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NOVOCART® Inject Plus for Cartilage Defects of the Knee

NCT03319797 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-14

No results posted yet for this study

Summary

Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject plus in the Treatment of Cartilage Defects of the Knee. The primary objective of this trial is to demonstrate efficacy of NOVOCART® Inject plus for the treatment of cartilage defects of the knee based on the Knee injury and Osteoarthritis Outcome Score (KOOS) responder rate 24 month after transplantation.

Conditions

  • Cartilage Defects of the Knee

Interventions

DRUG

NOVOCART® Inject plus

Treatment with NOVOCART® Inject plus (Autologous chondrocyte implantation)

Sponsors & Collaborators

  • Tetec AG

    lead INDUSTRY

Principal Investigators

  • Philipp Niemeyer, MD · Orthopaedic Surgery Munich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2021-02-22
Completion
2024-02-22

Countries

  • Czechia
  • Germany
  • Hungary
  • Lithuania
  • Switzerland

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 NCT03319797 on ClinicalTrials.gov