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    Summary
    EudraCT Number:2016-002817-22
    Sponsor's Protocol Code Number:AAG-G-H-1624
    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:2017-02-08
    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 ConcernedGermany - PEI
    A.2EudraCT number2016-002817-22
    A.3Full title of the trial
    Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject plus in the Treatment of Cartilage Defects of the Knee
    Prospektive, multizentrische, einarmige klinische Phase III Prüfung zur Beurteilung der Wirksamkeit und Sicherheit von NOVOCART® Inject plus bei der Behandlung von Knorpelschäden im Knie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the efficacy and safety of NOVOCART® Inject plus in the treatment of cartilage defects of the knee.
    A.4.1Sponsor's protocol code numberAAG-G-H-1624
    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 Tissue Engineering Technologies - 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 Tissue Engineering Technologies - AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScope International AG
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressKonrad-Zuse-Ring 18
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68163
    B.5.3.4CountryGermany
    B.5.4Telephone number+496214293997
    B.5.5Fax number+496214293940
    B.5.6E-mailifueller@scope-international.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 Yes
    D.2.1.1.1Trade name NOVOCART® Inject
    D.2.1.1.2Name of the Marketing Authorisation holderTETEC AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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® Inject plus
    D.3.2Product code NInject plus
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracartilaginous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous Chondrocytes
    D.3.9.2Current sponsor codeNInject
    D.3.9.3Other descriptive nameAUTOLOGOUS HUMAN CARTILAGE CELLS
    D.3.9.4EV Substance CodeSUB30803
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2million cells/ml to 8million cells/ml
    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) Yes
    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 numberClassification: Tissue engineered product, combined ATMP Reference number: EMA/CAT/635656/2015
    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
    Repair of cartilage defects of the knee (medial or lateral femoral condyle or tibial plateau, trochlea or patella) caused by traumatic events or osteochondritis dissecans (defect size is ≥ 4 and ≤ 12cm²).
    E.1.1.1Medical condition in easily understood language
    Repair of cartilage defects of the knee.
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007702
    E.1.2Term Cartilage biopsy
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052913
    E.1.2Term Cartilage operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10007705
    E.1.2Term Cartilage damage
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057104
    E.1.2Term Cartilage repair
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064112
    E.1.2Term Cartilage graft
    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
    To demonstrate efficacy of NOVOCART® Inject plus for the treatment of cartilage defects of the knee based on the Knee injury and Osteoarthritis Outcome Score (KOOS) responder rate 24 month after transplantation.
    E.2.2Secondary objectives of the trial
    1. Further assessment of patients’ evaluation of efficacy of NOVOCART® Inject plus in terms of symptoms, function, quality of life and satisfaction with NOVOCART® Inject plus transplantation
    2. To assess the physicians’ evaluation of the functional efficacy of NOVOCART® Inject plus
    3. To evaluate cartilage (tissue-structure) regenerative effects of NOVOCART® Inject plus in a subgroup of 48 patients
    4. To assess the treatment failure rate and time to treatment failure
    5. To characterize the safe use of NOVOCART® Inject plus and the related surgical procedures
    Further objectives in this trial are to assess
    1. Durability of the treatment effect
    2. Long-term safety
    3. Health economics analyses
    4. Correlations between biological activity and quality and potency measurements (optional)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-operative inclusion criteria:
    At visit 1 patients must meet the following inclusion criteria for enrollment; all criteria must be answered with “yes” before the patient is scheduled for tissue harvest:
    1. Patient is ≥ 18 and ≤ 65 years old at screening. Pediatric patients (14 to 17 years) with closed epiphysis may be included in selected countries. Closure of the distal femoral epiphysis of the target knee needs to be confirmed by MRI or x-ray.
    2. Patients with focal articular cartilage defect(s) of the femoral condyle (medial or lateral), the trochlea, the patella or the tibial plateau (medial or lateral) of the knee.
    3. Patient has one or two defects in the target knee with a defect-grade of III or IV according to the International Cartilage Repair Society (ICRS) classification or grade III or IV ICRS classification of osteochondritis dissecans lesions (ICRS-OCD).
    4. If the patient has only one grade III or IV defect, the size of the defect is ≥ 4 and ≤ 12 cm2 post debridement. If the patient has two grade III or IV cartilage defects the total defect size is ≥ 4 and≤ 12 cm2 post debridement. The defects must be located on different knee joint areas and both cartilage defects are to be treated with NOVOCART® Inject plus.
    5. Patient has an intact, well-contained chondral structure surrounding the defect (i.e. no diffusely thinned-out cartilage surface) and an intact articulating joint surface opposite to the defect(s) to be treated (≤ Grade I ICRS or ICRS-OCD classification).
    6. Patient has intact menisci in the target knee; a maximum of 50% resection per meniscus is allowed. Completely healed meniscal transplants are accepted.
    7. Patient has a stable knee joint or sufficiently reconstructed ligaments and no patella malalignment or a sufficiently corrected patella malalignment. Ligament repair is accepted, if performed before, during or within 6 weeks after NOVOCART® Inject plus transplantation. Correction of patella malalignment must be performed before or during NOVOCART® Inject plus transplantation.
    8. Patient has free range of motion (ROM) of the affected knee joint or ≤ 10° of active extension and flexion loss (compared to the other knee).
    9. Patient has a baseline score of < 65/100 in the overall KOOS (KOOS5).
    10. Only for female patients of childbearing potential (sexually mature, pre-menopausal and not surgically sterile): the patient is willing to use a medically accepted method of contraception until the day of NOVOCART® Inject plus transplantation.
    11. Patient is willing and able to give written informed consent to participate in the study and to comply with all follow-up visits and assessments and the postoperative rehabilitation program.
    Intraoperative inclusion criteria:
    At visit 2, the following inclusion criteria from visit 1 need to be confirmed; all criteria must be answered with “yes” before the patient is considered eligible for the study:
    1. Patient is not pregnant as confirmed by urine pregnancy test before arthroscopy
    2. Patients with focal articular cartilage defect(s) of the femoral condyle (medial or lateral), the trochlea, the patella or the tibial plateau (medial or lateral) of the knee.
    3. Patient has one or two defects in the target knee with a defect-grade of III or IV according to the International Cartilage Repair Society (ICRS) classification or grade III or IV ICRS classification of osteochondritis dissecans lesions (ICRS-OCD).
    4. If the patient has only one grade III or IV defect, the size of the defect is ≥ 4 and ≤ 12 cm2 post debridement. If the patient has two grade III or IV cartilage defects the total defect size is ≥ 4 and ≤ 12 cm2 post debridement. The defects must be located on different knee joint areas and both cartilage defects are to be treated with NOVOCART® Inject plus.
    5. Patient has an intact, well-contained chondral structure surrounding the defect (i.e. no diffusely thinned out cartilage surface) and an intact articulating joint surface opposite to the defect(s) to be treated (≤ Grade I ICRS or ICRS-OCD classification).
    6. Patient has intact menisci; a maximum of 50% resection per meniscus is allowed. Completely healed meniscal transplants are accepted.
    E.4Principal exclusion criteria
    Pre-operative exclusion criteria (most important listed):
    At visit 1 none of the following exclusion criteria must apply to any eligible patient; all criteria must be answered with “no” before the patient is scheduled for tissue harvest:
    1. Patient is unable to undergo magnetic resonance imaging (MRI).
    2. Patient has grade II cartilage defects according to the ICRS or ICRS-OCD classification in the target knee.
    3. Patient has more than 2 grade III or IV cartilage defects according to the ICRS or ICRS-OCD classification in the target knee.
    4. The cartilage defects (ICRS or ICRS-OCD grade I or III or IV) affect more than 3 out of 6 joint areas1 of the target knee.
    5. Patient had a prior biologic reconstructive procedure (e.g. microfracture, mosaicplasty, chondrocyte transplantation) in the target knee at a location different from the defect location to be treated in the study. Prior biologic reconstructive procedures are accepted, if the previously treated defect is the same defect that is planned to be treated with NOVOCART® Inject plus (i.e. the prior method has failed) and these procedures were performed ≥ 24 months prior to screening visit 1.
    6. Patient had other prior surgical interventions interfering with the assessment of the NOVOCART® Inject plus treatment. Prior diagnostic arthroscopies with debridement and lavage are acceptable.
    7. Patients with subchondral bone defects more than 2 mm deep (after resection of affected bone) unless adjuvant defect filling will be performed before or during NOVOCART® Inject plus transplantation.
