NCT01225575

Prospective, Randomised, Open Label, Multicentre Phase II Clinical Trial to Investigate the Efficacy and Safety of the Treatment of Large Cartilage Knee Defects(4-10 cm²) With 3 Diff. Doses of the ACT Product co.Don Chondrosphere®

Completed Phase 2 Last updated 15 March 2018

What this trial tests

Phase 2 trial testing co.don chondrosphere® in Large Articular Cartilage Lesions of the Femoral in 75 participants. Completed in 1 March 2018.

Timeline

1 October 2010

Primary endpoint
1 September 2013

1 March 2018

Quick facts

Lead sponsor	co.don AG
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	1 October 2010
Primary completion	1 September 2013
Estimated completion	1 March 2018
Sites	10 locations across Germany

Drugs / interventions tested

• co.don chondrosphere® — full drug profile →

Conditions studied

• Large Articular Cartilage Lesions of the Femoral — all drugs for Large Articular Cartilage Lesions of the Femoral →
• Condyle, Trochlea, Tibia or Retropatellar — all drugs for Condyle, Trochlea, Tibia or Retropatellar →

Sponsor

co.don AG — full company profile →

Who can join

Adults 18 to 50, any sex, with Large Articular Cartilage Lesions of the Femoral or Condyle, Trochlea, Tibia or Retropatellar. 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: 12 months after transplantation
  Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) from baseline (Day 0)to final assessment (FA)determined for each dosage group and between the dosage groups.

Sponsor's own description

This is a prospective, randomised, open label, multicentre Phase II clinical trial to investigate the efficacy and safety of the treatment of large defects with 3 different doses of the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) in subjects with cartilage defects of the knee.

After screening visit patients were booked for arthroscopy and had their cells harvesting from healthy cartilage. After the arthroscopy the patients were randomised in one of the three dose-groups. 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 of all dose groups subsequently followed the same rehabilitation program and had post-surgery visits. The 12-month-visit is defined as final assessment. Then patients have follow-up assessments up to 60 months.

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. The Effect of Cell Dose on the Early Magnetic Resonance Morphological Outcomes of Autologous Cell Implantation for Articular Cartilage Defects in the Knee: A Randomized Clinical Trial.
   Niemeyer P, Laute V, John T, Becher C, et al · · 2016 · cited 41× · PMID 27206690 · DOI 10.1177/0363546516646092
3. Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial.
   Becher C, Laute V, Fickert S, Zinser W, et al · · 2017 · cited 40× · PMID 28499391 · DOI 10.1186/s13018-017-0570-7
4. 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
5. 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
6. 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
7. Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.
   Kim J, Park J, Song SY, Kim E. · · 2022 · cited 14× · PMID 35582708 · DOI 10.1016/j.reth.2022.04.004
8. Safety and Efficacy of Matrix-Associated Autologous Chondrocyte Implantation With Spheroids for Patellofemoral or Tibiofemoral Defects: A 5-Year Follow-up of a Phase 2, Dose-Confirmation Trial.
   Hoburg A, Niemeyer P, Laute V, Zinser W, et al · · 2022 · cited 13× · PMID 35071653 · DOI 10.1177/23259671211053380