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Patellofemoral OsteoarthritisPhase 2NCT06163573

Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

A Phase 2 study testing N-TEC and Platelet rich plasma in people with Patellofemoral Osteoarthritis, run by University Hospital, Basel, Switzerland at 9 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this investigator-initiated study is to assess the efficacy of treating patellofemoral osteoarthritis with an Advanced Therapy Medicinal Product (ATMP), autologous nasal chondrocyte tissue engineered cartilage (N-TEC), in comparison with a standard therapy using platelet rich plasma injections. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Patellofemoral Osteoarthritis
What is being tested?
N-TEC and Platelet rich plasma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
9 sitesin 3 countries
Study dates
6 Jun 2024to Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient age is ≥18 and ≤ 65 years at time of screening.
  • Symptomatic PFOA grade 1-3 according to Iwano Classification
  • Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
  • Baseline score of <60 on the KOOS Pain subjective knee evaluation.
  • Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion.
  • 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.
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  • Minimum values for women: Haemoglobin 110g/l, Platelets 150G/l, INR<1.3
  • Minimum values for men: Haemoglobin 120g/l, Platelets 150G/l, INR<1.3
  • Non-surgical standard of care options except for PRP have been exhausted.

Who cannot join

  • 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)
  • Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months).
  • Radiologically apparent degenerative joint disease of the tibiofemoral joint as determined by X-ray (Kellgren and Lawrence grade > 2) or MRI or pain in the tibiofemoral joint as assessed by clinical examination
  • Patient has excessive varus or valgus deformity (>5°)
Show all 26Show fewer
  • Patient had a patellar dislocation in the afflicted knee in the last 2 years.
  • Patient has a symptomatic meniscus lesion (or removal exceeding ½), as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI.
  • Patient has a body mass index (BMI) >35 kg/m2.
  • Patient has chronic rheumatoid arthritis, and/or infectious arthritis
  • Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee.
  • Patient has a known immunological suppressive disorder or is taking immunosuppressives.
  • Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
  • Instability of anterior, posterior collateral ligaments
  • The patient has a HIV/AIDS infection. (regulatory requirement)
  • The patient has an acute Treponema pallidum (syphilis) infection. (regulatory requirement)
  • The patient has an active hepatitis B or C infection assessed according to local laboratory standards using an antibody test and if positive, confirmatory test for active infection. Patients with a cured hepatitis B or C infection are not excluded. (regulatory requirement)
  • Patient is pregnant, breast feeding or anticipates becoming pregnant within 24 months after surgery.
  • Patient is currently participating or has participated in any other clinical study within 3 months prior to the screening visit.
  • Patient has known current or recent history of illicit drug or alcohol abuse or dependence defined as the continued use of alcohol or drugs despite the development of social, legal or health problems.
  • Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study.
  • Any known allergies, especially for porcine collagen, penicillin or streptomycin (manufacturing)
  • patients with increased anesthesiological and surgical risks (e.g. known or predicted difficult airway, myocardial infarction <60 days prior to surgery)
  • patients with increased bleeding risk (e.g. coagulopathies)
  • patients on anticoagulants whose anticoagulant therapy cannot be interrupted as appropriate to the given agent(s) and underlying condition
  • Patients with any active infections

