title: 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 disease: safety results of Phase I-a short report.
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.
authors: Department of Neurosurgery, Medical University of Innsbruck, Anichstr. 35, A-6020, Innsbruck, Austria. anja.tschugg@i-med.ac.at.
authors: Anja
authors: A
authors: Tschugg
authors: Department of Neuroradiology, Cantonal Hospital Aarau, Aarau, Switzerland.
authors: Michael
authors: M
authors: Diepers
authors: TETEC Tissue Engineering Technologies AG, Reutlingen, Germany.
authors: Steinert
authors: S
authors: Simone
authors: TETEC Tissue Engineering Technologies AG, Reutlingen, Germany.
authors: Felix
authors: F
authors: Michnacs
authors: Department of Neurosurgery, Medical University of Innsbruck, Anichstr. 35, A-6020, Innsbruck, Austria.
authors: Sebastian
authors: S
authors: Quirbach
authors: Neurocenter, Trauma Center Murnau, Murnau, Germany.
authors: Martin
authors: M
authors: Strowitzki
authors: Department of Neurosurgery, BG-Clinic Bergmannstrost, Halle, Germany.
authors: Hans Jörg
authors: HJ
authors: Meisel
authors: Department of Neurosurgery, Medical University of Innsbruck, Anichstr. 35, A-6020, Innsbruck, Austria.
authors: Claudius
authors: C
authors: Thomé
mesh_terms: D000293:Adolescent; D000328:Adult; D019902:Chondrocytes / Q000637:transplantation*; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000628:therapy*; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D008161:Lumbosacral Region / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014182:Transplantation, Autologous / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
keywords: Autologous disk chondrocyte transplantation; Degenerative disk disease; Lumbar back pain; Sequestrectomy