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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-002732-75
    Sponsor's Protocol Code Number:MSC-ACLrep
    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:2020-07-10
    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 number2020-002732-75
    A.3Full title of the trial
    The use of mesenchymal stem cells from the bone marrow stroma for reconstruction of the anterior cruciate ligament
    Zastosowanie mezenchymalnych komórek macierzystych z podścieliska szpiku w celu rekonstrukcji więzadła krzyżowego przedniego kolana.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of mesenchymal stem cells from the bone marrow stroma for reconstruction of the anterior cruciate ligament
    Zastosowanie mezenchymalnych komórek macierzystych z podścieliska szpiku w celu rekonstrukcji więzadła krzyżowego przedniego kolana.
    A.3.2Name or abbreviated title of the trial where available
    MSC-ACLrep
    MSC-ACLrep
    A.4.1Sponsor's protocol code numberMSC-ACLrep
    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 SponsorAlexander IV sp. Partnership Ortopedika Surgery Specialistic Center
    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 supportAlexander IV sp. Partnership Ortopedika Surgery Specialistic Center STRATEGMED 1/235773/19/NCBR/2016
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexander IV sp. Partnership Ortopedika Surgery Specialistic Center
    B.5.2Functional name of contact pointMikołaj Wróbel
    B.5.3 Address:
    B.5.3.1Street AddressModlińska 310/312
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code03-152
    B.5.3.4CountryPoland
    B.5.4Telephone number4822510 26 60
    B.5.5Fax number4822510 26 61
    B.5.6E-mailmikolaj.wrobel@ortopedika.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.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameBone-marrow derived autologous stem cells
    D.3.2Product code MSC ATiMP
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular 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 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/814774/2018
    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
    Rupture of the anterior cruciate ligament in the knee
    Zerwanie więzadła krzyżowego przedniego w kolanie
    E.1.1.1Medical condition in easily understood language
    Rupture of the anterior cruciate ligament in the knee
    Zerwanie więzadła krzyżowego przedniego w kolanie
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049548
    E.1.2Term Knee operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to assess the intra-ligamental safety of administration of an advanced therapy medicinal product - autologous mesenchymal stem cells isolated from bone marrow (MSC ATiMP) in the treatment of anterior cruciate ligament in the knee.
    Celem badania jest ocena bezpieczeństwa dostawowego (śródwięzadłowego) podania produktu leczniczego terapii zaawansowanej – autologicznych mezenchymalnych komórek macierzystych wyizolowanych ze szpiku kostnego (MSC ATiMP) w leczeniu zerwanego więzadła krzyżowego przedniego w kolanie.
    E.2.2Secondary objectives of the trial
    A secondary goal is the preliminary assessment of the efficacy of intrathecal (intramiginal) administration of MSC ATiMP in the treatment of anterior cruciate ligament ruptures.
    Celem pobocznym jest wstępna ocena skuteczności dostawowego (śródwięzadłowego) podania MSC ATiMP w leczeniu zerwań więzadła krzyżowego przedniego.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Expressing informed consent to participate in the study along with participation in rehabilitation.
    2. No contraindications to bone marrow donation.
    3. Diagnosis of anterior knee cruciate ligament rupture not later than 6 months before qualification.
    4. Age: 18-45 years old.
    5. Patient's readiness to follow the procedures related to the trial (in the opinion of the principal investigator).
    6. For women of childbearing potential, the inclusion criterion is a negative laboratory pregnancy test and no pregnancy during study participation and subsequent imaging (e.g. use of effective contraception and a negative pregnancy test prior to imaging).
    1. Wyrażenie świadomej zgody na udział w badaniu wraz z udziałem w rehabilitacji.
    2. Brak przeciwwskazań do donacji szpiku kostnego.
    3. Rozpoznanie zerwania więzadła krzyżowego przedniego kolana nie później niż 6 miesięcy przed kwalifikacją
    4. Wiek: 18 - 45 lat.
    5. Gotowość pacjenta do przestrzegania procedur związanych z badaniem (w ocenie głównego badacza).
    6. W przypadku kobiet w wieku rozrodczym kryterium włączenia jest ujemny wynik laboratoryjnego testu ciążowego oraz brak ciąży w trakcie uczestnictwa w badaniu i podczas kolejnych badań obrazowych (np. stosowanie skutecznej metody antykoncepcji oraz negatywny wynik laboratoryjnego testu ciążowego przed badaniem obrazowym).
    E.4Principal exclusion criteria
    1. Lack of consent for bone marrow collection or failure to meet the criteria for tissue donation.
    2. Other ligament pathologies requiring surgery, confirmed by MRI and clinical examination.
    3. A neurological or psychiatric disorder which, in the investigator's opinion, will prevent sufficient cooperation.
    4. Failure of at least one organ (heart, liver, kidneys, lungs) with statistically predicted life expectancy <2 years.
    5. Condition after oncological treatment for malignant tumor (grace period of 5 years).
    6. Participation in any other clinical trial (grace period of at least six months).
    7. Participation in a therapeutic experiment (grace period of at least 2 years)
    8. Allergy to gentamycin or any of the following: penicillin or streptomycin.
    9. Systemic immunosuppressive treatment currently and / or during the last 3 years before the date of inclusion in the study (non-biological immunosuppressive drugs may be used in doses maintaining remission provided that the exacerbation of the underlying disease is excluded).
