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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2010-023830-22
    Sponsor's Protocol Code Number:AAG-G-H-1102
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-15
    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 number2010-023830-22
    A.3Full title of the trial
    NDisc Study: A Prospective Randomized Multicentre Phase I / II Clinical Trial to Evaluate Safety and Efficacy of NOVOCART® Disc plus Autologous Disc Chondrocyte Transplantation (ADCT) in the Treatment of Nucleotomized and Degenerative Lumbar Discs to Avoid Secondary Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NOVOCART® Disc plus Autologous Disc Chondrocyte Transplantation (ADCT) in the Treatment of Lumbar Discs
    A.3.2Name or abbreviated title of the trial where available
    NDisc Study
    A.4.1Sponsor's protocol code numberAAG-G-H-1102
    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 SponsorTETEC AG
    B.1.3.4CountryGermany
    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 supportTETEC AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTETEC AG
    B.5.2Functional name of contact pointSimone Steinert, Study Manager
    B.5.3 Address:
    B.5.3.1Street AddressAspenhaustr. 18
    B.5.3.2Town/ cityReutlingen
    B.5.3.3Post code72770
    B.5.3.4CountryGermany
    B.5.4Telephone number0049071211626 203
    B.5.5Fax number0049071211626 249
    B.5.6E-mailsimone.steinert@tetec-ag.de
    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 nameNOVOCART® Disc plus
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradiscal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDisc Chondrocytes
    D.3.9.3Other descriptive nameDisc Chondrocytes
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.9 to 1.1
    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) Yes
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntradiscal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The subject has a disc herniation with back and /or leg pain (radicular pain) and an identification for sequestrectomy according to the guidelines of DGNC and DGOOC.
    E.1.1.1Medical condition in easily understood language
    Herniated lumbar disc with indication for surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10022634
    E.1.2Term Intervertebral disc disorders
    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
    • To characterize the cumulative functional and radiographic effects of NDplus over NDbasic and SC.
    • To characterize the effect of NDbasic alone over SC.
    • To characterize the safely use of the investigational product and the transplan-tation/implantation procedures.
    • To characterize the effect of the investigational product on the adjacent de-generative discs.
    • To define metabolic parameters that measure identity, purity, and potency of the extracted tissue, of the isolated cells, and of the in vitro expanded cells.
    • To define metabolic parameters in subjects to control the status of tissue repair.
    • To define the prognostic value of metabolic and radiographic parameters in the context of disc degeneration, functional status, and quality of life.
    E.2.2Secondary objectives of the trial
    • To quantify parameters of surgical procedures.
    • To evaluate the sensitivity and effectiveness of methods in measuring the treatment effects.
    • To estimate the variability in outcomes.
    • To gauge physician acceptability and ease of use of the investigational product.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In vivo biochemical 3T and 7T MR Imaging for in vivo monitoring of patients after autologous disc chondrocyte transplantation (ADCT)
    E.3Principal inclusion criteria
    1. The patient has a disc herniation with back and/or leg pain (radicular pain)
    2. The patient has an indication for sequestrectomy according to the guidelines of DGNC and DGOOC (Börm, Steiger, Papavero, Herdmann, Ohmann, & Schwedtfeger, 2005.
    3. The patient is between 18-60 years of age.
    4. The patient is physically and mentally able to participate in the study, and is able to understand the study, its goals and the possible risk factors involved. The patient is willing and able to participate in the follow-up visit plan at the study site and is able to understand and to complete study-relevant questionnaires in German language.
    5. The patient is sufficiently informed about this trial orally and in writing. S/he had enough time for consideration, is willing to participate in the study and gives her/his written informed consent.
    6. The patient confirms that s/he did not participate in a clinical study 90 days prior study inclusion. S/he agrees to refrain from participating in another clinical study during the NOVOCART® Disc Study and for another 90 days after study termination

