Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
NCT ID: NCT04186208
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
42 participants
OBSERVATIONAL
2017-04-25
2026-06-30
Brief Summary
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Detailed Description
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In this non-interventional study NOVOCART® 3D, which is marketed in Germany under Paragraph 4b Medicinal Products Act, will be used in routine clinical practice according to the authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® 3D may only be used by physicians who are trained on the product. The treatment with NOVOCART® 3D requires two surgeries. During the first surgery cartilage biopsies will be harvested arthroscopically and sent to TETEC AG (Tissue Engineering Technologies AG) for NOVOCART® 3D manufacturing, then NOVOCART® 3D will be transplanted during a second surgery about 3 to 4 weeks later.
All patients will be followed up for 5 years post NOVOCART® 3D transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.
NOVOCART® 3D post treatment rehabilitation should follow the recommendations given in the SmPC and during product training.
The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® 3D transplantation (primary analysis).
Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis).
The collected data will be documented using dedicated case report forms (CRFs) which are created and printed by TETEC AG.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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NOVOCART 3D
Autologous Chondrocyte Implantation
Eligibility Criteria
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Inclusion Criteria
* Medicinal indication for NOVOCART 3D treatment
Exclusion Criteria
13 Years
17 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Winicker Norimed GmbH
INDUSTRY
Tetec AG
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Angele, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Regensburg
Locations
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Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Mannheim, Baden-Wurttemberg, Germany
Sportklinik Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie
München, Bavaria, Germany
Klinikum rechts der Isar der technischen Universität München
München, Bavaria, Germany
Univerisätsklinikum Regensburg
Regensburg, Bavaria, Germany
Lubinus Clinicum Kiel
Kiel, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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AAG-O-H-1633
Identifier Type: -
Identifier Source: org_study_id
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