Trial locations and contacts

9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Marcus Mumme, Dr contact

0041615565885

marcus.mumme@usb.ch

9 sites in 3 countries

Switzerland5 sites, 5 recruiting

  • University Hospital Basel

    Basel, 4031

    Florian Imhoff, PD Dr. med, + 41 613152760, Florian.Imhoff@usb.ch

    Recruiting

  • Crossklinik

    Basel, 4054

    Marcel Jakob, MD, 41 61 285 10 42, marcel.jakob@crossklinik.ch

    Recruiting

  • Hôpitaux universitaires de Genève

    Geneva, 1205

    Didier Hannouche, MD, 41 22 372 7802, Didier.Hannouche@hcuge.ch

    Recruiting

  • Ospedale Regionale di Lugano

    Lugano, 6962

    Marco Valoroso, MD, 41 91 811 71 58, Marco.Valoroso@eoc.ch

    Recruiting

  • Sportclinic, Klinik Hirslanden

    Zurich, 8032

    Marcus Mumme, MD, 41 44 527 47 50, mmumme@sportclinic.ch

    Mumme, MD, 41 44 387 29 77, mmumme@sportclinic.ch

    Recruiting

Other trials in Switzerland

Croatia2 sites, 2 recruiting

  • Poliklinika Ivković

    Zagreb, 10000

    Alan Ivkovic, Prof. Dr. med, +385 91 6127 349, alan.ivkovic@gmail.com

    Recruiting

  • Poliklinika Ortho Plus

    Zagreb, 10000

    Damir Hudetz, MD, +385 1 4404 248, ortohud@gmail.com

    Recruiting

Other trials in Croatia

Germany2 sites, 2 recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Tayfun Yilmaz, MD, +49 761 270 24010, tayfun.yilmaz@uniklinik-freiburg.de

    Not yet recruiting

  • Orthopädische Klinik König-Ludwig-Haus

    Würzburg, 97074

    Stephan Reppenhagen, MD, 49 931 803-3123, s-reppenhagen@uni-wuerzburg.de

    Not yet recruiting

Other trials in Germany

About this study

Official title: Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Engineered Cartilage Implantation in a Randomized, Controlled, Multi-center Phase II Clinical Trial

The purpose of this investigator-initiated study is to assess the efficacy of treating patellofemoral osteoarthritis with an Advanced Therapy Medicinal Product (ATMP), autologous nasal chondrocyte tissue engineered cartilage (N-TEC), in comparison with a standard therapy using platelet rich plasma injections.

The engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.

Read the detailed description

Knee osteoarthritis (OA) is one of the most common causes for pain and disability with over 260 million people affected worldwide. Recent studies found that knee OA often starts in the patello-femoral compartment of the knee (PFOA) and is diagnosed in ~39% of people with knee pain aged above 30 years. Thus, PFOA and progression to full OA plays a crucial role in the reduction of quality of life of many people and in the raise of healthcare costs.

The goal of this phase II trial is to (i) evaluate the efficacy of autologous Nasal Chondrocytes Tissue Engineered Cartilage (N-TEC) in comparison to an active comparator (Platelet Rich Plasma (PRP) injections) based on patients' self-assessed outcome scores (Knee Osteoarthritis Outcome Score (KOOS Pain), and to (ii) verify tissue regeneration as the postulated mode of action and thus the disease-modifying properties of the graft, as previously indicated in animal studies (x-ray, MRI). This proposed phase II trial will evaluate whether N-TEC improves the clinical efficacy, leading to an increase of at least 15 points higher in the main primary outcome (KOOS (pain) change at 24 months) than the comparator group. Secondary endpoints will include amongst others KOOS subscales (symptoms, pain, activity of daily living (ADL), sports, Quality of Life (QOL)), Kujala Anterior Knee Pain Scale, Western Ontario and McMaster Universities Osteoarthritis score (WOMAC), Marx Activity Rating Scale (MARS) and EQ-5d assessment at 6, 12 and 24 months compared to baseline and between groups. Further secondary endpoints will be the number of subjects non-responding to treatment (i.e., improvement in KOOS Pain below 13 units on a scale of 0-100) and treatment failures (deterioration of more than 13 points compared to baseline or switching to other regenerative treatments or joint replacement to evaluate efficacy). Adverse events will be recorded during the full course of the trial to assess safety. This will require enrolling a total of 75 patients in a multicenter, prospective study involving 9 clinical centers.

Being tested
N-TEC, Platelet rich plasma
Keywords
Nasal chondrocytes, Tissue engineering, Knee cartilage, Patellofemoral osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-TECBiological

    Also called Engineered cartilage graft

    Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.

  • Platelet rich plasmaBiological

    Also called PRP

    Injection of an autologous Conditioned Plasma ACP® on the basis of one injection per week for three consecutive weeks.

    Conditioned Plasma ACP®, Arthrex, one injection per week for three consecutive weeks.

