Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee (NINJA)

Tissue Engineering Technologies (TETEC)

Status: Not yet enrolling

Conditions: Cartilage Disease

Treatments: Drug: NOVOCART Inject

Study type: Observational

Funder types: Industry

Identifiers

NCT05391841

AAG-O-H-2123

Details and patient eligibility

About

The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with radiologically proven closed epiphyseal growth plates.

Full description

In this non-interventional study NOVOCART® Inject, which is marketed in Germany under a license according to Section 4b of the AMG, will be used in routine clinical practice according to the current authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® Inject may only be used by physicians who are trained on the product. The treatment with NOVOCART® Inject requires two surgeries. During the first surgery cartilage tissue will be harvested arthroscopically and sent to TETEC AG for NOVOCART® Inject manufacturing, then NOVOCART® Inject will be transplanted during a second surgery about 3 to 4 weeks later.

All patients will be followed up for 5 years post NOVOCART® Inject implantation and data will be collected preoperatively and at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.

NOVOCART® Inject post treatment rehabilitation should follow the recommendations given in the SmPC and during product training.

The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® Inject implantation (primary analysis).

Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis).

The collected data will be documented using dedicated case report forms (CRFs) which are created by TETEC AG.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients (< 18 years of age at implantation)
• Closure of the epiphysis adjacent to the biopsy harvest site or the defect to be treated confirmed by an adequate imaging modality
• Localized full-thickness cartilage defect (ICRS grade III or IV) of the knee
• Medicinal indication for NOVOCART® Inject treatment

Exclusion criteria

see NOVOCART Inject SmPC