    Radiological Inclusion Criteria
    1. The patient has a single-level lumbar disc herniation
    2. The patient has more than 50% remaining disc height in the herniated disc in comparison to unaffected discs in the lumbar spine. If all discs show degenerative signs, disc height has to be at least 5 mm
    3. The patient has no obvious signs of osteophytes and no endplate sclerosis in the lumbar segment to be treated with NOVOCART® Disc plus or NOVOCART® Disc basic
    • Patients without adjacent degenerative disc (HD):
    4. The adjacent proximal disc has no degenerative signs according to Pfirrman Score stage 3 to 5.
    • Patients with adjacent degenerative disc (AAD):
    4. The patients has additional degenerative signs in the proximal adjacent lumbar level according to Pfirrmann 3-4, but no more than 25% disc height reduction
    E.4Principal exclusion criteria
    1. The patient has had a previous surgery at the lumbar level(s) and has been treated with NOVOCART® Disc plus or NOVOCART® Disc basic.
    2. The patient had a past recurrent disc herniation treated with nucleotomy/sequestrectomy of the relevant disc .
    3. The patient has any degenerative muscular or neurological condition that would interfere with evaluation of outcome measures including but not limited to Parkinson’s disease, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy and myelopathic diseases of different causes.
    4. BMI > 35 kg/m2
    5. The patient has current or recent history of illicit drug, nicotine (more than 20 cigarettes per day) or alcohol abuse or dependence
    6. CRP > 10mg/dl
    7. The patient is pregnant, breastfeeding or actual planning to become pregnant. Female patients must be either at least two years postmenopausal or using one of the following means of birth control during the treatment phase, i.e. to transplantation
    o surgical sterility
    o double barrier methods, e.g. condom or diaphragm in combination with spermicide
    o intrauterine contraceptive device
    o bilateral vasectomy of sexual partner at least 90 days prior to enrolment in combination with barrier methods (e.g. condom or diaphragm)
    o birth control pill
    8. The patient has a history of known allergies or a suspicion of allergies to any of the NOVOCART® Disc plus or basic product components including hyaluronan, polyethylenglycol or albumin
    9. Immune defects or the affinity for infections of known or unknown causes
    10. The patient has a active systemic or local microbial infection, eczematization or inflammable skin alterations at the site of surgery (including Protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-Disease), Leishmaniasis, persistent bacterial infections, like Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy, Recurrent Fever, Melioidosis or Tularaemia).
    11. The patient is unable to undergo magnetic resonance imaging (MRI)
    12. The patient has a history or a suspicion of a disease with chronically inflammable character, as rheumatoid arthritis, gout, pseudo-gout, metabolic bone diseases, Crohn’s disease, ulcerative colitis, lupus erythemathosus, or other autoimmune disorders
    13. Known osteoporosis
    14. The patient has a primary hyperparathyroidism or hyperthyroidism, has chronic renal failure or has had previous fragility fractures.
    15. Systemic connective tissue or collagen disease
    16. Hereditary ocular degenerations with unclear diagnosis, retinopathies based on connective tissue-defined causes, macular corneal dystrophy, (based on the fact that the human cornea expresses cartilage specific proteins as essential functional elements and thus may serve as an indicator for paralleling degenerative events in various cartilaginous tissues)
    17. The patient has immune suppression
    18. The patient has a history of blood coagulation disease of different genesis, including known haemorrhagic diathesis of unknown cause
    19. The patient had undergone chemo or radiotherapy within the past 5 years, or had any
    cancer other than non-melanoma skin cancer treated with curative intent within the past
    5 years
    20. Known diabetes, drug treated
    21. Ulterior concomitant diseases or functional impairments of specific organs, which
    exclude study participation by the assessment of the investigator
    22. The patient is a prisoner

    Radiological Exclusion Criteria
    1. The patient has apparent degenerative changes in the lumbar spine as determined by Modic Changes 2-3
    2. The patient has one or more dysplastic vertebral bodies within the lumbar spine
    3. The patient has a sacralised lumbar vertebra LWK5 at the level to be treated with NOVOCART® Disc plus or NOVOCART® Disc basic
    4. The patient has previous or acute spondylodiscitis
    5. Segmental instability (spondylolisthesis > 5 mm) or translation > 3 mm
    6. The patient has a isthmic spondylolisthesis, ankylosing spondylitis or spondylolysis
    7. The patient has lumbar scoliosis (> 11° deformation).
    8. The patient has previous trauma, discography or any other surgical intervention at the lumbar spine .
    9. The patient has previous compression or burst fracture at the level(s) to be treated with NOVOCART® Disc plus or NOVOCART® Disc basic
    10. The patient has a central spinal canal stenosis with evidence of a narrowing of < 8 mm (by MRI, sagital )
    11. The patient has a spinal tumor
    12. The patient has metabolic bone disease
    13. The patient has facet ankylosis or severe facet degeneration.
    14. The patient has a lumbar kyphosis

    Intra-surgery (tissue explant) Exclusion Criteria
    1. Extensive damage of the Anulus, which subsequently poses a significantly greater risk of
    recurrence.

    Exclusion criteria after tissue explant
    1. HIV infection
    2. Treponema pallidum (syphilis) infection
    3. active hepatitis B or C infection

    Exclusion Criteria prior Transplantation
    1. Recurrent disc herniation after surgery and prior transplantation/implantation
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    - Prevalence of subsequent surgical interventions.

    - Summary of all reported adverse events by event category, intensity, seriousness, and relationship to the graft and/or procedure.

    - Unexpected Adverse Reaction

    - Specific laboratory parameters according to product compatibility and availability (only in Phase I): CRP, IL-6, LTE-4

    Phase II:
    Oswestry Disability Index (Primary Efficacy Variable)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I:
    Blood tests (CRP, IL-6, LTE-4) at sequestrectomy, 2h, 6h, 24h, 36h post sequestrectomy, before transplant, 6h, 48h, 3 weeks and 6 weeks post transplant

    MRI: baseline, direct before transplant, 48h, 3weeks, 6weeks post transplant

    Phase II:
    baseline, transplant, 1.5, 3, 6, 12, 24, 36, 48 and 60 months post transplant
    E.5.2Secondary end point(s)
    Phase II:
    - T2 Relaxation Time
    - MRI-signal (disc height, disc volumetry, signal intensity)
    - Oswestry Disability Index
    - VAS for back pain and leg pain
    - Health-related quality of life as measured by the SF-36
    - Functional status
    - Neurological status
    - Return to work (days)
    - Analgesic Medication Use
    - Healthy Questionnaire EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, transplant, 1.5, 3, 6, 12, 24 and 60 months post transplant
    (no MRI at 3 month post transplant)

    Oswestry Disability Index additionally at 36 and 42 months post transplant via telephone interview.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    standard care
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months5
    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: 120
    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 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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    The treatment ends after sequestrectomy in the SC study arm and after transplant of the investigational product in the NDbasic and NDplus study arm. Further patient treatment will be according to the guidelines of DGNC and DGOOC.
    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 Decision2012-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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