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.
Highlights
Intervertebral disk degeneration (IVDD) is emphasized as an important cause of low back pain (LBP) [1]
Disk repair procedures are of interest to spine surgeons, because they offer a less invasive and biological alternative to lumbar fusion in an attempt to obviate LBP associated with IVDD earlier in the degenerative cascade
Twenty-four patients with single lumbar disk herniation were prospectively included in the study (Fig. 1)
Summary
Intervertebral disk degeneration (IVDD) is emphasized as an important cause of low back pain (LBP) [1]. Current treatment strategies are aggressive removal of the pathological disk or spondylodesis that do not address options of restoring structural or biological deteriorations of the intervertebral disk (IVD) as the underlying problem. Disk repair procedures are of interest to spine surgeons, because they offer a less invasive and biological alternative to lumbar fusion in an attempt to obviate LBP associated with IVDD earlier in the degenerative cascade. The IVD potentially be repaired after a herniation by transplanting the patient’s disk chondrocyte. According to this method, which is called the autologous disk-derived chondrocyte transplantation (ADCT), the disk tissue which herniated through the annulus fibrosus is removed at an initial surgical intervention. The chondrocytes are enzymatically isolated, expanded in vitro and the suspension is reinjected into the damaged IVD [11]
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