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Trial record 9 of 29 for:    Open Studies | "Cartilage, Articular"

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture to Treat Cartilage Defects of the Knee (N3D)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Tetec AG
Sponsor:
Information provided by (Responsible Party):
Tetec AG
ClinicalTrials.gov Identifier:
NCT01656902
First received: July 20, 2012
Last updated: October 19, 2016
Last verified: October 2016
  Purpose

For the cartilage cell product NOVOCART® 3D plus, which is used in the study described here, the company TETEC AG obtained an expanded production authorization from the medication monitoring authorities in compliance with Section 13, Para. 1 of the Medicinal Products Act in 2003. This entitles TETEC AG to produce the pharmaceutical product and already distribute it. More than 6000 patients were already successfully treated with NOVOCART® 3D in Europe since 2003. In order to obtain a general market authorization for NOVOCART® 3D plus, this control group study is conducted, in which the superiority of the safety and effectiveness of carrier-bound Autologous Chondrocyte Transplantation with NOVOCART® 3D plus compared to the standard of care microfracture surgery needs to be proven. This study further aims at developing and validating known and new biologic markers for the quality and clinical efficacy of the product as requested in the context of identity, purity and potency characteristics of the medicinal/investigational product.

The patients will receive one of the therapeutic procedures in the study. The treatment procedure which will be used will be decided by a previously specified random process. This type of study meets the high quality requirements of the statutorily specified safety and quality regulations which are also referred to as "Good Clinical Practice" (GCP). The probability of the patient being allocated to one of the two treatments is 2:1; that is, an approx. 67% probability of therapy with NOVOCART® 3D plus and an approx. 33% probability of therapy with microfracture. Neither the patient, nor the investigator will be able to influence the treatment assignment.

Patients will be screened for eligibility at the Screening Visit. Each patient will remain in the study for 36 months post-implant for the effectiveness assessments, and then an additional two years to complete the planned post-market phase. Each patient will be in the study for up to five years.

Cells and tissues collected from this study will be used in other in vitro-controlled experiments aimed at developing and validating known and novel biologic markers to quantify cell quality in the context of identity, purity and potency. Prognostic values of these biologic markers will be examined by correlating them with clinical data collected in this study.


Condition Intervention Phase
Traumatic Articular Cartilage Defects in the Knee Joint
Drug: NOVOCART® 3D plus
Procedure: Microfracture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee

Further study details as provided by Tetec AG:

Primary Outcome Measures:
  • Subjective IKDC score [ Time Frame: Baseline assessment to 24-month follow-up assessment ] [ Designated as safety issue: No ]

    The primary endpoint is the change from baseline in the "2000 International Knee Documentation Committee" (IKDC) subjective score to 24-month visit.

    The IKDC will be recorded for NOVOCART® 3D plus and microfracture patients at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.



Secondary Outcome Measures:
  • IKDC objective physician score [ Time Frame: Baseline assessment to 24-month follow-up assessment ] [ Designated as safety issue: No ]

    The IKDC objective physician score will be recorded for both arms at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments. A sequentially rejecting, hierarchical test procedure will be employed to test these secondary endpoints in the a-priori defined order given here after the test primary efficacy variable was passed.

    The change from baseline to the 24-month visit in the IKDC objective physician score and from baseline to the 24-month visit will be evaluated.


  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline assessment to 24-month follow-up assessment ] [ Designated as safety issue: No ]

    The KOOS will be recorded for both arms at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.

    A sequentially rejecting, hierarchical test procedure will be employed to test these secondary endpoints in the a-priori defined order given here after the test primary efficacy variable was passed. The change from baseline to 24-month visit in the Knee Injury and Osteoarthritis Outcome Score (KOOS) and from baseline to 24-month visit will be evaluated.


  • MOCART Score (MRI) [ Time Frame: Baseline assessment to the 24-month assessment ] [ Designated as safety issue: No ]

    Another secondary efficacy endpoint is the in vivo performance (grading on quality of cartilage fill) measured by the change from baseline to the 36-month assessment of the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. These assessments will be performed on a subset of patients (64 in NOVOCART and 32 in microfracture arm).

    The MRI will be recorded at 3, 12, 24 and 60 months follow-up visit.


