Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine (NDisc)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Tetec AG
Sponsor:
Information provided by (Responsible Party):
Tetec AG
ClinicalTrials.gov Identifier:
NCT01640457
First received: May 16, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if present. The objective of this clinical study is to provide basis for a confirmatory study design (endpoints, methodologies) (Phase II), and to develop a safety profile (Phase I). 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.


Condition Intervention Phase
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Drug: NOVOCART® Disc plus
Device: NOVOCART® Disc basic
Phase 1
Phase 2

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 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

Resource links provided by NLM:


Further study details as provided by Tetec AG:

Primary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) to 12-months follow-up ] [ Designated as safety issue: No ]

    Primary efficacy variable.

    Early evaluation for efficacy will be performed when all patients completed scheduled 12-months follow-up visit (Interim analysis).


  • Oswestry Disability Index (ODI) [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) to 24-months follow-up ] [ Designated as safety issue: No ]

    Primary efficacy variable.

    Primary evaluation for efficacy will be performed when all patients completed scheduled at 24-months follow-up visit (Interim analysis).


  • Oswestry Disability Index (ODI) [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) to 60-months follow-up ] [ Designated as safety issue: No ]

    Primary efficacy variable.

    Final analysis will be performed when all patients completed scheduled 60-months follow-up visit.



Secondary Outcome Measures:
  • MRI-signal (disc height, disc volumetry, signal intensity) [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Oswestry Disability Index [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • VAS for back pain and leg pain [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Health-related quality of life as measured by the SF-36 [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Healthy Questionnaire EQ-5D [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Neurological status [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Functional status [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Return to work (days) [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Analgesic Medication Use during the previous 14-day-time period [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up ] [ Designated as safety issue: No ]

    Secondary efficacy variable

    Early evaluation for efficacy will be performed at 12-months follow-up, primary evaluation for efficacy will be performed at 24-months follow-up, and final analysis will be performed at 60-months follow-up.


  • Physician assessments of ease of transplantation [ Time Frame: transplantation ] [ Designated as safety issue: No ]

    Outcome to quantify feasibility of procedure

    When all NDplus and NDbasic patients completed transplantation procedure.


  • Surgical parameters, including length of procedure [ Time Frame: Sequestrectomy and transplantation ] [ Designated as safety issue: No ]

    Outcome to quantify feasibility of procedure

    When all enrolled patients completed sequestrectomy and if applicable transplantation procedure.


  • Prevalence of subsequent surgical interventions [ Time Frame: 12-months post-operation ] [ Designated as safety issue: Yes ]

    Outcome to Quantify Safety

    A subsequent surgical intervention is defined as any invasive procedure performed at the index level to treat the same condition (herniation) or other conditions resulted from the transplantation/implantation procedure within the 12-month period post-operation.


  • Any unanticipated adverse event [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy up to 60-months follow-up at any scheduled and unscheduled visit ] [ Designated as safety issue: Yes ]
    Outcome to Quantify Safety

  • Specific laboratory parameters according to product compatibility and availability: CRP, IL-6, LTE4 [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 1,5-months follow-up ] [ Designated as safety issue: Yes ]

    Outcome to Quantify Safety (Phase I only)

    At sequestrectomy, 2h-, 6h-, 24h-, 36h- post surgery, transplantation, direct after transplantation, 6h-, 12h-, 18h-, 24h-, 30h-, 36h-, 42h-, 48h- post transplantation, 3 and 6 weeks post transplantation


  • Histology of the tissue explant [ Time Frame: Sequestrectomy ] [ Designated as safety issue: No ]
    Outcome to Develop and Validate Biological Markers

  • Gene expression by quantitative realtime PCR of expanded cells, and cell culture medium metabolites during expansion [ Time Frame: Transplantation ] [ Designated as safety issue: No ]
    Outcome to Develop and Validate Biological Markers

  • Biomarkers of blood and urine samples (SOX9, MMP-3, collagen type I, collagen type II, collagen type X, IL-1, aggrecan, BMP receptor Ia, BSP-2, FLT-1, collagen crosslinks, and yet to be defined additional elements) [ Time Frame: Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 24-months follow-up ] [ Designated as safety issue: No ]
    Outcome to Develop and Validate Biological Markers


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NDplus
NOVOCART® Disc plus (Autologous Disc Chondrocyte Transplantation System)
Drug: NOVOCART® Disc plus
Autologous Disc Chondrocyte Transplantation System (ADCT)
Placebo Comparator: NDbasic
NOVOCART® Disc basic (media with no active cell component)
Device: NOVOCART® Disc basic
ADCT (Media with no active cell component)
No Intervention: Sequestrectomy only (SC)
Sequestrectomy (standard of care)

Detailed Description:

This is a classical Phase II study with an implicated Phase I part. The Phase I/II combination study is a non-confirmatory study aimed at gathering preliminary clinical information on NOVOCART® Disc plus used in a new indication in the repair of a herniated disc. It will be conducted in a prospective, multicenter, unmasked, clinical trial including 120 subjects randomized to NOVOCART® Disc plus (NDplus, 60 subjects), media NOVOCART® Disc basic with no active cell component (NDbasic, 36 subjects) and to standard of care (SC) sequestrectomy as control (24 subjects). 24 patients will be enrolled in Phase I of the study (12 NDplus, 12 NDbasic) and 96 patients in Phase II (48 NDplus, 24 NDbasic, 24 SC).

