Evaluation of matrix-associated autologous chondrocyte transplantation as treatment of cartilage lesions of the knee joint

Matrix-associated autologous chrondrocyte transplantation for grade four cartilage lesions of the knee joint - clinical and radiological outcome in correlation to the initial cell count of the chondrocyte graft - MACT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003584-11-AT

Enrollment

Registered

2015-09-04

Start date

2015-12-11

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage lesion MedDRA version: 18.0 Level: LLT Classification code 10072638 Term: Articular cartilage defect System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification code 10064113 Term: Cartilage allograft System Organ Class: 100000004865

Interventions

Trade Name: ATMP-Matrix associated autologous chondrocyte transplantation Product Name: MACT Pharmaceutical Form: Implantation matrix INN or Proposed INN: MACT Other descriptive name: MATRIX-INDUCED A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Grade four chondral or osteochondral lesion of the knee joint, treated with MACT - Defect size > 2cm² - Patient age at the date of follow up: 18-65 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - Patient age at the date of follow up 65 years - Current history of knee instability - Malalignment (varus/valgus = 5° and not corrected during surgery or despite correction) - Previous surgeries or injuries to the hyaline cartilage of the affected knee joint - Congenital malformation of the lower extremity - Medical secondary diagnosis which could influence cartilage metabolism - Medical therapies which could influence cartilage metabolism - Secondary diagnosis (e.g. neurological) which could influence physiological weight bearing - Contraindication to MRI - Patient is not able to obtain informed consent due to physical or mental disability - Patient has no legal capacity

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to evaluate the clinical and radiological outcome (MRT) after MACT and to correlate these findings with the initial cell count of the chondrocyte graft. What is more, further knowledge about additional factors influencing the outcome of the surgery may be gained. This pilot study could provide valuable data for the design of a prospective randomized clinical trial.;Secondary Objective: Localization of the lesion (medial/lateral femural condyle, patella, trochlea) Age and sex Lesion size;Primary end point(s): - Clinical outcome: Short Form 36 (SF-36), WOMAC, IKDC - Radiological outcome: MOCART-Score assessed on MRI - Initial cell count of the chondrocyte graft (f.e. according to the report of Novocart 3D-XL, or as available) ;Timepoint(s) of evaluation of this end point: 5-9 years after surgery.	—

Measure

Time frame

Main Objective: The objective of this study is to evaluate the clinical and radiological outcome (MRT) after MACT and to correlate these findings with the initial cell count of the chondrocyte graft. What is more, further knowledge about additional factors influencing the outcome of the surgery may be gained. This pilot study could provide valuable data for the design of a prospective randomized clinical trial.;Secondary Objective: Localization of the lesion (medial/lateral femural condyle, patella, trochlea) Age and sex Lesion size;Primary end point(s): - Clinical outcome: Short Form 36 (SF-36), WOMAC, IKDC - Radiological outcome: MOCART-Score assessed on MRI - Initial cell count of the chondrocyte graft (f.e. according to the report of Novocart 3D-XL, or as available) ;Timepoint(s) of evaluation of this end point: 5-9 years after surgery.

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Secondary

Measure	Time frame
Secondary end point(s): - Localization of the lesion (medial/lateral femural condyle, patella, trochlea) - Age and sex ;Timepoint(s) of evaluation of this end point: 9 years after Initial surgery.	—

Countries

Austria

Contacts

Public ContactUniv.-Klinik für Unfallchirurgie

Univ.-Klinik für Unfallchirurgie

004351250480752

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026