Status:
WITHDRAWN
Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
Lead Sponsor:
Tetec AG
Collaborating Sponsors:
Winicker Norimed GmbH
Conditions:
Cartilage Disease
Eligibility:
All Genders
Up to 17 years
Brief Summary
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee...
Detailed Description
In this non-interventional study NOVOCART® Inject, which is marketed in Germany under a license according to Section 4b of the AMG, will be used in routine clinical practice according to the current a...
Eligibility Criteria
Inclusion
- Pediatric patients (\< 18 years of age at implantation)
- Closure of the epiphysis adjacent to the biopsy harvest site or the defect to be treated confirmed by an adequate imaging modality
- Localized full-thickness cartilage defect (ICRS grade III or IV) of the knee
- Medicinal indication for NOVOCART® Inject treatment
Exclusion
- see NOVOCART Inject SmPC
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2032
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05391841
Start Date
May 1 2025
End Date
May 1 2032
Last Update
September 19 2025
Active Locations (6)
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1
St. Josefs-Hospital Cloppenburg gemeinnützige GmbH
Cloppenburg, Germany, 49661
2
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79119
3
OCM Klinik GmbH München
München, Germany, 81369
4
Klinikum rechts der Isar, Technische Universität München
München, Germany, 81675