NCT01222559

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

Completed Phase 3 Last updated 26 January 2021

What this trial tests

Phase 3 trial testing co.don chondrosphere® in Articular Cartilage Lesion of the Femoral Condyle in 102 participants. Completed in 1 February 2020.

Timeline

1 October 2010

Primary endpoint
1 September 2017

1 February 2020

Quick facts

Lead sponsor	co.don AG
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	1 October 2010
Primary completion	1 September 2017
Estimated completion	1 February 2020
Sites	12 locations across Germany, Poland

Drugs / interventions tested

• co.don chondrosphere® — full drug profile →
• Microfracture

Conditions studied

• Articular Cartilage Lesion of the Femoral Condyle — all drugs for Articular Cartilage Lesion of the Femoral Condyle →

Sponsor

co.don AG — full company profile →

Who can join

Adults 18 to 50, any sex, with Articular Cartilage Lesion of the Femoral Condyle. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change of overall KOOS
  Time frame: 24 months after the end of the respective treatment
  Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score)from baseline (Day 0)to final assessment compared between ACT3D-CS (co.don chondrosphere) and MF (microfracture)

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell-based tissue engineering strategies used in the clinical repair of articular cartilage.
   Huang BJ, Hu JC, Athanasiou KA. · · 2016 · cited 274× · PMID 27177218 · DOI 10.1016/j.biomaterials.2016.04.018
2. Trends in clinical trials for articular cartilage repair by cell therapy.
   Negoro T, Takagaki Y, Okura H, Matsuyama A. · · 2018 · cited 71× · PMID 30345076 · DOI 10.1038/s41536-018-0055-2
3. A Prospective, Randomized, Open-Label, Multicenter, Phase III Noninferiority Trial to Compare the Clinical Efficacy of Matrix-Associated Autologous Chondrocyte Implantation With Spheroid Technology Versus Arthroscopic Microfracture for Cartilage Defects of the Knee.
   Niemeyer P, Laute V, Zinser W, Becher C, et al · · 2019 · cited 55× · PMID 31317047 · DOI 10.1177/2325967119854442
4. Insights into the present and future of cartilage regeneration and joint repair.
   Evenbratt H, Andreasson L, Bicknell V, Brittberg M, et al · · 2022 · cited 29× · PMID 35106664 · DOI 10.1186/s13619-021-00104-5
5. Matrix-Associated Autologous Chondrocyte Implantation with Spheroid Technology Is Superior to Arthroscopic Microfracture at 36 Months Regarding Activities of Daily Living and Sporting Activities after Treatment.
   Hoburg A, Niemeyer P, Laute V, Zinser W, et al · · 2021 · cited 27× · PMID 31893951 · DOI 10.1177/1947603519897290
6. Role of Matrix-Associated Autologous Chondrocyte Implantation with Spheroids in the Treatment of Large Chondral Defects in the Knee: A Systematic Review.
   Vonk LA, Roël G, Hernigou J, Kaps C, et al · · 2021 · cited 23× · PMID 34281202 · DOI 10.3390/ijms22137149
7. Clinical outcome is significantly better with spheroid-based autologous chondrocyte implantation manufactured with more stringent cell culture criteria.
   Eschen C, Kaps C, Widuchowski W, Fickert S, et al · · 2020 · cited 22× · PMID 36474562 · DOI 10.1016/j.ocarto.2020.100033
8. The Current Status of Clinical Trials on Biologics for Cartilage Repair and Osteoarthritis Treatment: An Analysis of ClinicalTrials.gov Data.
   Zhang Z, Schon L. · · 2022 · cited 21× · PMID 35546280 · DOI 10.1177/19476035221093065