EUCTR2010-023830-22-DE进行中（未招募）1 期
Disc 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 - NDisc Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TETEC AG
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
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