  • Health-related quality of life as measured by the SF-36 survey [ Time Frame: Baseline assessment to 24-month follow-up assessment ] [ Designated as safety issue: No ]
    Another secondary efficacy endpoint is the change from baseline to the 24-month visit in the SF-36 to measure clinical utility and summarize health-related quality-of-life and cost-effectiveness. The SF-36 will be recorded for NOVOCART® 3D plus and microfracture patients at baseline visit 1 and at the 6 weeks, 3-, 6-, 12-, 24-, 36-, 48,- and 60-month follow-up assessments.

  • Surgical time (cut-to-suture time) [ Time Frame: Transplantation (24 +-5 days post-arthroscopy) and/or arthroscopy (>= 1 day after screening), depending on the study arm ] [ Designated as safety issue: No ]
    The surgical time will be measured in minutes and recorded for NOVOCART® 3D plus patients at arthroscopy (>= 1 day after screening) and transplantation (24 +-5 days post-arthroscopy); for microfracture patients surgical time will be measured in minutes and recorded at arthroscopy (>= 1 day after screening).

  • Length of incision [ Time Frame: Only for verum group at transplantation (24 +-5 days post-arthroscopy) ] [ Designated as safety issue: No ]
    The length of incision will be measured in cm and recorded for NOVOCART® 3D plus patients at transplantation (24 +-5 days post-arthroscopy)

  • Any unanticipated adverse event [ Time Frame: Baseline assessment up to 60-months follow-up assessment ] [ Designated as safety issue: Yes ]

    Event descriptions, onset, resolution dates, relationship to the IP and procedures of any AEs will be recorded. Each event will be categorized by seriousness and intensity to facilitate complete safety reporting throughout the trial.

    While comparisons between treatment groups can be made for each class of AE, there is no statistical hypothesis governing acceptance of this endpoint at the end of the clinical study because of the different AE profiles associated with the two treatment arms.


  • Treatment Failure [ Time Frame: From completion of study treatment until 60-months follow-up assessment ] [ Designated as safety issue: Yes ]
    Any event related to a diagnosed failure of the study treatment


Estimated Enrollment: 261
Study Start Date: January 2013
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N3D plus
NOVOCART® 3D plus (Autologous Chondrocyte Transplantation System)
Drug: NOVOCART® 3D plus
Two-Step intervention: 1) cartilage cells are collected from the patient during arthroscopy 2) collected cartilage cells are cultivated in a sterile environment, seeded in an organic matrix scaffold and implanted into the defect location (knee, femur)
Other Name: Matrix-associated autologous chondrocyte implantation
Active Comparator: Microfracture
Microfracture is the standard care surgery.
Procedure: Microfracture
single-step treatment: defect location (knee, femur) is debrided, then bone plate is drilled mechanically to allow cells from the bone marrow to move to the defect location and to develop a scar tissue
Other Name: Microfracture according to Steadman

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is between 18 and 65 years old at screening.
  2. Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is ≤ 6 cm2 and the size of each individual lesion is ≥ 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART 3D plus or microfracture.
  3. Patient has a defect size is between 2 and 6 cm2. Note: defect size can be estimated by MRI at visit 1 if no data is available from medical history.
  4. Patient has an intact articulating joint surface (not higher than Grade 2 International Cartilage Repair Society classification, no kissing lesions). Note: ICRS classification can be estimated by MRI at visit 1 if no data is available from medical history.
  5. Patient has an intact meniscus; a maximum of 50% resection is allowed. Note: status of meniscus can be estimated at visit 1 if no data is available from medical history.
  6. Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair must be done before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
  7. Patient has free range of motion of the affected knee joint or ≤ 10° of extension and flexion loss.
  8. Patient has a defect-grade of III or IV according to the ICRS classification. Note: ICRS classification can be estimated by MRI at visit 1 if not data is available from medical history.
  9. Patient has a baseline score of 60/100 on the 2000 International Knee Documentation Committee (IKDC) subjective knee evaluation.
  10. Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and postoperative rehabilitation regimen.
  11. Mandatory for France only: Patient benefits of a health insurance regimen.

