Treatment of osteoarthritis behind the kneecap with tissue engineered nasal cartilage in a randomized, controlled, multicenter clinical trial

2023-508640-21-00 Protocol PFOA II Therapeutic exploratory (Phase II) Authorised, recruiting

Start 22 Sep 2025 · Status Authorised, recruiting · 2 EU/EEA countries · 4 sites · Protocol PFOA II

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruiting
Participants planned 89
Countries 2
Sites 4

Patellofemoral osteoarthritis

Mean KOOS Pain Change from baseline to 24 months between groups

Key facts

Sponsor
Universitaetsspital Basel
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
22 Sep 2025 → ongoing
Decision date (initial)
2025-03-10
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Swiss national science foundation

External identifiers

EU CT number
2023-508640-21-00
ClinicalTrials.gov
NCT06163573

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Mean KOOS Pain Change from baseline to 24 months between groups

Secondary objectives 12

  1. Mean KOOS subscales (Symptoms, Activity of daily living (ADL), Sports & Recreation (Sports), Quality of Life (QOL))
  2. Number of subjects non-responding (improvement in KOOS Pain < 13 on a scale of 0-100) at 24 months
  3. Number of SARs and SUSARs to assess safety
  4. Global Rating Of Change (GROC) likert scale at 6, 12 and 24 months
  5. Marx Activity Rating Scale (MARS) at 6, 12 and 24 months
  6. MRI Osteoarthritis Knee Score (MOAKS) for radiological evaluation of osteoarthritis at 6, 12 and 24 months
  7. MRI of Cartilage Repair Tissue (MOCART) for radiological evaluation of repair tissue at 6, 12 and 24 months
  8. Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification at 6 months, 12 and 24 months
  9. Kujala Anterior Knee Pain Scale at 6, 12, 24 months
  10. WOMAC at 6, 12, 24 months
  11. EQ-5D at 6,12,24 months
  12. VAS at 6, 12 and 24 months

Conditions and MedDRA coding

Patellofemoral osteoarthritis

VersionLevelCodeTermSystem organ class
21.1 LLT 10023476 Knee osteoarthritis 10028395

Regulatory references

Scientific advice from competent authorities
Swissmedic Swiss Agency for Therapeutic Products, Paul-Ehrlich-Institut
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Symptomatic PFOA grade 1-3 according to Iwano Classification
  2. Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
  3. Baseline score of <60 on the KOOS Pain subjective knee evaluation.
  4. Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion
  5. Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR<1.3
  6. Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR<1.3
  7. Non-surgical standard of care options except for PRP have been exhausted

Exclusion criteria 10

  1. Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months)
  2. 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)
  3. Excessive varus or valgus deformity (>5°)
  4. Symptomatic meniscus lesion, as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI
  5. Patient has a body mass index (BMI) >35 kg/m2
  6. Patient has chronic rheumatoid arthritis, and/or infectious arthritis
  7. Patients with any active infections
  8. patients on anticoagulants whose anticoagulant therapy cannot be interrupted as appropriate to the given agent(s) and underlying condition
  9. patients with increased bleeding risk (e.g. coagulopathies)
  10. patients with increased anesthesiological and surgical risks (e.g. known or predicted difficult airway, myocardial infarction <60 days prior to surgery)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Comparison of mean change in KOOS Pain from baseline to 24 months between groups (N-TEC – PRP > 15)

Secondary endpoints 13

  1. Mean KOOS Pain at 6 and 12 months
  2. Mean KOOS subscales (Symptoms, Activity of daily living (ADL), Sports & Recreation (Sports), Quality of Life (QOL)) at 6, 12 and 24 months
  3. Kujala Anterior Knee Pain Scale at 6, 12 and 24 months
  4. WOMAC Score at 6, 12 and 24 months
  5. EQ-5D-5L at 6, 12 and 24 months
  6. VAS at 6, 12 and 24 months
  7. Number of treatment failures and subjects non-responding (improvement in KOOS Pain < 13 on a scale of 0-100) at 24 months
  8. Global Rating Of Change (GROC) likert scale at 6, 12 and 24 months
  9. MARS at 6, 12 and 24 months
  10. MRI Osteoarthritis Knee Score (MOAKS) for radiological evaluation of osteoarthritis at 6, 12 and 24 months
  11. MRI of Cartilage Repair Tissue (MOCART) for radiological evaluation of repair tissue at 6, 12 and 24 months
  12. Osteoarthritis grade according to Iwano and Kellgren/Lawrence classification at 6, 12 and 24 months
  13. Number of SARs and SUSARs to assess safety

