Registrationsdatum der Studie
Einschluss der ersten teilnehmenden Person
Authorised-recruitment may be ongoing or finished
Randomized, multi-center phase II clinical trial for the regeneration of cartilage lesions in the knee using nasal chondrocyte-based tissue (NTEC) or nasal chondrocyte-based cell (N-CAM)-therapies - Nose to Knee II
Interventional clinical trial of medicinal product
Design der Studie
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other trial design description: two treatment arms (N-TEC and N-CAM)
If controlled, specify comparator, Other Medicinial Product: no
Number of treatment arms in the trial: 2
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Main Objective: This proposed phase II trial seeks to primarily define whether a tissue
therapy for cartilage repair in the knee will improve the clinical efficacy
for the patient, leading to an increase of at least 10 points in the main
primary outcome (self-assessed score KOOS) after 24 months as
compared to the cell therapy group. Comparison between groups will
allow assessment of whether the tissue therapy is superior to the cell
The KOOS score will be used to measure the primary outcome. The
primary endpoint is the difference in the KOOS at 24 months between
the two techniques (comparison of the efficacy of the technique). The
KOOS score, covering the fields of Symptoms, Pain, Activities of daily
life, Sport activities and Quality of life, is suitable for assessing the
improvement for the patient. This validated questionnaire is widely
used to assess efficacy of cartilage repair therapies.;Secondary Objective: The stability and integration as well as the morphological properties of
the graft will be assessed by the MOCART Score.
The remodeling of the tissue after implantation towards native
cartilage will be assessed by dGEMRIC evaluation (MRI) from the 24-
month assessment of the relative ?R1.
The KOOS will be recorded for patients at baseline visit 1 or 2 and at
the 12- and 24-month follow-up assessments. Variations over time will
be recorded through completion of the questionnaires at enrolment and
at each follow-up visit (12 and 24 months after treatment).
Retrospectively data will be analyzed to identify the possibility of
treatment selection (tissue therapy vs. cell therapy) in relation to the
time after onset of symptoms (acute vs chronic cartilage lesions) in
order to determine if one treatment is more beneficial than the other
(e.g. higher stability, better integration etc.).
The study will evaluate the safety by the number of SADRs or SUSARs.;Primary end point(s): KOOS score: The primary endpoint is the KOOS subjective score at the
24-month visit. The difference in the KOOS-score will be compared
between the two groups (Comparison of Efficacy of Treatment);Timepoint(s) of evaluation of this end point: after 24 months
Secondary end point(s): MOCART Score (MRI): The MRI will be performed at 3, 12, 24 months
follow-up visits and MOCART scores calculated. (Assessment of
stability and integration)
• dGEMRIC evaluation (MRI): The relative delta R1 will be evaluated
by dGEMRIC and recorded at 3, 12, 24 months follow-up visits and
referenced to the native cartilage of the treated knee. (Assessment of
quality of the repair tissue)
• A further questionnaire (EQ-5d) at 12 and 24 month and an
additional time point (12 month) for KOOS will allow the more detailed
analysis of the clinical development of the patient's recovery and
elucidate changes in the perceived quality of life before and after
• Retrospective analysis of primary and secondary endpoint data with
regard to the onset of symptoms to identify a possible selection of
treatment of acute (onset < 1 years) or chronic (onset >1 years)
• Any AE and SAEs will be recorded regarding event descriptions,
onset, resolution dates and relationship to the IMP. All SADR or SUSAR
will be reported to Basel as leading center and the respective
authorities.;Timepoint(s) of evaluation of this end point: MRI and dGEMRIC will be performed at 3, 12, 24 months follow-up.
questionnaires will be performed after 12 and 24 months follow-up.
Retrospective Analysis will be performed at the end of the study.
AEs will be recorded throughout the study.
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EU Horizon 2020