NCT00414700: TIGACT01

Prospective Multicenter Randomized Controlled Trial of ChondroCelect® (Via Autologous Chondrocyte Implantation) vs Microfracture (as Procedure) in the Repair of Symptomatic Cartilaginous Defects of the Femoral Condyles

Completed Phase 3 Results posted Last updated 22 September 2011

What this trial tests

Phase 3 trial testing ChondroCelect implantation in Articular Cartilage Lesion of the Femoral Condyle in 118 participants. Completed in 1 January 2010.

Timeline

1 February 2002

Primary endpoint
1 July 2006

1 January 2010

Quick facts

Lead sponsor	TiGenix n.v.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	118
Start date	1 February 2002
Primary completion	1 July 2006
Estimated completion	1 January 2010
Sites	12 locations across Belgium, Croatia, Germany, Netherlands

Drugs / interventions tested

• ChondroCelect implantation — full drug profile →
• Microfracture

Conditions studied

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

Sponsor

TiGenix n.v. — 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.

• Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining
  Time frame: 12 months post-surgery
  Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.
• Overall Histology Assessment on First Subscale of ICRS II Score
  Time frame: 12 months post-surgery
  Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)
• Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average)
  Time frame: Average change from baseline in Overall KOOS at 12-18 months post-surgery
  Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.

Sponsor's own description

This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect® in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible patients attended two screening visits and were booked for arthroscopy approximately 2 weeks later. At that time, patients were randomized to either ACI with ChondroCelect® or to MF, a procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue. Patients randomized to MF had the procedure performed at the time of their arthroscopy; those randomized to ACI with ChondroCelect® had their cells harvested during the arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee procedure, during which the ACI procedure using ChondroCelect® was performed. Patients subsequently followed the same rehabilitation program and had follow-up assessments up to 12 months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000 protocol. Subject to satisfying the eligibility criteria, patients who had participated in the initial 12 month trial could enter the extension trial. The 12-month visit for the initial study was the baseline visit for the extension study. During the extension study, patients have follow-up assessments up to 60 months post-surgery.

Publications & conference data

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

1. 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
2. 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
3. Barriers to Treg therapy in Europe: From production to regulation.
   Hennessy C, Deptula M, Hester J, Issa F. · · 2023 · cited 11× · PMID 36744143 · DOI 10.3389/fmed.2023.1090721