Actively Recruiting
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
Led by University Hospital, Basel, Switzerland · Updated on 2026-03-24
75
Participants Needed
9
Research Sites
273 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age is 18 and 65 years at time of screening.
- Symptomatic patellofemoral osteoarthritis (PFOA) grade 1-3 according to Iwano Classification.
- Chondropathy grade 3-4 according to ICRS classification of the patella, trochlea femoris, or both.
- Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score below 60.
- Free range of motion of the affected knee joint or 5 of extension loss and minimum 125 flexion.
- Willing and able to give written informed consent and comply with all study requirements, including follow-up visits and rehabilitation.
- Minimum hemoglobin 120 g/l for women and 140 g/l for men.
- Minimum platelets 150 G/l.
- INR less than 1.3.
- Non-surgical standard care options except platelet rich plasma (PRP) have been exhausted.
You will not qualify if you...
- Investigator, sub-investigator, research staff, or relatives involved in the study.
- Unable to understand patient information.
- Unable to undergo magnetic resonance imaging (MRI).
- Prior surgical treatment of the target knee within 12 months (except diagnostic arthroscopy with debridement and lavage).
- Degenerative joint disease of the tibiofemoral joint (Kellgren and Lawrence grade > 2) or related pain.
- Excessive varus or valgus deformity (>5).
- Patellar dislocation in the affected knee within the last 2 years.
- Symptomatic meniscus lesion or removal exceeding half.
- Body mass index (BMI) over 35 kg/m2.
- Chronic rheumatoid arthritis or infectious arthritis.
- Painful or disabling disease of spine, hips, or lower limbs interfering with knee evaluation.
- Known immunosuppressive disorder or use of immunosuppressives.
- Intra-articular injections into affected knee within last 3 months.
- Instability of anterior or posterior collateral ligaments.
- HIV/AIDS infection.
- Acute syphilis infection.
- Active hepatitis B or C infection with verified antigens.
- Pregnant, breastfeeding, or planning pregnancy within 24 months after surgery.
- Participation in another clinical study within 3 months prior to screening.
- History of illicit drug or alcohol abuse or dependence.
- Any other condition making patient unsuitable per investigator judgment.
- Known allergies to porcine collagen, penicillin, or streptomycin.
- Increased anesthesiological or surgical risks.
- Increased bleeding risk or anticoagulant therapy that cannot be interrupted.
- Any active infections.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Poliklinika Ivković
Zagreb, Croatia, 10000
Actively Recruiting
2
Poliklinika Ortho Plus
Zagreb, Croatia, 10000
Actively Recruiting
3
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
4
Orthopädische Klinik König-Ludwig-Haus
Würzburg, Germany, 97074
Not Yet Recruiting
5
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
6
Crossklinik
Basel, Switzerland, 4054
Actively Recruiting
7
Hôpitaux universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
8
Ospedale Regionale di Lugano
Lugano, Switzerland, 6962
Actively Recruiting
9
Sportclinic, Klinik Hirslanden
Zurich, Switzerland, 8032
Actively Recruiting
Research Team
M
Marcus Mumme, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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