Exclusion Criteria (pre-operative):

  1. Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
  2. Patient is unable to undergo magnetic resonance imaging (MRI).
  3. Patient has prior surgical treatment of the target knee using mosaicplasty, autologous chondrocyte transplantation and/or microfracture. Note: prior diagnostic arthroscopies with debridement and lavage are acceptable. Ligament repair is accepted, if performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
  4. Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade > 2 (see Appendix A).
  5. Patient has chronic inflammatory arthritis and/or infectious arthritis.
  6. Patient has joint space narrowing > 1/3 in the target knee when compared to the other knee or smaller than 3 mm joint space measured on x-ray.
  7. Patient has malalignment (valgus- or varus-deformity) in the target knee. Note: In suspected cases, the mechanical axis must be established radiographically by complete leg imaging in standing position and in a.p. or rather p.a. projection. The Mikulicz line is not allowed to deviate more than 5 mm of the eminentia intercondylaris. If alignment is necessary, surgery has to be performed before, during or within 6 weeks after cartilage treatment (ACT/microfracture).
  8. Patient has prior surgical treatment of clinical relevance of the target knee.
  9. Patient has an osteochondral defect.
  10. Patient has bilateral lower limb pain or low back pain.
  11. Patient has a known systemic connective tissue disease.
  12. Patient has a current uncontrolled diabetes.
  13. Patient has a known history of autoimmune disease.
  14. Patient has a known history of immunological suppressive disorder or is taking immunosuppressants.
  15. Patient is currently systemically or intra-articularly taking steroids and/or has used steroids within the last 30 days prior to screening visit 1.
  16. The patient has a history of HIV/AIDS.
  17. The patient has a history of syphilis (Treponema pallidum).
  18. The patient has an active hepatitis B or C infection with verified antigens. Note: Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
  19. The patient has at the site of surgery an active systemic or local microbial infection, eczematization or inflammable skin alterations (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).
  20. Patient has a known history of cancer within the past 5 years.
  21. Patient has a known history of osteoporosis; also patients with primary hyperparathyroidism or hyperthyroidism without satisfactory treatment, chronic renal failure or patients with prior pathological fractures independent of the genesis are excluded.
  22. 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).
  23. Patient has a body mass index (BMI) higher than 35 kg/m2.
  24. Patient is a woman who is pregnant or lactating. Note: contraception is indicated for female patients of childbearing potential until the day of cartilage treatment. Female patients who are unwilling to practice a medically acceptable method of birth control until the day of cartilage treatment cannot be included.
  25. Patient is currently participating, or has participated in any other clinical study within 3 months prior to the screening visit.
  26. Patient has known current or recent history of illicit drug or alcohol abuse or dependence
  27. Patient has psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the patient's ability to comply with the study requirements, e.g., Alzheimer's disease.
  28. Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study.
  29. Mandatory for France only: patients tested positive for Human T-Cell Lymphotropic Virus Types 1 or 2 (HTLV-1 or 2)

Intra-operative Inclusion Criteria:

  1. Patient is not pregnant as confirmed by urine pregnancy test before arthroscopy.
  2. Patient has a localized articular cartilage defect of the femoral condyle or the trochlea of the knee. 2 localized cartilage defects are accepted if the total defect size is up to 6 cm2 and the size of each individual lesion is at least 2 cm2, both cartilage defects are located at the femoral condyle and/or the trochlea and both cartilage defects are to be treated with NOVOCART 3D plus or microfracture.
  3. Patient has a defect size of 2 to 6 cm2 post-debridement.
  4. Patient has an intact articulating joint surface (at least (or higher) Grade 2 International Cartilage Repair Society classification) no kissing lesions).
  5. Patient has an intact meniscus; a maximum of 50% resection is allowed (no indication for concurrent meniscus transplant).
  6. Patient has a stable knee joint or sufficiently reconstructed ligaments. If not, ligament repair must be done during or within 6 weeks after cartilage treatment (ACT/microfracture).
  7. Patient has a defect grade of III or IV according to the ICRS classification.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656902

Contacts
Contact: Thomas Gwinner, Dr +49 7121 16 26 204 thomas.gwinner@tetec-ag.de
Contact: Alexandra Kirner, Dr +49 7121 16 26 201 alexandra.kirner@tetec-ag.de

