A Phase 2 interventional study of N-TEC and Platelet rich plasma in Patellofemoral Osteoarthritis, sponsored by University Hospital, Basel, Switzerland. Recruiting at 9 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University Hospital, Basel, Switzerland · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 41 studies in Osteoarthritis with a site in Switzerland — 4 open to participants now, 15 under way, none of them phase 3. Osteoarthritis · Switzerland.
Among the 41 studies in Osteoarthritis with a site in Switzerland, this one is the 14th largest by planned enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2024, is one of 3 in phase 2, reaches primary completion later than 9 of the 14 other live ones, and was the 36th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 437 are open to participants now.
Browse Osteoarthritis studies →4 of the 41 studies in Osteoarthritis with a site in Switzerland are open now. Recruiting first, the newest first:
University Hospital, Basel, Switzerland · Sites in Switzerland, Austria, Croatia and 5 more countries
Ages 18–70
University of Zurich · Sites in Switzerland
Ages 18+ · Healthy volunteers
Medacta International SA · Sites in Switzerland, Austria, Italy and 1 more country
Ages 18–75
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 286 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 1 · Phase 4 4
First in 2003; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 75 is close to the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Median enrollment 85 across the 24 interventional studies, 258 across the 16 observational. Of the 25 that completed or were terminated, 4 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 41 have an industry lead sponsor. The 10 most frequent:
University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
University Hospital, Basel, Switzerland has 6 studies filed under Osteoarthritis — fewer than ten, so there is no comparison to draw.
2 of the studies in Osteoarthritis with a site in Switzerland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT02038140Zimmer BiometZimmer Trabecular Metal Total Ankle PMCF | 2027-09 |
Add all 2 to your calendar (.ics) → With an account.
Among the 41 studies in Osteoarthritis with a site in Switzerland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N-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.
Biological: N-TEC
Total 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.
Biological: Platelet rich plasma
Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.
Also known as: Engineered cartilage graft
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.
Also known as: PRP
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)
Time frame: 24 months
Biovigilance
Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment.
Time frame: until 24 months
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)
Time frame: until 24 months
Iwano classification
Osteoarthritis grade determined based on X-rays according to Iwano classification (grades 1 to 4).
Time frame: until 24 months
Kellgren Lawrence classification
Osteoarthritis grade determined based on X-rays according to Kellgren Lawrence classification (grades 1 to 4).
Time frame: until 24 months
MOCART score
Magnetic Resonance Imaging (MRI) of Cartilage Repair Tissue (MOCART) score: radiological evaluation of repair tissue. Minimum score:0; maximum score: 100.
Time frame: until 24 months
Kujala self reported questionnaire
Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems)
Time frame: until 24 months
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.
Time frame: until 24 months
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).
Time frame: until 24 months
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).
Time frame: Unitl 24 months
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.
Time frame: until 24 months
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
Time frame: until 24 months
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.
Time frame: Until 24 months
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.
Time frame: Until 24 months
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.
Time frame: Until 24 months
Activity level
Patients will wear activity trackers for defined time periods to determine their activity level and assess if there is a correlation between the activity level and the clinical outcome.
Time frame: Until 24 months
Quality-adjusted life-years (QALY) outcome
Quality-adjusted life-years (QALY) is a measure of health outcome that combines the quantity and quality of life into a single value. It represents the value of an individual's health. QALY is used in cost-effectiveness analyses to compare the value of different healthcare interventions.
Time frame: Until 24 months
One Leg Hop test
The One Leg Hop test will be performed after patients had followed the physiotherapy program. This functional movement assessment is used to evaluate lower limb strength, power, and neuromuscular control. It involves hopping on one leg as far as possible and landing on the same leg while maintaining balance.
Time frame: Until 24 months
Y Balance test
The Y-Balance Test will be performed after patients had followed the physiotherapy program. It is a standardized test for assessing dynamic balance and movement quality, particularly in the lower extremities. It is used to assess injury risk and support post-injury rehabilitation.
Time frame: Until 24 months
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Sep 2028, 51 months after the start.
Of 82 phase 2 interventional studies under Osteoarthritis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland →