Treatment for knee osteoarthritis using engineered cartilage from nasal cells
Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Engineered Cartilage Implantation in a Randomized, Controlled, Multi-center Phase II Clinical Trial
This study is testing whether a new cartilage treatment made from nasal cells can help people with knee osteoarthritis feel less pain and improve their knee function compared to standard injections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 9 sites (Zagreb and 8 other locations) |
| Trial ID | NCT06163573 on ClinicalTrials.gov |
What this trial studies
This phase II trial aims to evaluate the effectiveness of autologous nasal chondrocyte tissue engineered cartilage (N-TEC) in treating patellofemoral osteoarthritis compared to standard platelet-rich plasma (PRP) injections. The study will assess patient-reported outcomes using the Knee Osteoarthritis Outcome Score (KOOS) and verify tissue regeneration through imaging techniques. Participants will be monitored over 24 months to determine improvements in pain and overall knee function. The trial seeks to demonstrate that N-TEC can provide significant clinical benefits and modify the disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals with symptomatic patellofemoral osteoarthritis grade 1-3 and a KOOS Pain score of less than 60.
Not a fit: Patients with advanced osteoarthritis in the tibiofemoral compartment or significant knee deformities may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve knee function for patients with patellofemoral osteoarthritis.
How similar studies have performed: Previous studies have indicated potential success with tissue-engineered cartilage approaches, but this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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 * Non-surgical standard of care options except for PRP have been exhausted. 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) * 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°) * 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 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. * 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
Where this trial is running
Zagreb and 8 other locations
- Poliklinika Ivković — Zagreb, Croatia (Recruiting)
- Poliklinika Ortho Plus — Zagreb, Croatia (Recruiting)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (Not_yet_recruiting)
- Orthopädische Klinik König-Ludwig-Haus — Würzburg, Germany (Not_yet_recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Crossklinik — Basel, Switzerland (Recruiting)
- Hôpitaux universitaires de Genève — Geneva, Switzerland (Recruiting)
- Ospedale Regionale di Lugano — Lugano, Switzerland (Recruiting)
- Sportclinic, Klinik Hirslanden — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marcus Mumme, Dr — University Hospital, Basel, Switzerland
- Study coordinator: Marcus Mumme, Dr
- Email: marcus.mumme@usb.ch
- Phone: 0041615565885
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.