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

NCT01222559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-01-27

No results posted yet for this study

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.

Conditions

  • Articular Cartilage Lesion of the Femoral Condyle

Interventions

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.

Sponsors & Collaborators

  • co.don AG

    lead INDUSTRY

Principal Investigators

  • Stefan Fickert, Ph.D. · Universitätsmedizin Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2017-09-30
Completion
2020-02-29

Countries

  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222559 on ClinicalTrials.gov