Study groups in NCT06163573
Study groupRoleWhat they receive
N-TECExperimentalN-TEC is based on autologous nasal chondrocytes expanded and further cultured on type I/III collagen membranes for 2 weeks to allow cells to produce extracellular matrix containing cartilage specific proteins. The IMP is implanted in the knee at the patellofemoral joint.
Receives: Biological: N-TEC
Platelet Rich PlasmaActive comparatorTotal of 3 injections of about 5 ml each of platelet rich plasma (PRP), autologous Conditioned Plasma ACP®, Arthrex, one injection per week for three consecutive weeks.
Receives: Biological: Platelet rich plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain

    mean change in Knee Injury and Osteoarthritis Outcome Score for pain from baseline to 24 months between groups Minimum score: 0 Maximum score :100 (higher score means no knee problems)

    Measured: 24 months

Secondary outcomes (14)

  1. Biovigilance

    Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment.

    Measured: until 24 months

  2. Knee Injury and Osteoarthritis Outcome questionnaire

    patient self reported questionnaire for symptoms, activity of daily life, sports and quality of life Minimum score: 0 Maximum score: 100 (higher score means no knee problems)

    Measured: until 24 months

  3. Iwano classification

    Osteoarthritis grade determined based on X-rays according to Iwano classification (grades 1 to 4).

    Measured: until 24 months

  4. Kellgren Lawrence classification

    Osteoarthritis grade determined based on X-rays according to Kellgren Lawrence classification (grades 1 to 4).

    Measured: until 24 months

  5. MOCART score

    Magnetic Resonance Imaging (MRI) of Cartilage Repair Tissue (MOCART) score: radiological evaluation of repair tissue. Minimum score:0; maximum score: 100.

    Measured: until 24 months

  6. Kujala self reported questionnaire

    Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems)

    Measured: until 24 months

  7. EQ5d questionnaire

    patient self reported questionnaire including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    Measured: until 24 months

  8. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

    Self reported questionnaire to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.

    The instrument contains 24 items measuring 3 sub-scales: physical function (17 items), pain (5 items), and stiffness (2 items).

    Measured: until 24 months

  9. Visual Analogue Scale

    The VAS is used by patients to assess pain based on a numbered scale going from 0 (no pain) to 10 (maximal pain).

    Measured: Unitl 24 months

  10. Global Rating Of Change (GROC) likert scale

    Widely used score to assess whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change. Minimum score: -5 ; maximal score: +5.

    Measured: until 24 months

  11. Marx Activity Rating Scale (MARS) score

    This activity-related patient-reported outcome measure is widely used to assess the activity of a patient after treatment of the knee. It assesses how often the patient performs activities (running, cutting, deceleration and pivoting) in his healthiest and more active state. Minimum score: 0; maximum score: 16

    Measured: until 24 months

  12. Number of non responders

    Number of treated patients showing an improvement in KOOS Pain below 13 on a scale of 0 to 100 after 24 months compared to baseline.

    Measured: Until 24 months

  13. Number of treatment failures

    Treatment failures are treated patients who had to switch to an alternative surgical regenerative treatment or knee replacement. This clinical deterioration is defined as reduction in the KOOS score of > 13 after 24 months compared to baseline.

    Measured: Until 24 months

  14. MRI Osteoarthritis Knee Score (MOAKS)

    MRI Osteoarthritis Knee Score (MOAKS) is a semi quantitative score used to assess the severity and progression of osteoarthritis in the knee using magnetic resonance imaging (MRI). It evaluates various features like osteophytes, bone marrow lesions, and cartilage loss, providing a detailed picture of the disease's status.

    Measured: Until 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start6 Jun 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental group: biological: Autologous nasal chondrocytes and ECM proteins Control group: Platelet rich plasma injections
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06163573
Sponsor's protocol ID
2023-508640-21-00
Other IDs
2023
Status last verified
Sep 2026
First submitted
20 Nov 2023
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seitz S, Lehoczky G, Wixmerten A, Schuster-Amft C, Miot S, Shrestha K, Schaedelin S, Martin I, Mumme M. Treatment of patellofemoral osteoarthritis with nasal chondrocyte-based engineered cartilage implantation in a randomised, controlled, multicentre phase II clinical trial: protocol for a randomised controlled trial. BMJ Open. 2025 Aug 21;15(8):e106140. doi: 10.1136/bmjopen-2025-106140.

    PubMed 40840982

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-TEC and Platelet rich plasma in people with Patellofemoral Osteoarthritis, run by University Hospital, Basel, Switzerland at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Switzerland, Croatia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marcus Mumme, Dr (0041615565885, marcus.mumme@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06163573, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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