    8. Patient has degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2.
    9. Patient has chronic inflammatory arthritis and/or infectious arthritis.
    10. Patient has joint space narrowing > 1/3 in the target knee when compared to the other knee or < 3 mm joint space.
    11. Patient has malalignment (valgus- or varus-deformity) in the target knee.
    12. Patient has arthrofibrosis in the target knee.
    13. Patient has diffuse chondromalacia (grade 1 ‘softening or swelling of cartilage’ according to Outerbridge allowed).
    14. Patient has metabolic arthropathies (e.g. gout, pseudo-gout)
    15. Patient has bilateral lower limb pain or low back pain.
    16. Patient has a known systemic connective tissue disease.
    17. Patient has a current uncontrolled diabetes.
    18. Patient has a known history of autoimmune disease.
    19. Patient has a known history of immunological suppressive disorder or is taking immunosuppressants.
    20. Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the last 30 days prior to screening visit 1.
    21. The patient has a history of Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS), Human T cell lymphotropic virus (HTLV), syphilis (Treponema pallidum) or active hepatitis B or C (HCV) infection with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
    22. The patient has a history of borreliosis.
    23. The patient has an active systemic or local (at the site of surgery) infection, eczematization or inflammable skin alterations.
    25. Patient has a known history of osteoporosis, uncontrolled primary hyperparathyroidism or hyperthyroidism, chronic renal failure or prior pathological fractures independent of the genesis.
    26. 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 (ALS), or multiple sclerosis (MS).
    27. Patient has a body mass index (BMI) > 35 kg/m2.
    32. Patient has a known intolerance to any constituents of NOVOCART® Inject plus.
    33. Patient has comorbidities preventing the patient from undergoing surgery
    Intraoperative exclusion criteria:
    At visit 2, the following exclusion criteria from visit 1 need to be confirmed; all criteria must be answered with “no” before the patient is considered eligible for the study:
    1. Patient has grade II cartilage defects according to the ICRS or ICRS-OCD classification in the target knee.
    2. Patient has more than 2 grade III or IV cartilage defects according to the ICRS or ICRS-OCD classification in the target knee.
    3. The cartilage defects (ICRS or ICRS-OCD grade I or III or IV) affect more than 3 out of 6 joint areas2 of the target knee.
    4. Patients with subchondral bone defects more than 2 mm deep (after resection of affected bone) unless adjuvant defect filling will be performed before or during NOVOCART® Inject plus transplantation.
    5. Patient has arthrofibrosis in the target knee.
    6. Patient has diffuse chondromalacia (grade 1 ‘softening or swelling of cartilage’ according to Outerbridge allowed).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this trial is the responder rate based on the Knee injury and Osteoarthritis Outcome Score (KOOS5) defined as the average of the 5 subscale scores (ensuring identical weight from all subscales) at the 24 months follow-up assessment. The KOOS5 responder rate is defined as the proportion of patients with ≥ 10 points improvement in the KOOS5 from baseline to the 24 months visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24-months follow-up assessment
    E.5.2Secondary end point(s)
    1. Change in the KOOS5 from baseline to the 24 months assessment
    2. Change in the 5 individual subscores of the KOOS from baseline to the 24 months assessment
    3. Change from baseline in the International Knee Documentation Committee (IKDC) subjective score from baseline to the 24 months assessment
    4. IKDC subjective score responder rate, defined as the proportion of patients with > 20.5 points improvement in the IKDC subjective score from baseline to the 24 months visit
    5. Change from baseline to the 24 months visit in the EQ-5D-5L question¬naire
    6. Change from baseline to the 24 months visit in activity level/ functional status
    7. Patient satisfaction with treatment 24 months after NOVOCART® Inject plus transplantation
    8. Change from baseline to the 24 months visit in the grading according to the IKDC surgeons part
    9. In vivo performance measured by the 24 months morphological assessment of the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score and biochemical MR assessement by T2 mapping in a subgroup of 48 patients
    10. Treatment failure rate: intraoperatively diagnosed treatment failures are defined as all surgical re-interventions affecting the closed surface of the transplant area (the surface is not closed when the defect area is grade 3 or 4 ICRS) and/or require additional cartilage repair modalities on the target defect. Explanatory note: (1) Removal of hypertrophic tissue is not regarded as treatment failure unless the closed graft surface is affected. (2) Correction of insufficient graft integration, e.g. by microfracturing the gap between graft and surrounding cartilage of the originally treated defect, is regarded as treatment failure. (3) Treatment of adjacent defects to the originally treated defect is no treatment failure.
    11. Time to treatment failure
    12. Treatment-related adverse events (AEs) from baseline to the 24 months assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to point E.5.2
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Germany
    Hungary
    Lithuania
    Poland
    Switzerland
    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 days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months7
    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: 7
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 86
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    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)
    Standard treatment and care for the condition
    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 Decision2017-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-22
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