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. MedDRA version: 20.0 Level: LLT Classification code 10022634 Term: Intervertebral disc disorders System Organ Class: 100000004859
Conditions
Interventions
Product Name: NOVOCART® Disc plus
Pharmaceutical Form: Injection
INN or Proposed INN: Disc Chondrocytes
Concentration unit: ml millilitre(s)
Concentration type: range
Concentration number: 0.9-1.1
Pha
Sponsors
TETEC AG
Eligibility
Sex/Gender
All
Inclusion 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 (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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 determine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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.;Secondary Objective: • 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. ;Primary 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) ;Timepoint(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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 ;Timepoint(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. | — |
Countries
Austria, Germany
Contacts
Public ContactSimone Steinert, Study Manager
TETEC AG
Outcome results
None listed