A Prospective Randomized Multicenter Phase I/II Clinical Trial to Evaluate Safety and Efficacy of NOVOCART Disk Plus Autologous Disk Chondrocyte Transplantation in the Treatment of Nucleotomized and Degenerative Lumbar Disks to Avoid Secondary...

Overview

Journal Neurosurg Rev

Specialty Neurosurgery

Date 2016 Aug 29

PMID 27567635

Citations 29

Authors

Anja Tschugg

Michael Diepers

Steinert Simone

Felix Michnacs

Sebastian Quirbach

Martin Strowitzki

Hans Jorg Meisel

Claudius Thome

Affiliations

Soon will be listed here.

Abstract

NOVOCART Disk plus, an autologous cell compound for autologous disk chondrocyte transplantation, was developed to reduce the degenerative sequel after lumbar disk surgery or to prophylactically avoid degeneration in adjacent disks, if present. The NDisc trial is an ongoing multi-center, randomized study with a sequential phase I study within the combined phase I/II trial with close monitoring of tolerability and safety. Twenty-four adult patients were randomized and treated with the investigational medicinal product NDisc plus or the carrier material only. Rates of adverse events in Phase I of this trial were comparable with those expected in the early time course after elective disk surgery. There was one reherniation 7 months after transplantation, which corresponds to an expected reherniation rate. Immunological markers like CRP and IL-6 were not significantly elevated and there were no imaging abnormalities. No indications of harmful material extrusion or immunological consequences due to the investigational medicinal product NDplus were observed. Therefore, the study appears to be safe and feasible. Safety analyses of Phase I of this trial indicate a relatively low risk considering the benefits that patients with debilitating degenerative disk disease may gain.

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