    10. Active infection: HIV, HBV, HCV, syphilis.
    11. Pregnancy.
    12. Co-occurrence of another disease at the same time, which in the investigator's opinion may affect the course of the procedures used or the assessment of the safety and effectiveness of the treatment used.
    13. Irregularities in biochemical tests
    - hemoglobin <8 g / dl,
    - Platelet count <80,000 or> 600,000 platelets.
    14. General diseases, including diabetes, gout, especially those requiring chronic intake of oral steroids, in intravenous or topical injections.
    15. Osteoarthritis.
    16. Past infections in the knee.
    17. Condition after lateral or medial meniscectomy
    18. Disorder of the mechanical axis of the lower limb> 3 degrees.
    19. Previous cartilage repair procedures or ligament reconstruction.
    20. Diseases or injuries of the musculoskeletal system impeding efficient mobility.
    21. Cardiovascular or neurological diseases affecting the condition of the lower extremities.
    22. BMI> 27
    23. Smoking cigarettes, pipes, cigars.
    24. Alcohol dependence syndrome.
    25. Use of drugs and / or other intoxicants.
    26. Contraindications to perform an MRI examination, including all implants for which the patient does not have documentation to determine compatibility with the MRI examination.
    1. Brak zgody na pobranie szpiku kostnego lub niespełnienie kryteriów kwalifikacji do donacji tkanki.
    2. Inne patologie więzadłowe wymagające zaopatrzenia operacyjnego, potwierdzone w badaniu MRI i badaniu klinicznym.
    3. Schorzenie neurologiczne lub psychiatryczne, które w opinii badacza będzie uniemożliwiało wystarczającą współpracę.
    4. Niewydolność co najmniej jednego narządu (serca, wątroby, nerek, płuc) o statystycznie przewidywanym czasie życia <2 lat.
    5. Stan po leczeniu onkologicznym z powodu nowotworu złośliwego (okres karencji 5 lat).
    6. Uczestnictwo w jakimkolwiek innym badaniu klinicznym (okres karencji co najmniej 6 miesięcy).
    7. Uczestnictwo w eksperymencie leczniczym (okres karencji co najmniej 2 lat)
    8. Uczulenie na gentamycynę lub którykolwiek z wymienionych: penicylina lub streptomycyna.
    9. Systemowe leczenie immunosupresyjne obecnie lub/i w czasie ostatnich 3 lat przed momentem włączenia do badania (dopuszczalne jest stosowanie niebiologicznych leków immunosuperesyjnych w dawkach podtrzymujących stan remisji pod warunkiem wykluczenia zaostrzenia choroby podstawowej) .
    10. Aktywne zakażenie: HIV, HBV, HCV, kiła.
    11. Ciąża.
    12. Współwystępowanie jednocześnie innej choroby, która w opinii badacza może wpływać na przebieg stosowanych procedur lub ocenę bezpieczeństwa i skuteczności zastosowanego leczenia.
    13. Nieprawidłowości w badaniach biochemicznych
    - hemoglobina < 8 g/dl,
    - Liczba płytek krwi <80 000 lub > 600 000 płytek krwi.
    14. Choroby ogólne, w tym cukrzyca, dna moczanowa, szczególnie wymagające przewlekłego przyjmowania leków sterydowych doustnych, w postaci dożylnej lub miejscowo w zastrzykach.
    15. Osteoartroza.
    16. Przebyte infekcje w obrębie kolana.
    17. Stan po meniscektomii bocznej lub przyśrodkowej
    18. Zaburzenie osi mechanicznej kończyny dolnej >3 stopni.
    19. Przebyte wcześniej zabiegi naprawcze chrząstki lub rekonstrukcja więzadeł.
    20. Schorzenia lub urazy narządu ruchu utrudniające sprawne poruszanie się.
    21. Schorzenia układu krążenia lub neurologiczne wpływające na stan kończyn dolnych.
    22. BMI > 27
    23. Palenie papierosów, fajki, cygar.
    24. Zespół zależności alkoholowej.
    25. Stosowanie narkotyków lub/i innych środków odurzających.
    26. Przeciwwskazania do wykonania badania MRI w tym wszystkie implanty, wobec których pacjent nie posiada dokumentacji pozwalającej stwierdzić kompatybilność z badaniem MRI.

    E.5 End points
    E.5.1Primary end point(s)
    Safety assessment: Type and frequency of adverse reactions and events
    Ocena bezpieczeństwa: Rodzaj i częstość występowania reakcji i zdarzeń niepożądanych
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits: 2, 3, 4, 5, 6,
    Wizyty: 2, 3, 4, 5, 6,
    E.5.2Secondary end point(s)
    Initial effectiveness assessment: Scoring in functional scales (KOOS, Lysholm) and in imaging tests (MRI, ultrasound)
    Wstępna ocena skuteczności: Punktacja w skalach funkcjonalnych (KOOS, Lysholm) oraz w badaniach obrazowych (MRI, USG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits: 2, 3, 4, 5, 6,
    Wizyty: 2, 3, 4, 5, 6,
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety and efficacy study
    Badanie bezpieczeństwa i skuteczności (Faza I/II)
    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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 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)
    Standard treatment
    Standardowe leczenie
    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 Decision2021-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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