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

N-Tec

PRD11122973 · Product

Active substance
N-Tec
Pharmaceutical form
IMPLANT
Route of administration
IMPLANTATION
Max daily dose
40 cm2 square centimeter
Max total dose
40 cm2 square centimeter
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
UNIVERSITAETSSPITAL BASEL
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsspital Basel

6 Total trials 5 Recruiting
Academic / Non-commercial
Sponsor organisation
Universitaetsspital Basel
Address
Zlf, Hebelstrasse 20 Hebelstrasse 20
City
Basel Town
Postcode
4031
Country
Switzerland

Scientific contact point

Organisation
Universitaetsspital Basel
Contact name
Ivan Martin

Public contact point

Organisation
Universitaetsspital Basel
Contact name
Ivan Martin

Locations

2 EU/EEA countries · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Croatia Ongoing, recruiting 14 2
Germany Authorised, recruitment pending 16 2
Rest of world
Switzerland
 — 59 —

Investigational sites

Croatia

2 sites · Ongoing, recruiting
Poliklinika Ivković, d.o.o.
Orthopedics and Traumatology, Prilaz Gjure Deželića 43, 10000, Zagreb
Poliklinika ORTHO PLUS, d.o.o.
Orthopedics, Hektorovićeva ulica 2, 10000, Zagreb

Germany

2 sites · Authorised, recruitment pending
Medical Center - University Of Freiburg
Klinik für Orthopädie und Unfallchirurgie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Koenig-Ludwig-Haus Orthopaedische Klinik
Schwerpunkt Sportorthopädie und Arthroskopische Operationen, Brettreichstrasse 11, Frauenland, Wuerzburg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Croatia 2025-09-22 2025-09-22

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-508640-21-00 4
Protocol (for publication) D1_Protocol 2023-508640-21-00_signature page 1
Protocol (for publication) D4 Patient facing document_Questionnaire KOOS de 1
Protocol (for publication) D4 Patient facing document_Questionnaire WOMAC_hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_EQ-5D-5L_de 1
Protocol (for publication) D4 Patient facing document_Questionnaire_GROC_de 1
Protocol (for publication) D4 Patient facing document_Questionnaire_GROC_hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_KOOS_hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_Kujala de 1
Protocol (for publication) D4 Patient facing document_Questionnaire_Kujala hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_MARX Scale hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_Marx_Score de 1
Protocol (for publication) D4 Patient facing document_Questionnaire_Satisfaction questionnaire_hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_VAS_de 1
Protocol (for publication) D4 Patient facing document_Questionnaire_VAS_hr 1
Protocol (for publication) D4 Patient facing document_Questionnaire_WOMAC de 1
Protocol (for publication) D4 Patient facing document_Satisfaction questionnaire_de 1
Protocol (for publication) D4 Patient facing documents_Questionnaire EQ-5D-5L _hr 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K2_Recruitment material_Homepage_DE_2025-06-23 1
Recruitment arrangements (for publication) K2_Recruitment material_Homepage_EN_2025-06-23 1
Recruitment arrangements (for publication) K2_Recruitment material_Homepage_F_2025-06-23 1
Recruitment arrangements (for publication) K2_Recruitment material_Homepage_IT_2025-06-23 1
Subject information and informed consent form (for publication) L1_SIS and ICF 4
Subject information and informed consent form (for publication) L1_SIS and ICF KLH 1
Subject information and informed consent form (for publication) L1_SIS and ICF KLH 6
Subject information and informed consent form (for publication) L1_SIS and ICF KLH_additional samples 1
Subject information and informed consent form (for publication) L1_SIS and ICF UKLFR 1
Subject information and informed consent form (for publication) L1_SIS and ICF UKLFR 6
Subject information and informed consent form (for publication) L1_SIS and ICF UKLFR_additional samples 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_Germany_deutsch_2023-508640-21-00 4

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-21 Germany Acceptable
2024-09-26
 2024-09-27
2 SUBSEQUENT ADDITION OF MSC APP-2 2024-11-25 Acceptable
2024-09-26
 2025-03-10
3 SUBSTANTIAL MODIFICATION SM-1 2025-07-01 Germany Acceptable
2025-08-28
 2025-08-29
4 SUBSTANTIAL MODIFICATION SM-2 2025-10-13 Acceptable 2026-01-30

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