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Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine

NCT01640457 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-10-12

No results posted yet for this study

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.

Conditions

  • Intervertebral Disc Displacement
  • Intervertebral Disc Degeneration

Interventions

DRUG

NOVOCART® Disc plus

Autologous Disc Chondrocyte Transplantation System (ADCT)

DEVICE

NOVOCART® Disc basic

ADCT (Media with no active cell component)

Sponsors & Collaborators

  • Tetec AG

    lead INDUSTRY

Principal Investigators

  • Hans-Joerg Meisel, Professor · Hospital "BG-Kliniken Bergmannstrost, Halle"

  • Claudius Thomé, Professor · University Hospital for Neurosurgery Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2018-11-01
Completion
2021-06-14

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640457 on ClinicalTrials.gov