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DRKS00010673
Alternativer Eintrag mit zusätzlichen lokalen Informationen: NCT02673905

Randomized, Multi-center Phase II Clinical Trial for the Regeneration of Cartilage Lesions in the Knee Using Nasal Chondrocyte-based Tissue (N-TEC) or Nasal Chondrocyte-based Cell (N-CAM)-Therapies

Datenbasis: WHO (Import vom 20.06.2024)
Geändert: 13.01.2023, 08:53
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Tear; Knee, Cartilage, Articular

Interventions (Datenquelle: WHO)

Intervention 1: Other: Tissue Engineered Product

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria: - Patient is =18 and =65 years old at time of screening.

- Patient has a localized articular cartilage defect of the femoral condyle and/or
the trochlea of the knee. 2 localized cartilage defects are accepted if the
total defect size is = 8 cm2, both cartilage defects are located at the femoral
condyle and/or the trochlea and both cartilage defects are to be treated with
N-CAM or N-TEC.

- Patient has a defect of grade 3 or 4 according to the ICRS classification.

- Patient has a defect size =2 and =8 cm2 as assessed by MRI/arthroscopy.

- Patient has an intact (=ICRS Grade 1 ) articulating joint surface (no kissing
lesions).

- Patient has an intact meniscus (maximum 1/3-resection).

- Patient has a stable knee joint or sufficiently reconstructed ligaments. If not,
ligament repair has to be done during the operation or within 6 weeks of the
planned cartilage treatment.

- Patient has a maximum baseline score of 75/100 in the KOOS subjective knee
evaluation.

- Patient is willing and able to give written informed consent to participate in
the study and to comply with all study requirements, including attending all
follow-up visits and assessments and to complete postoperative rehabilitation
regimen.
Exclusion criteria: - Patient is the investigator or any sub-investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct
of the protocol or in a dependency or employment with the sponsor.

- Patient is unable to understand the patient information

- Patient is unable to undergo magnetic resonance imaging (MRI) or is sensitive to
gadolinium

- Patient has had prior surgical treatment of the target knee within 12 months using
mosaicplasty and/or microfracture (Note: prior diagnostic arthroscopy with
debridement and lavage are acceptable within 12 months). Anterior cruciate ligament
repair is accepted, if the target knee is stable or a primary ACL reconstruction is
performed within 6 weeks of the planned cartilage treatment.

- Patient has an onset of symptoms of > 5 years.

- Patient has a relevant meniscus tear. Partial meniscal removal allowed, if not
exceeding 1/3. Meniscus suture is not allowed in parallel, but if successful,
cartilage treatment might be added 12 months later.

- Patient has radiologically apparent degenerative joint disease in the target knee as
determined by Kellgren and Lawrence grade >2.

- Patient has chronic inflammatory arthritis, and/or infectious arthritis.

- Patient has an unstable knee joint or insufficiently reconstructed ligaments. If
ligament repair is necessary, the repair has to be performed during the operation or
within 6 weeks of the planned cartilage treatment.

- Patient has malalignment (no valgus- or varus-deformity) in the target knee = 5°. In
suspected cases, the mechanical axis must be established radiographically through
complete leg imaging during standing and in a.p. or rather p.a. projection. If
alignment surgery is necessary, surgery has to be performed within 6 weeks of the
planned cartilage treatment.

- Patient has an osteochondral defect (defined as bony substance defect of >3mm depth).
Bone marrow edema is allowed.

- Patient has relevant bilateral lower limb pain.

- Patient has a known systemic connective tissue disease.

- Patient has a known autoimmune disease.

- Patient has a known immunological suppressive disorder or is taking
immunosuppressives.

- Patient is currently systemically or intra-articularly taking steroids and/or has
used steroids within the 30 days prior to the planned treatment.

- The patient has a known history of HIV/AIDS. (Protection of staff)

- The patient has a known history of Treponema pallidum (syphilis). (Protection of
staff)

- The patient has an active hepatitis B or C infection with verified antigens. Patients
with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
(Protection of staff)

- The patient has at the site of surgery an active systemic or local microbial
infection, eczematization or inflammable skin alterations (including Protozoonosis:
Babesiosis, Trypanosomiasis (e.g. Chagas-Disease), Leishmaniasis, persistent
bacterial infections

Weitere Angaben zur Studie im WHO-Primärregister

http://www.drks.de/DRKS00010673

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00010673
Weitere Informationen zur Studie

Datum der Studienregistrierung

20.06.2016

Einschluss der ersten teilnehmenden Person

31.08.2016

Rekrutierungsstatus

Pending

Wissenschaftlicher Titel (Datenquelle: WHO)

Randomized, Multi-center Phase II Clinical Trial for the Regeneration of Cartilage Lesions in the Knee Using Nasal Chondrocyte-based Tissue (N-TEC) or Nasal Chondrocyte-based Cell (N-CAM)-Therapies - NosetoKnee2

Studientyp (Datenquelle: WHO)

interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: . Assignment: Parallel. Study design purpose: Treatment

Phase (Datenquelle: WHO)

II

Primäre Endpunkte (Datenquelle: WHO)

- comparison of the efficacy of the two investigational medicinal products (IMPs); time frame: 24 months; Assessment whether a tissue therapy 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

Sekundäre Endpunkte (Datenquelle: WHO)

- stability and Integration of the implanted IMP; time frame: 24 months; Assessment of the stability and Integration of the graft with the adjacent tissues by MOCART Score (magnetic resonance observation of cartilage repair tissue) derived from the MRI as well as the remodeling of the implanted grafts towards native cartilage assessed by dGEMRIC evaluation (MRI) from the 24-month follow-up
- efficacy for patient; Improvement of the KOOS-Score from baseline to 24 months

Kontakt für Auskünfte (Datenquelle: WHO)

Bitte wenden Sie sich an den Sponsor / Please refer to primary sponso

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Croatia, Germany, Italy, Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Marcel Jakob, Prof. Dr.
+41 61 328 72 40
marcel.jakob@usb.ch

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Marcel Jakob, Prof. Dr.
Univeristy Hospital Basel

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

Alternativer Eintrag mit zusätzlichen lokalen Informationen: NCT02673905
NosetoKnee2
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