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

NCT01640457 | Completed Phase 1 DMC

• 1 other identifier: AAG-G-H-1102
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Intervertebral Disc Displacement; Intervertebral Disc Degeneration

Keywords

degenerative disc; herniated disc; sequestrectomy; Autologous Disc Chondrocyte Transplantation; nucleotomy; safety; efficacy; treatment; lumbar spine; low back pain; adjacent degenerative disc; black disc; NOVOCART

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Index (ODI)

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

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) to 12-months follow-up

• Oswestry Disability Index (ODI)

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

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) to 24-months follow-up

• Oswestry Disability Index (ODI)

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

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) to 60-months follow-up

Secondary Outcomes (17)

• MRI-signal (disc height, disc volumetry, signal intensity)

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up

• Oswestry Disability Index

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up

• VAS for back pain and leg pain

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up

• Health-related quality of life as measured by the SF-36

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up

• Healthy Questionnaire EQ-5D

  Baseline assessment 1<45d pre-sequestrectomy, pre-transplantation (90 +/- 15d post-sequestrectomy) up to 60-months follow-up

Study Arms (3)

NDplus

EXPERIMENTAL

NOVOCART® Disc plus (Autologous Disc Chondrocyte Transplantation System)

Drug: NOVOCART® Disc plus

NDbasic

PLACEBO COMPARATOR

NOVOCART® Disc basic (media with no active cell component)

Device: NOVOCART® Disc basic

Sequestrectomy only (SC)

NO INTERVENTION

Sequestrectomy (standard of care)

Interventions

NOVOCART® Disc plus DRUG

Autologous Disc Chondrocyte Transplantation System (ADCT)

NDplus

NOVOCART® Disc basic DEVICE

ADCT (Media with no active cell component)

NDbasic

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient has a disc herniation with back and/or leg pain (radicular pain)
• The patient has an indication for sequestrectomy according to the guidelines of DGNC and DGOOC
• The patient is between 18-60 years of age.
• 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.
• 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.
• Patients must meet all of the following criteria to be considered for enrollment in the NOVO-CART® Disc study.
• The patient has a single-level lumbar disc herniation
• 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
• 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):
• \. The adjacent proximal disc has no degenerative signs according to Pfirrmann Score stage 3 to 5.
• Patients with adjacent degenerative disc (AAD):
• \. 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

You may not qualify if:

• The patient has had a previous surgery at the lumbar level(s) and has been treated with NOVOCART® Disc plus oder NOVOCART® Disc basic.
• The patient had a past recurrent disc herniation treated with sequestrectomy of the relevant disc.
• 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.
• BMI \> 35 kg/m2
• The patient has current or recent history of illicit drug, nicotine (more than 20 cigarettes per day) or alcohol abuse or dependence
• CRP \> 10mg/dl
• 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
• 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
• Immune defects or the affinity for infections of known or unknown causes
• 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).

Sponsors & Collaborators

• Tetec AG: lead

Study Sites (10)

University Hospital for Neurosurgery Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Charité Universitätsmedizin

Berlin, 13353, Germany

Location

DRK Kliniken Berlin Westend

Berlin, 14050, Germany

Location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Universitätsmedizin

Göttingen, 37075, Germany

Location

Hospital "BG-Kliniken Bergmannstrost"

Halle, 06112, Germany

Location

SHG Klinikum

Idar-Oberstein, 55743, Germany

Location

Städtisches Klinikum

Karlsruhe, 76133, Germany

Location

Berufsgenossenschaftliche Unfallklinik

Murnau am Staffelsee, 82418, Germany

Location

St. Franziskus Hospital

Münster, 48145, Germany

Location

Related Publications (1)

• Tschugg A, Michnacs F, Strowitzki M, Meisel HJ, Thome C. A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial. Trials. 2016 Feb 26;17(1):108. doi: 10.1186/s13063-016-1239-y.

  PMID: 26920137 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hans-Joerg Meisel, Professor

  Hospital "BG-Kliniken Bergmannstrost, Halle"

  PRINCIPAL INVESTIGATOR

• Claudius Thomé, Professor

  University Hospital for Neurosurgery Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: July 13, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2018
• Study Completion: June 14, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

AU (1); DE (9)