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    Summary
    EudraCT Number:2016-004684-40
    Sponsor's Protocol Code Number:N-O_CLI_Study
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004684-40
    A.3Full title of the trial
    Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine.
    Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’.
    Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with no-option critical limb ischemia (N-O CLI).
    Regeneracja uszkodzeń niedokrwiennych układu sercowo-naczyniowego z wykorzystaniem Galarety Whartona jako nieograniczonego źródła terapeutycznego komórek macierzystych (CIRCULATE - Projekt Strategiczny Narodowego Centrum Badań i Rozwoju "STRATEGMED II") Zastosowanie innowacyjnego leku CardioCell w leczeniu pacjentów z krytycznym niedokrwieniem kończyn dolnych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regeneration of ischemic damages in cardiovascular system using Wharton’s jelly as an unlimited source of mesenchymal stem cells for regenerative medicine.
    Project of the National Centre for Research and Development (Poland) ‘STRATEGMED II’.
    Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in patients with no-option critical limb ischemia (N-O CLI).
    Regeneracja uszkodzeń niedokrwiennych układu sercowo-naczyniowego z wykorzystaniem Galarety Whartona jako nieograniczonego źródła terapeutycznego komórek macierzystych (CIRCULATE - Projekt Strategiczny Narodowego Centrum Badań i Rozwoju "STRATEGMED II") Zastosowanie innowacyjnego leku CardioCell w leczeniu pacjentów z krytycznym niedokrwieniem kończyn dolnych.
    A.3.2Name or abbreviated title of the trial where available
    CardioCell evaluation in N-O CLI
    Ocena CardioCell w N-O CLI
    A.4.1Sponsor's protocol code numberN-O_CLI_Study
    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 SponsorKrakowski Szpital Specjalistyczny im. Jana Pawła II
    B.1.3.4CountryPoland
    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 supportKrakowski Szpital Specjalistyczny im. Jana Pawła II
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportNarodowe Centrum Badań i Rozwoju (NCBiR)
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEwa Gąsior
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressPrądnicka 80
    B.5.3.2Town/ cityCracow
    B.5.3.3Post code31-202
    B.5.3.4CountryPoland
    B.5.4Telephone number48126142000
    B.5.5Fax number48126142266
    B.5.6E-maile.gasior@szpitaljp2.krakow.pl
    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 nameCardioCell
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWharton's jelly mesenchymal stem cells
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameWJ MSC (Wharton's jelly mesenchymal stem cells)
    D.3.9.4EV Substance CodeSUB191586
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30mln WJ MSC/20ml
    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 No
    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 numberEMA/CAT/625295/2016
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntraarterial use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical limb ischemia
    Krytyczne niedokrwienie kończyn
    E.1.1.1Medical condition in easily understood language
    Critical limb ischemia
    Krytyczne niedokrwienie kończyn
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10058069
    E.1.2Term Critical limb ischemia
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the regeneration ischemia cardiovascular system in critical limb ischemia without the possibility of revascularization (N-O CLI) by treatment with CardioCell.
    Ocena zdolności regeneracji uszkodzeń niedokrwiennych układu sercowo-naczyniowego w krytycznym niedokrwieniu kończyn dolnych bez możliwości leczenia rewaskularyzacyjnego (N-O CLI), za pomocą leczenia preparatem CardioCell.
    E.2.2Secondary objectives of the trial
    Assess the efectiveness of the use of the product on the basis of the increase walking distance without pain, assessed at thye main hospitalization and at 6 month follow-up beetween two groups (active vs sham).
    Ocena skuteczności zastosowania preparatu na podstawie oceny wzrostu dystansu marszu bez bólu, ocenianego podczas głównej hospitalizacji i w obserwacji 6 miesięcznej pomiędzy dwoma grupami (aktywna vs sham).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients able to walk
    - Male and female patients, aged 18-80 years
    - No-option CLI (definition: exhausted revascularization options including surgery or endovascular treatment) in Rutherford stage 4-5
    - In case of bilateral N-O CLI, the limb with shorter claudication distance will be treated
    - Presence of adequate inflow (patent iliac and common femoral arteries)
    - Run-off through at least one (even partially seen) below-the-knee (BTK) artery
    - Signed informed consent
    - Pacjenci mogący chodzić,
    - Pacjenci płci męskiej i żeńskiej w wieku 18-80 lat
    - Pacjenci z krytycznym niedokrwieniem kończyny bez możliwości leczenia rewaskularyzacyjnego, w klasie Rutherford 4-5
    - W przypadku obustronnego niedokrwienia kończyn dolnych, w ramach badania klinicznego będzie leczona kończyna o krótszym dystansie chromania
    - Zachowany napływ krwi do leczonej kończyny (drożne tętnice biodrowe oraz udowa wspólna)
    - Zachowany przepływ krwi przez co najmniej jedną (chociaż częściowo widoczną) tętnicę poniżej kolana (ang. BTK)
    - Podpisanie świadomej zgody
    E.4Principal exclusion criteria
    - Malignancy
    - Moderate or severe immunodeficiency
    - Acute or chronic bacterial or viral infectious disease
    - Soft tissue disease or local infection in a place of required artery puncture
    - Pregnancy or breastfeeding
    - Any objective or subjective reason for inability to attend follow-up visits
    - Females of childbearing potential, who does not want to use a highly effective method of contraception
    - Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
    - Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project
    - Life expectancy < 1 year
    - Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
    - Nowotwór złośliwy
    - Umiarkowane lub ciężkie upośledzenie odporności
    - Ostre lub przewlekłe, bakteryjne lub wirusowe choroby zakaźne
    - Choroby tkanek miękkich lub lokalne zakażenia w miejscu wymaganych nakłuć tętnicy
    - Ciąża lub karmienie piersią
    - Wszelkie obiektywne lub subiektywne przyczyny braku możliwości udziału w wizytach kontrolnych
    - Kobiety w wieku rozrodczym, które nie wyrażają zgody na korzystanie z bardzo skutecznych metod antykoncepcji
    - Kobiety w wieku rozrodczym bez potwierdzenia negatywnego wyniku testu ciążowego z moczu lub z krwi
    - Udział w innych badaniach klinicznych, które nie osiągnęły punktu końcowego lub mogą kolidować z udziałem pacjenta w badaniu
    - Przewidywana długość życia < 1 rok
    - Współistniejąca choroba lub dolegliwość, która zdaniem badacza, wyklucza pacjenta z udziału w badaniu
    E.5 End points
    E.5.1Primary end point(s)
    Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy).
