Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

NCT06163573 | Recruiting Phase 2

• 1 other identifier: 2023-508640-21-00
• Study Type: interventional
• Target: 75
• Locations: 3 countries
• Sites: 9

Brief 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.

Conditions

Patellofemoral Osteoarthritis

Keywords

Nasal chondrocytes; Tissue engineering; Knee cartilage; Patellofemoral osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Biovigilance

  until 24 months

• Knee Injury and Osteoarthritis Outcome questionnaire

  until 24 months

• Iwano classification

  until 24 months

• Kellgren Lawrence classification

  until 24 months

• MOCART score

  until 24 months

Other Outcomes (4)

• Activity level

  Until 24 months

• Quality-adjusted life-years (QALY) outcome

  Until 24 months

• One Leg Hop test

  Until 24 months

Study Arms (2)

N-TEC

EXPERIMENTAL

N-TEC is based on autologous nasal chondrocytes expanded and further cultured on type I/III collagen membranes for 2 weeks to allow cells to produce extracellular matrix containing cartilage specific proteins. The IMP is implanted in the knee at the patellofemoral joint.

Biological: N-TEC

Platelet Rich Plasma

ACTIVE COMPARATOR

Total of 3 injections of about 5 ml each of platelet rich plasma (PRP), autologous Conditioned Plasma ACP®, Arthrex, one injection per week for three consecutive weeks.

Biological: Platelet rich plasma

Interventions

N-TEC BIOLOGICAL

Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.

Also known as: Engineered cartilage graft

N-TEC

Platelet rich plasma BIOLOGICAL

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.

Also known as: PRP

Platelet Rich Plasma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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 rehabilitation regimen.
• 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.

You may not qualify if:

• 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).
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator
• University Hospital Wurzburg: collaborator

Study Sites (9)

Poliklinika Ivković

Zagreb, 10000, Croatia

RECRUITING

Poliklinika Ortho Plus

Zagreb, 10000, Croatia

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

Orthopädische Klinik König-Ludwig-Haus

Würzburg, 97074, Germany

NOT YET RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Crossklinik

Basel, 4054, Switzerland

RECRUITING

Hôpitaux universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

Ospedale Regionale di Lugano

Lugano, 6962, Switzerland

RECRUITING

Sportclinic, Klinik Hirslanden

Zurich, 8032, Switzerland

RECRUITING

Related Publications (1)

• Seitz S, Lehoczky G, Wixmerten A, Schuster-Amft C, Miot S, Shrestha K, Schaedelin S, Martin I, Mumme M. Treatment of patellofemoral osteoarthritis with nasal chondrocyte-based engineered cartilage implantation in a randomised, controlled, multicentre phase II clinical trial: protocol for a randomised controlled trial. BMJ Open. 2025 Aug 21;15(8):e106140. doi: 10.1136/bmjopen-2025-106140.

  PMID: 40840982 DERIVED

Study Officials

• Marcus Mumme, Dr

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Mumme, Dr

CONTACT

0041615565885; marcus.mumme@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group: biological: Autologous nasal chondrocytes and ECM proteins Control group: Platelet rich plasma injections

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 11, 2023
• Study Start: June 6, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); CH (5); CR (2)