Actively Recruiting
Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.
Led by University Hospital, Basel, Switzerland · Updated on 2026-03-24
150
Participants Needed
11
Research Sites
233 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
C
Clinical Trial Unit, University Hospital Basel, Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
ENCANTO is a randomized, controlled, multi-center phase II clinical trial for the treatment of patellofemoral osteoarthritis (PFOA) with an Advanced Therapy Medicinal Product (ATMP), nasal chondrocyte-based tissue engineered cartilage (N-TEC) implantation in comparison with current standard of care depending on the stage of osteoarthritis. The goal of this phase II trial is to evaluate the efficacy of N-TEC treatment in comparison to an active comparator Autologous Matrix Induced Chondrogenesis (AMIC) for early stage PFOA or patellofemoral arthroplasty (PFA) for late stage PFOA. The N-TEC engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.
CONDITIONS
Official Title
Implantation of Engineered Cartilage Grafts for Treatment of Patellofemoral Osteoarthritis Versus Surgical Comparators.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at screening
- Symptomatic patellofemoral osteoarthritis grade 1-4 by Iwano Classification
- Chondropathy grade 3-4 in patella, trochlea femoris, or both by ICRS classification
- Baseline KOOS-5 subjective knee score below 75
- Free knee joint range of motion or no more than 5° extension loss and minimum 125° flexion
- Willing and able to give informed consent, comply with study requirements, attend follow-ups, and complete rehabilitation
- Minimum blood values for women: Hemoglobin 120g/l, Platelets 150G/l, INR below 1.3
- Minimum blood values for men: Hemoglobin 140g/l, Platelets 150G/l, INR below 1.3
- Inadequate response to non-pharmacological interventions and first-line pharmacological treatments such as topical NSAIDs
You will not qualify if you...
- Investigator, study staff, or relatives involved in the study conduct
- Unable or unwilling to provide informed consent
- Unable to undergo MRI
- Knee surgery on target knee within last 12 months except diagnostic arthroscopy with lavage or debridement
- Degenerative joint disease of tibiofemoral joint grade greater than 2 or tibiofemoral joint pain
- Excessive varus or valgus deformity greater than 5° unless corrected during implantation
- Symptomatic meniscus lesion or removal exceeding half the meniscus
- Body mass index over 35 kg/m²
- Chronic rheumatoid arthritis or infectious arthritis
- Painful or disabling disease of spine, hips, or lower limbs affecting knee evaluation
- Known immunosuppressive disorder or systemic immunosuppressive treatment
- Intra-articular injections into affected knee within last 3 months
- Instability of knee ligaments
- HIV/AIDS infection
- Acute syphilis infection
- Active hepatitis B or C infection (cured infections not excluded)
- Pregnancy, breastfeeding, or planning pregnancy within 24 months after surgery
- Participation in another clinical study within last 3 months
- History of illicit drug or alcohol abuse or dependence
- Other conditions making patient unsuitable per investigator
- Known allergies to porcine collagen, penicillin, or streptomycin
- Nail-patella syndrome
- Likely to benefit from conservative therapy like physiotherapy or pain medication
- Increased anesthesiological or surgical risks
- Increased bleeding risk or uninterruptible anticoagulant therapy
- Any active infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Orthopedic Hospital Vienna-Speising
Vienna, Austria, 1130
Actively Recruiting
2
University Hospital Sveti Duh
Zagreb, Croatia, 10000
Not Yet Recruiting
3
Evangelisches Waldkrankenhaus Spandau
Berlin, Germany, 13589
Not Yet Recruiting
4
Orthopedic Clinic König-Ludwig-Haus
Würzburg, Germany, 97074
Actively Recruiting
5
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy, 20157
Actively Recruiting
6
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
Not Yet Recruiting
7
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
8
Zeromski hospital
Krakow, Poland, 31-913
Actively Recruiting
9
Department of Orthopaedics, University of Gothenburg (UGOT)
Mölndal, Sweden, 80
Actively Recruiting
10
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
11
Crossklinik
Basel, Switzerland, 4054
Actively Recruiting
Research Team
M
Marcus Mumme, MD
CONTACT
G
Gyözö Lehoczky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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