NCT03319797

NOVOCART® Inject Plus for Cartilage Defects of the Knee

Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject Plus in the Treatment of Cartilage Defects of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tetec AG · Industry
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject plus in the Treatment of Cartilage Defects of the Knee. The primary objective of this trial is to demonstrate efficacy of NOVOCART® Inject plus for the treatment of cartilage defects of the knee based on the Knee injury and Osteoarthritis Outcome Score (KOOS) responder rate 24 month after transplantation.

Detailed description

The present study is a prospective, multicenter, single-arm phase III clinical trial to evaluate the efficacy and safety of NOVOCART® Inject plus in the treatment of patients with focal cartilage defects of the knee (medial or lateral femoral condyle or tibial plateau, trochlea or patella). The study will include adult patients between 18 and 65 years of age and pediatric patients (14 to 17 years) with closed epiphysis. A total of 96 patients will be enrolled in the NOVOCART® Inject plus trial at about 20 clinical study sites in Europe. It is expected that each study site will enroll 3 to 9 patients. The trial will consist of three phases (including screening, treatment and follow-up phase) with a maximum duration of 5 years and 4 months. The treatment with NOVOCART® Inject plus requires 2 surgeries. During the first surgery autologous chondrocytes for transplant production will be harvested arthroscopically, then NOVOCART® Inject plus will be transplanted during a second surgery about 3 to 4 weeks later. In general, NOVOCART® Inject plus transplantation can be performed arthroscopically. However, depending on the defect localization, mini-arthrotomy may be indicated. Eligibility will be assessed preoperatively at visit 1 (screening) and (up to a maximum of 3 months later) intraoperatively during the first arthroscopy (visit 2). During visit 2, cartilage biopsy samples will be taken from eligible patients and sent to TETEC AG for NOVOCART® Inject plus manufacturing. Transplantation will then be performed during a second arthroscopy 3 to 4 weeks later (visit 3). All patients will be followed up for 5 years post NOVOCART® Inject plus transplantation with assessments at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined in the schedule of events and treatment at the end of this synopsis. NOVOCART® Inject plus will be applied in conjunction with a rehabilitation program according to the rehabilitation regimen defined in the clinical study protocol. The primary and secondary endpoints will be assessed after a follow-up of 24 month post NOVOCART® Inject plus transplantation (primary analysis). Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis). An interim analysis of efficacy and safety data will be performed when 63 patients (66% of the planned number of patients) are evaluable for the primary endpoint.

Conditions

• Cartilage Defects of the Knee

Interventions

Type	Name	Description
DRUG	NOVOCART® Inject plus	Treatment with NOVOCART® Inject plus (Autologous chondrocyte implantation)

Timeline

• Start date: 2017-10-10
• Primary completion: 2021-02-22
• Completion: 2024-02-22
• First posted: 2017-10-24
• Last updated: 2024-08-14

Locations

20 sites across 5 countries: Czechia, Germany, Hungary, Lithuania, Switzerland