Engineered cartilage grafts for treating knee osteoarthritis
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
This study is testing a new cartilage treatment made from nasal cells to see if it helps people with knee osteoarthritis feel better compared to standard care options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 11 sites (Vienna and 10 other locations) |
| Trial ID | NCT06576583 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation for patients with patellofemoral osteoarthritis (PFOA). It compares N-TEC treatment to standard care options, including Autologous Matrix Induced Chondrogenesis (AMIC) for early-stage PFOA and patellofemoral arthroplasty (PFA) for late-stage PFOA. The study will assess patient outcomes through self-reported questionnaires and imaging techniques to evaluate joint regeneration. A total of 150 patients will be enrolled across multiple centers and randomized to receive either N-TEC or a comparator treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with symptomatic PFOA grades 1-4 and a baseline KOOS Pain score of less than 60.
Not a fit: Patients who are unwilling or unable to provide informed consent or those with severe chondropathy (Grade 3-4) may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain relief and joint function for patients suffering from patellofemoral osteoarthritis.
How similar studies have performed: Previous studies have shown promise in using tissue-engineered approaches for cartilage repair, suggesting potential success for this novel treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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 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 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 * 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
Where this trial is running
Vienna and 10 other locations
- Orthopedic Hospital Vienna-Speising — Vienna, Austria (Recruiting)
- University Hospital Sveti Duh — Zagreb, Croatia (Not_yet_recruiting)
- Evangelisches Waldkrankenhaus Spandau — Berlin, Germany (Not_yet_recruiting)
- Orthopedic Clinic König-Ludwig-Haus — Würzburg, Germany (Recruiting)
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy (Recruiting)
- Fondazione Policlinico Universitario Campus Bio-Medico — Rome, Italy (Not_yet_recruiting)
- Maastricht University Medical Center — Maastricht, Netherlands (Not_yet_recruiting)
- Zeromski hospital — Krakow, Poland (Recruiting)
- Department of Orthopaedics, University of Gothenburg (UGOT) — Mölndal, Sweden (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Crossklinik — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Marcus Mumme, MD
- Email: marcus.mumme@usb.ch
- Phone: +41 44 387 29 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.