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New treatment option for Patellofemoral Osteoarthritis
Official title Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
ClinicalTrials.gov ID: NCT06163573
What this study is testing
What is N-TEC?
N-TEC is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for patellofemoral osteoarthritis.
Also referred to as Engineered cartilage graft.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly...
- 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...
- Radiologically apparent degenerative joint disease of the tibiofemoral joint as determined by X-ray (Kellgren and Lawrence grade \> 2) or MRI or pain...
- Patient has excessive varus or valgus deformity (\>5°)
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zagreb, Croatia
- Freiburg im Breisgau, Germany
- Würzburg, Germany
- Basel, Switzerland
- Geneva, Switzerland
- Lugano, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zagreb, Croatia; Freiburg im Breisgau, Germany; Würzburg, Germany; Basel, Switzerland; Geneva, Switzerland; Lugano, Switzerland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.