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NCT02348697: NISANIK
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
trial testing NOVOCART 3D in Cartilage Diseases in 81 participants. Completed in 30 October 2019.
30 October 2019
Quick facts
| Lead sponsor | Tetec AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 81 |
| Start date | 1 June 2015 |
| Primary completion | 30 October 2019 |
| Estimated completion | 30 October 2019 |
| Sites | 9 locations across Germany |
Drugs / interventions tested
- NOVOCART 3D — full drug profile →
Conditions studied
- Cartilage Diseases — all drugs for Cartilage Diseases →
Sponsor
Tetec AG — full company profile →
Who can join
Adults 14 to 50, any sex, with Cartilage Diseases. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
Time frame: 36 month
Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
Sponsor's own description
Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Cell-based tissue engineering strategies used in the clinical repair of articular cartilage.
Huang BJ, Hu JC, Athanasiou KA. · · 2016 · cited 274× · PMID 27177218 · DOI 10.1016/j.biomaterials.2016.04.018 -
Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.
Kim J, Park J, Song SY, Kim E. · · 2022 · cited 14× · PMID 35582708 · DOI 10.1016/j.reth.2022.04.004 -
A non-interventional study to evaluate the safety and effectiveness of a biphasic, chondrocyte-containing biomaterial (NOVOCART® 3D) in the treatment of localized full-thickness cartilage defects or osteochondral lesions of the knee joint (NISANIK).
Lenz JE, Weber J, Zellner J, Zimmermann G, et al · · 2025 · cited 1× · PMID 40809995 · DOI 10.1002/jeo2.70346
Verify or expand the search:
- PubMed search for NCT02348697
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Tetec AG trials
Trials by the same sponsor.
- NCT03808623 — Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MAC · completed
- NCT03319797 — NOVOCART® Inject Plus for Cartilage Defects of the Knee · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02348697 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tetec AG
- Last refreshed: 2 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02348697.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing