Patellofemoral OsteoarthritisPhase 2ENCANTONCT06576583
Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.
A Phase 2 study testing Engineered cartilage graft (N-TEC), Autologous Matrix Induced Chondrogenesis (AMIC) and Patellofemoral Arthroplasty (PFA) in people with Patellofemoral Osteoarthritis, run by University Hospital, Basel, Switzerland at 11 sites in 8 countries.
Trial summary
ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patellofemoral Osteoarthritis
- What is being tested?
- Engineered cartilage graft (N-TEC), Autologous Matrix Induced Chondrogenesis (AMIC) and Patellofemoral Arthroplasty (PFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 15 Jul 2025to Jan 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is ≥18 and ≤ 70 years at time of screening.
- Symptomatic PFOA grade 1-4 according to Iwano Classification
- Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
- Baseline score of <75 on the KOOS-5 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 120g/l, Platelets 150G/l, INR<1.3
- Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR<1.3
- Patients have failed to demonstrate adequate response to non-pharmacological interventions (e.g. structured land-based exercise programs) and pharmacological first-line treatment such as topical NSAIDs
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 unwilling, unable or lacking the capacity to provide informed consent
- 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°), unless corrected during implantation
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- 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 systemic immunosuppressives.
- Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
- Instability of anterior, posterior and/or 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 with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies 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.
- Known allergies for porcine collagen (scaffold), penicillin or streptomycin (manufacturing)
- Nail-patella syndrome
- Patients who will likely benefit from conservative therapy, such as physiotherapy, medical training therapy and pain medication
- 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
11 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 8 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
Evangelisches Waldkrankenhaus Spandau
Berlin, 13589
Ulrich Nöth, MD, +49 30 3702 1002, ulrich.noeth@jsd.de
- Recruiting
Orthopedic Clinic König-Ludwig-Haus
Würzburg, 97074
Stephan Reppenhagen, MD, +49 931-803-3123, s-reppenhagen.klh@uni-wuerzburg.de
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, 20157
Giuseppe Peretti, MD, +39 0283506790, giuseppe.peretti@unimi.it
- Not yet recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, 00128
Gianluca Vadalà, MD, + 39 6225411123, G.Vadala@policlinicocampus.it;
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Gyözö Lehoczky, MD, +41 61 704 2615, Gyözö.Lehoczky@ukbb.ch
Florian Imhoff, MD, + 41 61 315 2760, knie-team@usb.ch
- Recruiting
Crossklinik
Basel, 4054
Marcel Jakob, MD, +41 61 285 10 42, marcel.jakob@crossklinik.ch
Austria1 site, 1 recruiting
- Recruiting
Orthopedic Hospital Vienna-Speising
Vienna, 1130
Christian Albrecht, MD, + 43 (1) 801 82 - 1181, christian.albrecht@oss.at
Croatia1 site, 1 recruiting
- Not yet recruiting
University Hospital Sveti Duh
Zagreb, 10000
Alan Ivkovic, MD, +38513712320, alan.ivkovic@gmail.com
Netherlands1 site, 1 recruiting
- Not yet recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Pieter Emans, MD, +31-43-2875039, p.emans@mumc.nl
Poland1 site, 1 recruiting
- Recruiting
Zeromski hospital
Krakow, 31-913
Pawel Skowronek, MD, + 48 12 622 96 24, pawelskowronek@interia.pl
Sweden1 site, 1 recruiting
- Recruiting
Department of Orthopaedics, University of Gothenburg (UGOT)
Mölndal, 80
Ola Rolfson, MD, 031-3430852, ola.rolfson@vgregion.se
About this study
Official title: Randomized, Controlled, Multi-center Phase II Clinical Trial for the Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Tissue Engineered Cartilage Implantation vs Current Standard of Care
ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA.
The N-TEC 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 multi-center phase II trial is to (i) evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA based on patient self-assessed questionnaires (Knee Injury and Osteoarthritis Outcome Score, KOOS) and (ii) verify the postulated mode of action, which is expected to be of regenerative nature and will be assessed by evaluation of disease-modification by x- ray and structural regeneration of the osteoarthritic joint destruction by MRI analysis. A total of 150 patients with early stage of PFOA (Iwano grade 1-2; 75 patients) or late stage of PFOA (Iwano grade 3-4; 75 patients) will be enrolled in 11 clinical centers and randomized to either N-TEC implantation or active comparator (AMIC or PFA).
- Conditions
- Patellofemoral Osteoarthritis
- Being tested
- Engineered cartilage graft (N-TEC), Autologous Matrix Induced Chondrogenesis (AMIC), Patellofemoral Arthroplasty (PFA)
- Keywords
- Nasal chondrocytes, Tissue engineering, Knee cartilage, Patellofemoral osteoarthritis, Autologous Matrix Induced Chondrogenesis (AMIC), Patellofemoral arthroplasty (PFA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engineered cartilage graft (N-TEC)Biological
Nasal chondrocytes based tissue engineered cartilage
Autologous Matrix Induced Chondrogenesis (AMIC)Procedure or surgery
Autologous Matrix Induced Chondrogenesis is performed through bone drilling and covering with Chondro-Gide® to attract bone marrow stem cells
Patellofemoral Arthroplasty (PFA)Procedure or surgery
Surgical implantation of a medical device, Zimmer Gender Solutions Patellofemoral Joint Prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Engineered cartilage graft (N-TEC)-Iwano grade 1-2 | Experimental | 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. Receives: Biological: Engineered cartilage graft (N-TEC) |
| Autologous Matrix Induced Chondrogenesis-Iwano grade 1-2 | Active comparator | AMIC® Chondro-Gide® combines microfracturing (MFx) with the use of Chondro-Gide®, which covers and protects both the super clot resulting from MFx and the repair tissue. Receives: Procedure: Autologous Matrix Induced Chondrogenesis (AMIC) |
| Engineered cartilage graft (N-TEC)-Iwano grade 3-4 | Experimental | 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. Receives: Biological: Engineered cartilage graft (N-TEC) |
| Patellofemoral Arthroplasty (PFA)-Iwano grade 3-4 | Active comparator | Patellofemoral Joint Prosthesis Receives: Procedure: Patellofemoral Arthroplasty (PFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)-5
Difference in 2-year change (baseline to 24 month follow-up) in the KOOS -5 score between patients undergoing N-TEC tissue implantation and patients receiving AMIC or PFA. Minimum score: 0 Maximum score: 100 (higher score means no knee problems)
Measured: 24 months
Secondary outcomes (11)
Knee Injury and Osteoarthritis Outcome questionnaire
patient self reported questionnaire for pain
Measured: 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)
Measured: Until 24 months
Kujala questionnaire
patient self reported questionnaire for Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems)
Measured: 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). Minimum score: 0 (no knee problems) Maximum score: 96 (worst knee problems)
Measured: Until 24 months
EQ-5D-5L questionnaire
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Until 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.
Measured: 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 treatments 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
Morphological analysis
Morphological analysis with assessment of whole cartilage volume (in mm3) by radiological assessment (MRI)
Measured: Until 24 months
Collagen network organization
Collagen network organization with T2 mapping and RADIOMICS GLCM by radiological assessment (MRI)
Measured: Until 24 months
Osteoarthritis grading
Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification by radiological assessment (X-ray)
Measured: Until 24 months
Biovigilance
Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment.
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.
- First posted28 Aug 2024
- Study start15 Jul 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland, Wuerzburg University Hospital, Medical University of Vienna, Videoreha, University of Oulu, Theracell Laboratories, Promove-Biotec GmbH, Maastricht University, Foundation National Reumafonds, Angry@Arthritis, University of Miami, Geistlich Pharma AG, European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576583
- Sponsor's protocol ID
- 2024-513683-25-00
- Acronym
- ENCANTO
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multi-center Phase II Clinical Trial for the Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Tissue Engineered Cartilage Implantation vs Current Standard of Care
- ClinicalTrials.gov ID
- NCT06576583
- Acronym / sponsor ID
- ENCANTO / 2024-513683-25-00
- Conditions
- Patellofemoral Osteoarthritis
- Keywords
- Nasal chondrocytes, Tissue engineering, Knee cartilage, Patellofemoral osteoarthritis, Autologous Matrix Induced Chondrogenesis (AMIC), Patellofemoral arthroplasty (PFA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland, Wuerzburg University Hospital, Medical University of Vienna, Videoreha, University of Oulu, Theracell Laboratories, Promove-Biotec GmbH, Maastricht University, Foundation National Reumafonds, Angry@Arthritis, University of Miami, Geistlich Pharma AG, European Union
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA.
The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.
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 multi-center phase II trial is to (i) evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA based on patient self-assessed questionnaires (Knee Injury and Osteoarthritis Outcome Score, KOOS) and (ii) verify the postulated mode of action, which is expected to be of regenerative nature and will be assessed by evaluation of disease-modification by x- ray and structural regeneration of the osteoarthritic joint destruction by MRI analysis. A total of 150 patients with early stage of PFOA (Iwano grade 1-2; 75 patients) or late stage of PFOA (Iwano grade 3-4; 75 patients) will be enrolled in 11 clinical centers and randomized to either N-TEC implantation or active comparator (AMIC or PFA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Engineered cartilage graft (N-TEC)-Iwano grade 1-2 | Experimental | Biological: Engineered cartilage graft (N-TEC)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. |
| Autologous Matrix Induced Chondrogenesis-Iwano grade 1-2 | Active comparator | Procedure: Autologous Matrix Induced Chondrogenesis (AMIC)AMIC® Chondro-Gide® combines microfracturing (MFx) with the use of Chondro-Gide®, which covers and protects both the super clot resulting from MFx and the repair tissue. |
| Engineered cartilage graft (N-TEC)-Iwano grade 3-4 | Experimental | Biological: Engineered cartilage graft (N-TEC)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. |
| Patellofemoral Arthroplasty (PFA)-Iwano grade 3-4 | Active comparator | Procedure: Patellofemoral Arthroplasty (PFA)Patellofemoral Joint Prosthesis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient age is ≥18 and ≤ 70 years at time of screening.
- Symptomatic PFOA grade 1-4 according to Iwano Classification
- Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
- Baseline score of <75 on the KOOS-5 subjective knee evaluation.
- Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion.
Key exclusion criteria (27 listed)
- 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 unwilling, unable or lacking the capacity to provide informed consent
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engineered cartilage graft (N-TEC)Nasal chondrocytes based tissue engineered cartilage | Biological | Engineered cartilage graft (N-TEC)-Iwano grade 1-2, Engineered cartilage graft (N-TEC)-Iwano grade 3-4 |
| Autologous Matrix Induced Chondrogenesis (AMIC)Autologous Matrix Induced Chondrogenesis is performed through bone drilling and covering with Chondro-Gide® to attract bone marrow stem cells | Procedure or surgery | Autologous Matrix Induced Chondrogenesis-Iwano grade 1-2 |
| Patellofemoral Arthroplasty (PFA)Surgical implantation of a medical device, Zimmer Gender Solutions Patellofemoral Joint Prosthesis. | Procedure or surgery | Patellofemoral Arthroplasty (PFA)-Iwano grade 3-4 |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)-5
Time frame: 24 months
Difference in 2-year change (baseline to 24 month follow-up) in the KOOS -5 score between patients undergoing N-TEC tissue implantation and patients receiving AMIC or PFA. Minimum score: 0 Maximum score: 100 (higher score means no knee problems)
11 secondary outcomes
Knee Injury and Osteoarthritis Outcome questionnaire
Time frame: until 24 months
Knee Injury and Osteoarthritis Outcome questionnaire
Time frame: Until 24 months
Kujala questionnaire
Time frame: Until 24 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Until 24 months
EQ-5D-5L questionnaire
Time frame: Until 24 months
Global Rating Of Change (GROC) likert scale
Time frame: Until 24 months
Marx Activity Rating Scale (MARS) score
Time frame: Until 24 months
Morphological analysis
Time frame: Until 24 months
Collagen network organization
Time frame: Until 24 months
Osteoarthritis grading
Time frame: Until 24 months
Biovigilance
Time frame: Until 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Engineered cartilage graft (N-TEC), Autologous Matrix Induced Chondrogenesis (AMIC) and Patellofemoral Arthroplasty (PFA) in people with Patellofemoral Osteoarthritis, run by University Hospital, Basel, Switzerland at 11 sites in 8 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 27 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Italy, Switzerland, Austria, Croatia and 3 more countries. 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, MD (+41 44 387 29 77, 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)-5 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.