All subjects will be evaluated at 1.5-, 3-, 6-, 12-, 24-, 36-, 48-months post-t0 examination in the SC study arm and 1.5-, 3-, 6-, 12-, 24-, 36-, 48-months post-t5 examination in the NDplus and NDbasic study arms, and then 5 years post-t0/t5 to collect long-term clinical data. Efficacy measurements for functional improvement will be evaluated among NDplus, NDbasic and SC. Physiological effects observed from MRI measurements will be compared between appropriate treatments depending on expected treatment mechanisms. Safety data of NDplus will be combined with NDbasic to contrast against SC on procedure related risks and NDplus against NDbasic and SC together on graft-related adverse experiences.

To optimize the usefulness of clinical information, data collected in the study may be analyzed and reviewed continuously. Early findings may be used to modify the study design when deemed appropriate and acceptable by the Sponsor's medical advisors. Data-driven adaptive actions include but are not limited to stopping enrollment early. The Sponsor will inform regulatory bodies, Ethic Committees, and investigators before implementing study design modifications.

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.

The study will follow each subject for a total of five years post-t0 examination in the SC study arm and post-t5 examination in the NDplus and NDbasic study arms to obtain long-term performance data.

Patients must have a single-level acute disc herniation with an indication for an elective sequestrectomy. They may further have corresponding disc degeneration in the proximal adjacent segment (Pfirrmann Score Stage 3-4). A total of 120 adults will be enrolled in this study.

Each patient will remain in the study for 5 years post t0/t5 examination to complete the planned follow-up phase. It is expected to take 6 years and five months to collect all required data for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 in-formed 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

Patients must meet all of the following criteria to be considered for enrollment in the NOVO-CART® Disc study.

  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 end plate sclerosis in the lumbar segment to be treated with NOVOCART® Disc plus oder NOVOCART® Disc basic

Patients without adjacent degenerative disc (HD):

4. The adjacent proximal disc has no degenerative signs according to Pfirrmann Score stage 3 to 5.

Patients with adjacent degenerative disc (AAD):

4. The patients has additional degenerative signs in the proximal adjacent lumbar level ac-cording to Pfirrmann 3-4, but no more than 25% disc height reduction

Exclusion Criteria:

  1. The patient has had a previous surgery at the lumbar level(s) and has been treated with NOVOCART® Disc plus oder NOVOCART® Disc basic.
  2. The patient had a past recurrent disc herniation treated with 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

    • surgical sterility
    • double barrier methods, e.g. condom or diaphragm in combination with spermicide
    • intrauterine contraceptive device
    • bilateral vasectomy of sexual partner at least 90 days prior to enrolment in combination with barrier methods (e.g. condom or diaphragm)
    • birth control pill
  8. The patient has a history of known allergies or a suspicion of allergies to any of the NO-VOCART® Disc plus oder 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 erythematosus, 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 oder 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, sagittal ) 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/sequestrectomy) Exclusion Criteria

