weeks despite standard care (standard care; off-loading, weekly debridement, dressings, orthotic).
    9. Wound area with sharp debridement of ≥ 0.5 but ≤ 4.0 cm2.
    10. Clinically non-infected wound.
    11. Texas wound stage 1a, 1c or 2a.
    12. Location of wound below malleolus.
    13. Affected limb toe pressure ≥ 40mmHg; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms).
    14. An ankle-brachial systolic pressure index between 0.7 and 1.3.
    15. Diagnosis of peripheral neuropathy using ADA guidelines (monofilament/vibration sensation/biothesiometer).
    16. Adhere to study visit protocol.
    17. Adhere to offloading devices/orthotic.
    E.4Principal exclusion criteria
    1. Life expectancy of less than 12 months.
    2. Patients with a definite diagnosis of any immunodeficiency disorder.
    3. Viral hepatitis [patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)].
    4. Active, uncontrolled connective tissue disease.
    5. Renal failure as defined by serum creatinine > 220 µmol/L.
    6. Liver function tests (e.g. AST, ALT) that are > 2.0 times ULN.
    7. Poor nutritional status as measured by serum albumin < 30 mg/dL.
    8. Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).
    9. Active wound infection (i.e. recent onset of erythema, oedema, and increased temperature of the foot with normal radiographs).
    10. Diabetic Charcot neuroarthropathy or other structural deformity that would prevent adequate off-loading of the study foot.
    11. Treatment with any systemic corticosteroid immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity to be treated within 30 days prior to signing the informed consent form.
    12. Having received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study.
    13. A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient’s medical history, which in the Investigator’s opinion may pose a threat to patient compliance.
    14. History of non-compliance with treatment or clinical visit attendance (i.e. this study requires that patients will comply with the protocol and ulcer care regimen).
    15. Any unstable medical condition judged by the Investigator or Medical Monitor that would cause the study to be detrimental to the patient.
    16. A Haemoglobin A1c (HbA1c) test result of > 11% (>97 mmol/mol) documented at the screening visit.
    17. Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.
    18. Wounds with an aetiology not related to diabetes.
    19. More than three wounds on the target lower extremity.
    20. The wound to be studied not anatomically distinct from another wound(s) (separated by < 1 cm from another wound or would interfere with standard of care treatment of another wound. Only one single wound per one study subject can be treated in this study.
    21. Wounds which decrease in area by >50% during the screening 4-week run-in period.
    22. Ulcers with underlying osteomyelitis on the leg with the wound to be treated.
    23. Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).
    24. Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
    25. Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
    26. Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.
    27. Received dermal substitute or living skin equivalent (Leukopatch within 30 days prior to signing the informed consent form.
    28. Received prior PDGF-BB (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form.
    29. Has known history of clinical sensitivity reactions to products of bovine origin or to the primary or secondary dressings used in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Number and severity of serious adverse events considered related to treatment with study drug (mesenchymal stromal cells; REDDSTAR ORBCEL-M)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From time of application of mesenchymal stromal cells until end of study visit.
    E.5.2Secondary end point(s)
    Safety:
    Adverse events (serious or non-serious).

    Efficacy:
    a) Ulcer healing trajectories over time as assessed by plots of percentages of ulcer closure versus assessment of time.
    b) Time to complete ulcer closure (as defined as Treatment Day 1 to the first visit when closure is documented).
    c) Absolute and percent changes in ulcer area from baseline at weekly intervals through Week 12.
    d) Durability of ulcer closure as measured at 4 week intervals for 12 weeks from date of ulcer closure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:
    From time of application of mesenchymal stromal cells until end of study visit.

    Efficacy:
    a) From time of application of mesenchymal stromal cells until 12 weeks after (or until ulcer closure), measured at weekly intervals.
    b) From time of application of mesenchymal stromal cells until ulcer closure, measured at weekly intervals.
    c) From time of application of mesenchymal stromal cells until 12 weeks after (or until ulcer closure), measured at weekly intervals.
    d) From time of ulcer closure until 12 weeks after (or until re-opening of ulcer), measured at 4 week intervals.
    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 No
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LSLV
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 3
    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 state9
    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 Decision2016-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-01
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