Locations
Austria
Privatklinik Doebling Recruiting
Vienna, Austria, 1190
Contact: Stefan Marlovits, Prof.    004313608000    office@marlovits.at   
Contact: Stefanie Trulp    00436503366000    stefanie.trulp@gmail.com   
Principal Investigator: Stefan Marlovits, Prof         
Medizinische Universität Wien Withdrawn
Wien, Austria, 1090
Czech Republic
Fakultni nemocnice Brno - Ortopedicka klinika Recruiting
Brno, Czech Republic, 62500
Contact: Martin Repko, Ass. Prof    00420532232704    repko@seznam.cz   
Contact: Tomas Otasevic, MD    00420605440056    totasevic@email.cz   
Principal Investigator: Martin Repko, Ass. Prof         
Sub-Investigator: Tomas Otasevic, MD         
Urazova nemocnice v Brne - Traumatologie Recruiting
Brno, Czech Republic, 66250
Contact: Libor Pasa, Ass. Prof    00420602745834    L.Pasa@seznam.cz   
Contact: josef Prokes, MD    00420774207666    josefprokes@gmail.com   
Principal Investigator: Libor Pasa, Ass. Prof         
Sub-Investigator: Josef Prokes, MD         
NH Hospital, a.s., Ortopedicke oddeleni nemocnice Horovice Recruiting
Horovice, Czech Republic, 26831
Contact: Milan Pastucha, MD    00420702009477    stricak@yahoo.com   
Contact: Petr Capek, MD    00420776572268    capp@seznam.cz   
Principal Investigator: Milan Pastucha, MD         
Sub-Investigator: Petr Capek, MD         
Fakultni nemocnice Hradec Kralove - Ortopedicka klinika Recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Jaroslav Pavlata, MD    00420604787830    jaroslav.pavlata@fnhk.cz   
Contact: Libor Prokes, MD       linor.prokes@fnhk.cz   
Principal Investigator: Jaroslav Pavlata, MD         
Sub-Investigator: Libor Prokes, MD         
Pardubicka nemocnice Recruiting
Pardubice, Czech Republic, 53203
Contact: Petr Hoza, MD    00420775785616    petr.hoza@nempk.cz   
Contact: Pavel Kout, MD       pavel.kout@nempk.cz   
Principal Investigator: Petr Hoza, MD         
Fakultni nemocnice v Motole Recruiting
Praha, Czech Republic, 15006
Contact: Martin Hanus, MD    00420776099310    mar.doc21@gmail.com   
Contact: Milan Handl, Prof       milanhandl@seznam.cz   
Principal Investigator: Milan Handl, Prof         
Sub-Investigator: Martin Hanus, MD         
UVN - Vojenska fakultni nemocnice Praha Not yet recruiting
Praha, Czech Republic, 16902
Contact: Antonin Chochola, MD    00420604635435    antonin.chochola@uvn.cz   
Principal Investigator: Antonin Chochola, MD         
France
Hôpital Ambroise Paré - Service de Chirurgie Orthopedique et Traumatologie Recruiting
Boulogne Billancourt, France, 92104
Contact: Philippe Hardy, Prof    0033149095488    philippe.hardy@apr.aphp.fr   
Contact: Claudine Martinet    0033149095564    claudine.martinet@ahphp.fr   
Principal Investigator: Philippe Hardy         
Sub-Investigator: Erwin Pansard         
Polyclinique Saint-Roch Recruiting
Montpellier, France, 34075
Contact: Marion Bertrand-Marchand, MD    0033688248881    marion.dr-marchand@wanadoo.fr   
Contact: Angela Kachouri    0033467618827    a.kachouri@cl-st-roch.fr   
Principal Investigator: Marion Bertrand-Marchand, MD         
Clinique V - Clinique du Sport Recruiting
Paris, France, 75005
Contact: Yoann Bohu, MD    0033140794036    yoann.bohu@orange.fr   
Contact: Catherine Saint Eloi    0033140794064    c.sainteloi@ramsaygsante.fr   
Principal Investigator: Yoann Bohu         
Clinique de Maussins Withdrawn
Paris, France, 75019
CHU de Saint-Etienne Hôpital Nord - Service orthopedie et traumatologie Recruiting
Saint-Priest-En-Jarez, France, 42270
Contact: Remi Philippot, Prof    0033477120824    remi.philippot@chu-st-etienne.fr   
Contact: Jean-Yves de Lemps    0033477127787    j.yves.delemps@chu-st-etienne.fr   
Principal Investigator: Remi Philippot, Prof         
Germany
Universitaetsklinikum Freiburg - Klinik fuer Orthopaedie Recruiting
Freiburg im Breisgau, Germany, 79106
Contact: Philipp Niemeyer, Professor    0049 761 270 24010    philipp.niemeyer@uniklinik-freiburg.de   
Contact: Alexandra Brueggen    0049 761 270 26330    alexandra.brueggen@uniklinik-freiburg.de   
