Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
Status:
Completed
Trial end date:
2021-06-14
Target enrollment:
Participant gender:
Summary
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and
efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy,
and of the adjacent degenerated disc, if present. The objective of this clinical study is to
provide basis for a confirmatory study design (endpoints, methodologies) (Phase II), and to
develop a safety profile (Phase I). This study further aims at developing and validating
known and new biologic markers for the quality and clinical efficacy of the product as
requested in the context of identity, purity and potency characteristics of the
medicinal/investigational product.