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 secondarReportar como inadecuado




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 secondar - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 17:108

First Online: 26 February 2016Received: 02 May 2015Accepted: 17 February 2016DOI: 10.1186-s13063-016-1239-y

Cite this article as: Tschugg, A., Michnacs, F., Strowitzki, M. et al. Trials 2016 17: 108. doi:10.1186-s13063-016-1239-y

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.

DiscussionIn 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

KeywordsAutologous disc chondrocyte transplantation Degenerative disc disease Lumbar back pain Sequestrectomy AbbreviationsADCTautologous disc chondrocyte transplantation

ADDadjacent disc degeneration

BTPEGbis thio-polyethylene glycol

CROclinical research organizations

CRPC-reactive protein

EQ-5DEuroQuality of Life-5 Dimension

FASFull Analysis Set

GCPGood Clinical Practice

ILInterleukine

IVDDintervertebral disc degeneration

LBPlow back pain

MedDRA™Medical Dictionary for Regulatory Activities

MRImagnetic resonance imaging

NDplusNOVOCART™ Disc plus

SF-12Short Form-12

ODIOswestry Disability Index

TEAEtreatment emergent adverse events

VASVisual Analog Scale

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Autor: Anja Tschugg - Felix Michnacs - Martin Strowitzki - Hans Jörg Meisel - Claudius Thomé

Fuente: https://link.springer.com/







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