NCT03219307

NOVOCART 3D Treatment Following Microfracture Failure

Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aesculap Biologics, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Detailed description

This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

Conditions

• Articular Cartilage Defect

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NOVOCART 3D	Matrix associated autologous chondrocyte implant

Timeline

• Start date: 2018-11-30
• Primary completion: 2026-01-01
• Completion: 2029-01-01
• First posted: 2017-07-17
• Last updated: 2025-03-21

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study