Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

ConditionPatellofemoral Osteoarthritis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

75 Participants

are divided into 2 treatment groups

Group A: N-TECExperimental treatment 1 intervention

Group B: Platelet Rich PlasmaActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

24 months

Secondary outcomes

Biovigilance

Number of adverse events, adverse reactions based on severity, expectedness and relationship to treatment.

Time frame

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)

Time frame

until 24 months

Iwano classification

Osteoarthritis grade determined based on X-rays according to Iwano classification (grades 1 to 4).

Time frame

until 24 months

Kellgren Lawrence classification

Osteoarthritis grade determined based on X-rays according to Kellgren Lawrence classification (grades 1 to 4).

Time frame

until 24 months

Other outcomes

Activity level

Patients will wear activity trackers for defined time periods to determine their activity level and assess if there is a correlation between the activity level and the clinical outcome.

Time frame

Until 24 months

Quality-adjusted life-years (QALY) outcome

Quality-adjusted life-years (QALY) is a measure of health outcome that combines the quantity and quality of life into a single value. It represents the value of an individual's health. QALY is used in cost-effectiveness analyses to compare the value of different healthcare interventions.

Time frame

Until 24 months

One Leg Hop test

The One Leg Hop test will be performed after patients had followed the physiotherapy program. This functional movement assessment is used to evaluate lower limb strength, power, and neuromuscular control. It involves hopping on one leg as far as possible and landing on the same leg while maintaining balance.

Time frame

Until 24 months

Y Balance test

The Y-Balance Test will be performed after patients had followed the physiotherapy program. It is a standardized test for assessing dynamic balance and movement quality, particularly in the lower extremities. It is used to assess injury risk and support post-injury rehabilitation.

Time frame

Until 24 months