NCT01222559

Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects

Prospective, Randomised, Open Label, Multicentre Phase-III Clinical Trial to Compare the Efficacy and Safety of the Treatment With the Autologous Chondrocyte Transplantation Product co.Don Chondrosphere (ACT3D-CS) With Microfracture in Subjects With Cartilage Defects of the Knee With a Defect Size Between 1 an 4 cm2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: co.don AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, phase III, multicenter, open label, randomised clinical trial of co.don chondrosphere®, a three-dimensional autologous chondrocyte transplantation product (ACT3D-CS)compared to the procedure of microfracture (MF)in the treatment of cartilage defects of knee joints. After screening visit patients were booked for arthroscopy and at that time they were randomised to either ACT3D-CS with co.don chondrosphere® (Group A) or to MF(Group B), a marrow-stimulating method based on the penetration of the subchondral bone plate at the bottom of the cartilage defect. At the time of arthroscopy Patients of group B had their procedure of MF (treatment surgery) and patients of group A had their cells harvested from healthy cartilage. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional spheroids , that are transplanted in an open knee procedure (treatment surgery)into the defect. Patients subsequently followed the same rehabilitation program and had post-surgery visits. After the 12-month-visit a interim analyses will be performed and the 24-month-visit is defined as final assessment. Then patients have follow-up assessments up to 60 months post-treatment-surgery.

Detailed description

see above

Conditions

• Articular Cartilage Lesion of the Femoral Condyle

Interventions

Type	Name	Description
DRUG	co.don chondrosphere®	co.don chondrosphere® are spheroids in suspension, developed from autologous chondrocytes. The dose depends on the size of the defect, recommended dose is 10-70 spheroids/cm2 defect.
PROCEDURE	Microfracture	A procedure in which the subchondral bone is perforated to allow a bloodcloth to form new tissue.

Timeline

• Start date: 2010-10-01
• Primary completion: 2017-09-01
• Completion: 2020-02-01
• First posted: 2010-10-18
• Last updated: 2021-01-27

Locations

12 sites across 2 countries: Germany, Poland