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    The EU Clinical Trials Register currently displays   43932   clinical trials with a EudraCT protocol, of which   7307   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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    EudraCT Number:2022-002940-27
    Sponsor's Protocol Code Number:C2C-1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2022-002940-27
    A.3Full title of the trial
    Effect of adipose tissue derived mesenchymal stromal cells on autism and leaky gut syndrome.
    A phase I pilot study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stem cell treatment of autism spectrum disorders (ASD) and gastrointestinal problems in children.
    Stamcellebehandling af autismespektrumforstyrrelser (ASF) og mave-tarmproblemer hos børn.
    A.3.2Name or abbreviated title of the trial where available
    ASC - Autism Pilot Study
    A.4.1Sponsor's protocol code numberC2C-1
    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 SponsorCell2Cure ApS
    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 supportCell2Cure ApS
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCell2Cure ApS
    B.5.2Functional name of contact pointJens Kastrup
    B.5.3 Address:
    B.5.3.1Street AddressKajerødgård 9
    B.5.3.2Town/ cityBirkerød
    B.5.3.3Post code3460
    B.5.4Telephone number+4521202994
    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 AuthorisationDenmark
    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 nameCSCC_ASC
    D.3.2Product code CSCC_ASC5010
    D.3.4Pharmaceutical form Concentrate and solvent for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCSCC_ASC5010
    D.3.9.2Current sponsor codeCSCC_ASC5010
    D.3.9.3Other descriptive nameAllogeneic adipose tissue-derived mesenchymal stem cells expanded
    D.3.9.4EV Substance CodeSUB181445
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 million ASCs
    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. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Children with autism spectrum disorder and gastrointestinal symptoms.
    Børn med autismespektrumforstyrrelser og mave-tarmproblemer.
    E.1.1.1Medical condition in easily understood language
    Children with autism spectrum disorder and gastrointestinal symptoms.
    Børn med autismespektrumforstyrrelser og mave-tarmproblemer.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008520
    E.1.2Term Childhood autism
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10013225
    E.1.2Term Disorder gastrointestinal
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate safety and treatment effect of an allogeneic adipose tissue derived mesenchymal stromal cell product (CSCC_ASC) in children with autism spectrum disorder and gastrointestinal symptoms.
    At vurdere sikkerhed og behandlingseffekt af et stamcelleprodukt (CSCC_ASC) hos børn med autismespektrumforstyrrelse og mave-tarmproblemer.
    E.2.2Secondary objectives of the trial
    Not applicate.
    Ingen andre formål.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of autism spectrum disorder.
    Ongoing gastrointestinal symptoms or previous gastrointestinal symptoms which disappeared or were reduced after dietary changes.
    Age 6 – 14 years.
    Diagnose af autismespektrumforstyrrelser.
    Igangværende mave-tarmproblemer eller forhenværende mave-tarmproblemer som forsvandt eller blev reduceret efter kostændringer.
    Alder 6 – 14 år.
    E.4Principal exclusion criteria
    Known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder.

    Known CNS-infection (now or previously) and/or HIV positivity.

    Primary immunodeficiency disorder or autoimmune cytopenia.

    Current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other anti-inflammatory medication (except nonsteroidal anti-inflammatory drugs).

    Epilepsy or known seizure disorder (now or previously).
    Kendt genetisk syndrom eller patogen mutation eller kopiantalvariation associeret med autismespektrumforstyrrelser.

    Kendt CNS-infektion (nu eller tidligere) og/eller HIV-positivitet.

    Primær immundefekt eller autoimmun cytopeni.

    Nuværende behandling med cytotoksiske lægemidler eller systemisk glukokortikoider og/eller immunsuppressiv terapi eller anden antiinflammatorisk
    medicin (undtagen non-steroide antiinflammatoriske midler).

    Epilepsi eller kendt anfaldsforstyrrelse (nu eller tidligere).

    E.5 End points
    E.5.1Primary end point(s)
    Difference from baseline to follow-up within the group treated with CSCC_ASC:
    Safety within the 12 weeks follow-up period: AE, SAE, SUSAR and DSUR.
    Difference fra baseline til opfølgning indenfor gruppen behandlet med CSCC_ASC:
    Sikkerhed indenfor 12-ugers opfølgningsperiode: AE, SAE, SUSAR og DSUR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 uger
    E.5.2Secondary end point(s)
    Difference from baseline to follow-up within the group treated with CSCC_ASC:
    Changes in:

    - Autism spectrum disorder score test.
    - The Infant Gastrointestinal Symptom Questionnaire.
    - Faecal microbiota and short-chain fatty acid.
    - Biomarkers for inflammation, donor tissue type HLA antibodies, biomarkers for assessment of intestinal permeability and for immune cell
    Difference fra baseline til opfølgning indenfor gruppen behandlet med CSCC_ASC:
    Ændringer i:

    - Autismespektrumforstyrrelser score test.
    - Spædbørnsspørgeskema om mave-tarmproblemer.
    - Fækal mikrobiota og kortkædede fedtsyrer.
    - Biomarkører for inflammation, donorspecifikke HLA-antistoffer, biomarkører til vurdering af tarmpermeabilitet og for karakterisering af immunceller.

    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 uger
    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 Information not present in EudraCT
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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. trial design description
    Dose titrating
    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 trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    The trial will end when the last participant has had the last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F. of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 5
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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)
    Patients will be followed in their regular check-up.
    Patienter vil fortsat blive fulgt til deres sædvanlige kontrol.
    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 Decision2022-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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