    Wzrost dystansu marszu bez bólu, oceniany podczas głównej hospitalizacji i w obserwacji 6 miesięcznej pomiędzy dwoma grupami (aktywna vs sham).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 12 months Follow-up
    6 i 12 miesięczna wizyta kontrolna
    E.5.2Secondary end point(s)
    1. Amputation-free survival period evaluation of treated leg at 6 month and 1 year FU.
    2. Ulcer-free survival (in patients without ulceration at baseline evaluation) and ulcer-extension free survival (in patients with ulceration in the beginning of the trial) of treated leg in period evaluation at 6 month and 1 year FU.
    3. Change in tissue oxygen/CO2 tension, assessed by NIRS method at each trial evaluation point.
    4. An improvement of tissue perfusion assessed in MRI at each trial evaluation point.
    5. Change in transcutaneous pressure of O2 (tcpO2) between two groups (active vs placebo therapy) at each trial evaluation point.
    6. Change in ABI score at each trial evaluation point.
    7. Quality of life improvement, assessed by SF-36 v2 questionnaire or other dedicated for investigated population at each trial evaluation point.
    1. Czas przeżycia bez amputacji, oceniany w 6 i 12 miesiącu FU.
    2. Czas przeżycia bez owrzodzenia, (u pacjentów u których wyjściowo nie obserwowano owrzodzeń), oraz czas przeżycia bez progresji owrzodzeń (u pacjentów u których wyjściowo były obserwowane owrzodzenia) oceniany w 6 i 12 miesiącu FU.
    3. Zmiana stężenia tkankowego tlenu, oceniana metodą NIRS wyjściowo oraz na wszystkich wizytach kontrolnych.
    4. Poprawa perfuzji tkanek oceniona w MRI wyjściowo i na wszystkich wizytach kontrolnych.
    5. Zwiększenie przezskórnego stężenia O2 (TO2) ocenianego wyjściowo i na każdej wizycie kontrolnej pomiędzy dwoma grupami (aktywna vs sham).
    6. Zmiana wartości wskaźnika kostkowo-ramiennego (ang. ABI) ocenianego wyjściowo i na każdej wizycie kontrolnej.
    7. Poprawa jakości życia, oceniona za pomocą kwestionariusza SF-36 lub innego dedykowanego dla badanej populacji wyjściowo i na każdej wizycie kontrolnej.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months follow-up
    3, 6 i 12 miesięczna wizyta kontrolna
    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) 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 Information not present in EudraCT
    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 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
    Ostatnia wizyta ostatniego pacjenta
    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 months8
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 Yes
    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 state115
    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)
    In the case of confirmation of the efficacy and safety of the investigational product, the sponsor of the study and the manufacturer of the product CardioCell will make every effort to be able to provide the preparation CardioCell to each patient who was randomized to the placebo group, and expresses the wish receiving such a treatment.
    W przypadku potwierdzenia skuteczności oraz bezpieczeństwa badanego produktu, sponsor badania oraz wytwórca produktu CardioCell dołożą wszelkich starań, żeby możliwe było podanie preparatu CardioCell każdemu pacjentowi, który został zrandomizowany do grupy placebo i wraża ochotę otrzymania takiego leczenia.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Krakowski Szpital Specjalistyczny im. Jana Pawła II, Zakład Medycyny Nuklearnej
    G.4.3.4Network Country Poland
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Krakowski Szpital Specjalistyczny im. Jana Pawła II, Zakład Radiologii i Diagnostyki Obrazowej
    G.4.3.4Network Country Poland
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Krakowski Szpital Specjalistyczny im. Jana Pawła II, Laboratorium Analityczne
    G.4.3.4Network Country Poland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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