Principal Investigator: Philipp Niemeyer, Prof         
Sub-Investigator: Tayfun Yilmaz, MD         
Theresienkrankenhaus Active, not recruiting
Mannheim, Germany, 68165
Orthopädische Klinik und Poliklinik der LMU München Recruiting
Muenchen, Germany, 81377
Contact: Peter Müller, Prof.    +49 (0)8 97 09 53 781    peter.mueller@med.uni-muenchen.de   
Principal Investigator: Peter Müller, Prof.         
Sub-Investigator: Matthias Pietschmann, Dr.         
Sub-Investigator: Tobias Düll, Dr.         
Sub-Investigator: Joerg Hausdorf, Dr.         
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93042
Contact: Peter Angele, Prof.    +49 (0)9 41 94 46 803    peter.angele@klinik.uni-r.de   
Principal Investigator: Peter Angele, Prof.         
Sub-Investigator: Johannes Zellner, Dr.         
Sub-Investigator: Werner Krutsch, Dr.         
Sub-Investigator: Christian Pfeifer, Dr.         
Berufsgenossenschaftliche Unfallklinik Tübingen Withdrawn
Tübingen, Germany, 72076
Poland
Uniwersytecki Szpital Klniczny w Bialymstoku Active, not recruiting
Bialystok, Poland, 15276
Szpital sw. Lukasza BGL Sp z o.o. S.K.A. Recruiting
Bielsko Biala, Poland, 43309
Contact: Adrian Blasiak, MD    0048504946070    adrblasiak@gmail.com   
Contact: Anna Podlesny    0048512970570    aposlesny@lukasza.pl   
Principal Investigator: Adrian Blasiak, MD         
Samozdzielny Publiczny Zaklad Opieki Zdrowotnej Miejskiego Szpitala Zespolonego Recruiting
Czestochowa, Poland, 42200
Contact: Jacek Ociepka, MD    0048500073093    femur@wp.pl   
Contact: Przemyslaw Pala, MD    0048601525999    meniscus1@wp.pl   
Principal Investigator: Jacek Ociepka, MD         
Sub-Investigator: Przemyslaw Pala, MD         
Szpital Angelius Recruiting
Katowice, Poland, 40611
Contact: Ewa Gwiazda    +48515924387    e.gwiazda@angelius.org   
Contact: Barbara Wegrzyn    +48695651702    b.wegrzyn@angelius.org   
Principal Investigator: Arkadiusz Wiatr, MD         
Samozdzielny Publiczny Wojewodzki Szpital Chirurgii Urazowej Recruiting
Piekary Slaskie, Poland, 41940
Contact: Wojciech Widuchowski, MD    0048601822651    widuchw@mp.pl   
Contact: Robert Kokot, MD    0048507812581    kokot.robert@gmail.com   
Principal Investigator: Wojciech Widuchowski, MD         
Sub-Investigator: Robert Kokot, MD         
Lubuskie Centrum Ortopedii Withdrawn
Swiebodzin, Poland, 66200
Centrum Medycyny Sportowej Recruiting
Warszawa, Poland, 02034
Contact: Tomasz Swiatlowski, MD    0048601292700    tomasz.s@wp.pl   
Contact: Alina Lawicka    0048225929391    sekretariat@wp.pl   
Principal Investigator: Tomasz Swiatlowski, MD         
Switzerland
Universitätsklinikum Basel Recruiting
Basel, Switzerland, 4031
Contact: Geert Pagenstert, Dr.    +41 (0)6 12 65 25 25    gpagenstert@uhbs.ch   
Contact: Karin Wild    004161 3287716    karin.wild@usb.ch   
Principal Investigator: Geert Pagenstert, Dr.         
United Kingdom
The Royal Orthopaedic Hospital Active, not recruiting
Birmingham, United Kingdom, B31 2AP
University Hospital of Coventry and Warwickshire Not yet recruiting
Coventry, United Kingdom, CV22DX
Contact: Louise Clark    01788 663328    Louise.Clarkson@warwick.ac.uk   
Principal Investigator: Andrew Metcalfe, MD         
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: Peter Schranz, Dr.    +44 (0)139 240 3576      
Principal Investigator: Peter Schranz, Dr         
Sub-Investigator: Vipul Mandalia, Dr.         
Sponsors and Collaborators
Tetec AG
Investigators
Principal Investigator: Peter Angele, Prof. Universitätsklinikum Regensburg
  More Information

Responsible Party: Tetec AG
ClinicalTrials.gov Identifier: NCT01656902     History of Changes
Other Study ID Numbers: AAG-G-H-1202 
Study First Received: July 20, 2012
Last Updated: October 19, 2016
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Tetec AG:
Autologous Chondrocyte Transplantation
NOVOCART 3D plus
knee joint pain
safety
efficacy
treatment
TETEC
cartilage
ACT
cartilage repair
tissue
MOCART

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on December 08, 2016