1. Extensive damage of the Anulus, which subsequently poses a significantly greater risk of recurrence.

Exclusion criteria determined after tissue explant/sequestrectomy

  1. HIV infection
  2. Treponema pallidum (syphilis) infection
  3. active hepatitis B or C infection

Exclusion Criteria prior Transplantation/Implantation

1. Recurrent disc herniation after surgery and prior transplantation/implantation.

  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: NCT01640457

Contacts
Contact: Simone Steinert +49 7121 514 87 79 simone.steinert@tetec-ag.de

Locations
Austria
University Hospital for Neurosurgery Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Claudius Thomé, Professor    +43 (0) 512 504 27452    claudius.thome@uki.at   
Principal Investigator: Claudius Thomé, Professor         
Sub-Investigator: Anja Tschugg, MD         
Sub-Investigator: Sebastian Quirbach, MD         
Orthopaedic Hospital Vienna-Speising Not yet recruiting
Vienna, Austria, 1130
Contact: Michael Ogon, Professor    +43 (1) 80182 - 701    michael.ogon@oss.at   
Sub-Investigator: Claudia Eder, MD         
Germany
Charité Universitätsmedizin Not yet recruiting
Berlin, Germany, 13353
Contact: Peter Vajkoczy, Professor    +49 30 450 560 002    peter.vajkoczy@charite.de   
Contact: Marcus Czabanka, MD    +49 30 450 560 002    marcus.czabanka@charite.de   
Principal Investigator: Peter Vajkoczy, Professor         
Sub-Investigator: Marcus Czabanka, MD         
DRK Kliniken Berlin Westend Recruiting
Berlin, Germany, 14050
Contact: Olaf Suess, MD    +49 30 3035 4260    o.suess@drk-kliniken-berlin.de   
Contact: Sven Mularski, MD    +49 30 3035 4260    s.mularski@drk-kliniken-berlin.de   
Principal Investigator: Olaf Suess, MD         
Sub-Investigator: Sven Mularski, MD         
University Hospital Duesseldorf Not yet recruiting
Duesseldorf, Germany, 40225
Contact: Richard Bostelmann, MD    +49 (0) 176 54 53 13 11    Richard.Bostelmann@med.uni-duesseldorf.de   
Principal Investigator: Richard Bostelmann, MD         
Universitätsmedizin Not yet recruiting
Goettingen, Germany, 37075
Contact: Stefan Lakemeier, MD    +49 551 39 22788    stefan.lakemeier@med.uni-goettingen.de   
Contact: Sebastian Hoppe, MD    +49 551 39 22788    sebastian.hoppe@med.uni-goettingen.de   
Principal Investigator: Stefan Lakemeier, MD         
Sub-Investigator: Sebastian Hoppe, MD         
Hospital "BG-Kliniken Bergmannstrost" Recruiting
Halle, Germany, 06112
Contact: Hans-Jörg Meisel, Professor    +49 (0)345-1327404    meisel@bergmannstrost.com   
Principal Investigator: Hans-Jörg Meisel, Professor         
Sub-Investigator: Bodo-Christian Kern, MD         
Sub-Investigator: Peter Stosberg, MD         
Sub-Investigator: Lhagva Sanchin, MD         
SHG Klinikum Not yet recruiting
Idar-Oberstein, Germany, 55743
Contact: Jochen Tuettenberg, MD    +49 6781 66 1464    j.tuettenberg@io.shg-kliniken.de   
Principal Investigator: Jochen Tuettenberg, MD         
Städtisches Klinikum Recruiting
Karlsruhe, Germany, 76133
Contact: Uwe Spetzger, Professor    +49 721 974 3501    uwe.spetzger@klinikum-karlsruhe.de   
Contact: Gerd Winkler, MD    +49 721 974 3500    gerd.winkler@klinikum-karlsruhe.de   
Principal Investigator: Uwe Spetzger, Professor         
Sub-Investigator: Gerd Winkler, MD         
Universitätsklinikum Schleswig Holstein Not yet recruiting
Kiel, Germany, 24105
Contact: H. Maximilian Mehdorn, Professor    +49 431 597 4801    maximilian.mehdorn@uksh.de   
Contact: Senol Jadik, MD    +49 431 597 4801    senol.jadik@uksh.de   
Principal Investigator: H. Maximilian Mehdorn, Professor         
Sub-Investigator: Senol Jadik, MD         
St. Franziskus Hospital Recruiting
Muenster, Germany, 48145
Contact: Ulf Liljenqvist, Professor    +49 251 935 3693    ulf.liljenqvist@sfh-muenster.de   
Contact: Marc Schneider, MD    +49 251 935 3693    marc.schneider@sfh-muenster.de   
Principal Investigator: Ulf Liljenqvist, Professor         
Sub-Investigator: Marc Schneider, MD         
Berufsgenossenschaftliche Unfallklinik Recruiting
Murnau, Germany, 82418
Contact: Martin Strowitzki, MD    +49 8841482851    martin.strowitzki@bgu-murnau.de   
Contact: Michael Bierschneider, MD    +49 8841482853    michael.bierschneider@bgu-murnau.de   
Principal Investigator: Martin Strowitzki, PD Dr.         
Sub-Investigator: Michael Bierschneider, Dr.         
Sub-Investigator: Stephan Reidl         
Sponsors and Collaborators
Tetec AG
Investigators
Principal Investigator: Hans-Joerg Meisel, Professor Hospital "BG-Kliniken Bergmannstrost, Halle"
Principal Investigator: Claudius Thomé, Professor University Hospital for Neurosurgery Innsbruck
  More Information

No publications provided

Responsible Party: Tetec AG
ClinicalTrials.gov Identifier: NCT01640457     History of Changes
Other Study ID Numbers: AAG-G-H-1102
Study First Received: May 16, 2012
Last Updated: October 20, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Federal Office for Safety in Health Care

Keywords provided by Tetec AG:
degenerative disc
herniated disc
sequestrectomy
Autologous Disc Chondrocyte Transplantation
nucleotomy
safety
efficacy
treatment
lumbar spine
low back pain
adjacent degenerative disc
black disc
NOVOCART

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014