Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

Patellofemoral Osteoarthritis Clinical Trial

Official title:

Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Engineered Cartilage Implantation in a Randomized, Controlled, Multi-center Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163573
• Other study ID #: 2023-508640-21-00
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2024
• Est. completion date: September 2029

Study information

• Verified date: June 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Marcus Mumme, Dr
• Phone: 0041615565885
• Email: marcus.mumme[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

Intra operative exclusion criteria:

• Advanced OA of tibiofemoral compartment of the knee

• 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 >1) or MRI or pain in the tibiofemoral joint (clinical examination)

• Excessive varus or valgus deformity (>5°)

• Symptomatic meniscus lesion, 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

• Patellar dislocation in the last 2 years

Related Conditions & MeSH terms

• Osteoarthritis
• Patellofemoral Osteoarthritis

Intervention

Biological:
• N-TEC
Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.
• Platelet rich plasma
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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Orthopädische Klinik König-Ludwig-Haus	Würzburg
Switzerland	Crossklinik	Basel
Switzerland	University Hospital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Hôpitaux universitaires de Genève	Genève
Switzerland	Ospedale Regionale di Lugano	Lugano
Switzerland	Schulthess Klinik	Zurich
Switzerland	Sportclinic, Klinik Hirslanden	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland, Swiss National Science Foundation, Wuerzburg University Hospital

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months
Secondary	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)	until 24 months
Secondary	Iwano classification	Osteoarthritis grade determined based on X-rays according to Iwano classification (grades 1 to 4).	until 24 months
Secondary	Kellgren Lawrence classification	Osteoarthritis grade determined based on X-rays according to Kellgren Lawrence classification (grades 1 to 4).	until 24 months
Secondary	MOCART score	Magnetic Resonance Imaging (MRI) of Cartilage Repair Tissue (MOCART) score: radiological evaluation of repair tissue. Minimum score:0; maximum score: 100.	until 24 months
Secondary	Biovigilance	Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment.	until 24 months
Secondary	Kujala self reported questionnaire	Anterior Knee Pain scale. Minimum score: 0 Maximum score: 100 (no knee problems)	until 24 months
Secondary	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.	until 24 months
Secondary	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).	until 24 months