Trial reportTrials2016
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.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01640457 (A Prospective Randomized Multicentre Phase I/II Clinical Trial to Evaluate Safety and Efficacy of NOVOCART® Disc Plus Autologous Disc Chondrocyte Transplantation), which is not on this map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
20 citing papers in PubMed, 29 citations in OpenAlex.
- Trial
- Intervertebral disc degeneration.Nature reviews. Disease primers · 2026Review
- Banked Primary Progenitor Cells for Allogeneic Intervertebral Disc (IVD) Therapy: Preclinical Qualification and Functional Optimization within a Cell Spheroid Formulation Process.Pharmaceutics · 2024Article
- Comprehensive narrative review on the analysis of outcomes from cell transplantation clinical trials for discogenic low back pain.North American Spine Society journal · 2023Article
- Intradiscal Injection of Autologous Discogenic Cells in Patients with Discectomy: A Prospective Clinical Study of Its Safety and Feasibility.Stem cells translational medicine · 2022Article
- Design and clinical application of injectable hydrogels for musculoskeletal therapy.Bioengineering & translational medicine · 2022Review
- Clinical Development of Regenerative Medicine Targeted for Intervertebral Disc Disease.Medicina (Kaunas, Lithuania) · 2022Review
- Cell sources proposed for nucleus pulposus regeneration.JOR spine · 2021Review
- Patient-specific apparent diffusion maps used to model nutrient availability in degenerated intervertebral discs.JOR spine · 2021Article
- Intervertebral Disc Regeneration Injection of a Cell-Loaded Collagen Hydrogel in a Sheep Model.International journal of molecular sciences · 2021Article
- Notochordal Cell-Based Treatment Strategies and Their Potential in Intervertebral Disc Regeneration.Frontiers in cell and developmental biology · 2021Review
- Intervertebral Disc Repair: Current Concepts.Global spine journal · 2020Article
- Expansion and characterization of cells from surgically removed intervertebral disc fragments in xenogen-free medium.Journal of biosciences · 2020Article
- Prognostic factors in the progression of intervertebral disc degeneration: Which patient should be targeted with regenerative therapies?JOR spine · 2019Review
- Article
- Cell therapy for intervertebral disc herniation and degenerative disc disease: clinical trials.International orthopaedics · 2019Review
- Calcium Microcrystal Formation in Recurrent Herniation Patients After Autologous Disc Cell Transplantation.Tissue engineering and regenerative medicine · 2017Article
- Effect of the adenovirus‑mediated Wip1 gene on lumbar intervertebral disc degeneration in a rabbit model.Molecular medicine reports · 2017Article
- Injectable nanofibrous spongy microspheres for NR4A1 plasmid DNA transfection to reverse fibrotic degeneration and support disc regeneration.Biomaterials · 2017Article
- Cell therapy for intervertebral disc repair: Clinical perspective.Journal of orthopaedic translation · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntervertebral disc degeneration is emphasized as an important cause of low back pain. Current surgical treatment provides relief to the accompanying pain and disability but does not restore the biological function of the intervertebral disc. NOVOCART™ Disc plus, an autologous cell compound for autologous disc chondrocyte transplantation, was developed to reduce the degenerative sequelae after lumbar disc surgery or to prophylactically avoid degeneration in adjacent discs. METHODS/
designThis is a multicenter, randomized, controlled, clinical phase I/II combination study. A total of 120 adult patients are allocated in a ratio of 2:1:1. Sample size and power calculations were performed to detect the minimal clinically important difference of 10 units, with an expected standard deviation of 12 in the Oswestry Disability Index, which is the primary outcome parameter. Secondary outcome parameters include the visual analog scale and the EQ-5D questionnaire. Changes in physical and mental health are evaluated using the Short Form-12 (SF-12). Moreover, radiological and functional outcomes are evaluated. The major inclusion criterion is a single lumbar disc herniation that requires sequestrectomy. Transplantation is performed 90 days thereafter. Study data generation (study sites) and data storage, processing, and statistical analysis are clearly separated. DISCUSSION: In this phase-I/II study, NDplus is being investigated for its clinical applicability, safety, and efficacy in the repair of herniated, nucleotomized discs, and of adjacent degenerated discs, if present. To date, autologous disc chondrocytes have not been transplanted into degenerative discs without previous disc herniation. As such, this is the first study to investigate a therapeutic as well as a prophylactic approach to treat degenerative discs of the lumbar spine.
trial registrationEudraCT No: 2010-023830-22, ID NCT01640457 , 8 November 2010.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.