Randomized, controlled, multi-center clinical trial for the treatment of osteoarthritis behind the kneecap with tissue engineered nasal cartilage implantation vs current standard of care (ENCANTO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsspital Basel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

30 Jun 2025 → ongoing

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

European Commission (Horizon Europe)

External identifiers

EU CT number

2024-513683-25-00

ClinicalTrials.gov

NCT06576583

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

This proposed phase II trial seeks to primarily define whether implantation of N-TEC will lead to a superior clinical outcome as determined by the change in KOOS-5 from baseline to 24 months than the comparator (AMIC). Data will be collected for N-TEC vs. PFA, but only minimal differences in change of KOOS-5 from baseline to 24 months between the N-TEC and the comparator are expected.

Secondary objectives 4

1. Development of the patients’ recovery over time (6, 12 and 24 months) using all questionnaires and subscores (WOMAC, MARS, Kujala, EQ-5d, VAS, KOOS, GROC, patient satisfaction).
2. Radiological analysis (MRI, X-ray) will help to determine the integration of the graft and maturation of the repair tissue as well as disease progression or remission.
3. Number of treatment failures at 24 months will be assessed.
4. Safety will be evaluated based on the number of SARs and SUSARs.

Conditions and MedDRA coding

Patellofemoral osteoarthritis

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient age is ≥18 and ≤ 70 years at time of screening
2. Symptomatic PFOA grade 1-4 according to Iwano Classification
3. Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
4. Baseline score of <75 on the KOOS-5 subjective knee evaluation
5. Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion
6. Patient is willing and able to give written informed consent

Exclusion criteria 27

1. 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
2. Patient is pregnant, breast feeding or anticipates becoming pregnant within 24 months after surgery
3. Patient is currently participating or has participated in any other clinical study involving the actually affected knee, within 3 months prior to the screening visit
4. Patient is unwilling, unable or lacking the capacity to provide informed consent
5. Patient has known current or recent history of illicit drug or alcohol
6. Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study
7. Any known allergies, especially for porcine collagen, penicillin or streptomycin
8. Patient is unable to undergo magnetic resonance imaging (MRI)
9. Prior surgical treatment of the target knee within 12 months
10. 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
11. Patient has excessive varus or valgus deformity (>5°), unless corrected during implantation
12. Nail Patella syndrome
13. Patient has a symptomatic meniscus lesion (or removal exceeding ½), as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI.
14. Patient has a body mass index (BMI) >35 kg/m2
15. Patient has chronic rheumatoid arthritis, and/or infectious arthritis
16. Patients who will likely benefit from conservative therapy, such as physiotherapy, medical training therapy and pain medication
17. Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
18. Patient has a known immunological suppressive disorder or is taking immunosuppressives
19. Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
20. Instability of anterior, posterior and/or collateral ligaments
21. The patient has a HIV/AIDS infection
22. The patient has an acute Treponema pallidum (syphilis) infection
23. The patient has an active hepatitis B or C infection with verified antigens. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded
24. Patients with increased anesthesiological and surgical risks
25. Patients with increased bleeding risk (e.g. coagulopathies)
26. Patients on anticoagulants whose anticoagulant therapy cannot be interrupted as appropriate to the given agent(s) and underlying condition
27. Patients with any active infections

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in KOOS-5 subjective score from baseline to the 24-month follow-up

Secondary endpoints 12

1. Mean KOOS subscores at all timepoints (baseline, 6, 12 and 24 months)
2. Kujala Anterior Knee Pain Scale at 6, 12 and 24 months
3. WOMAC Score at baseline, 6, 12 and 24 months
4. EQ-5D-5L at baseline 6, 12 and 24 months
5. GROC likert scale at baseline, 6, 12 and 24 months
6. Marx Activity Rating Scale at baseline, 6, 12 and 24 months
7. VAS Score at baseline, 6, 12 and 24 months
8. Patient Satisfaction Questionnaire at 24 months
9. MRI at baseline, 6, 12 and 24 months
10. X-ray at baseline, 6, 12 and 24 months
11. Safety (number of SARs and SUSARs)
12. Number of treatment failures at 24 months

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsspital Basel

Sponsor organisation

Universitaetsspital Basel

Address

Petersgraben 4

City

Basel

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

7 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 53 files

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

Application history

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