Latest news
November 2009 - CellCoTec cadavar knee trial
CellCoTec has recently completed a successful, independent human cadaver study of the company’s INSTRUCT scaffold fixation and associated surgical instrumentation products, as a precursor to the planned start of a first in human clinical trial. The study was conducted at the University of California, Irvine, at a leading orthopaedic centre.
The purpose of the trial was to evaluate the surgical instrumentation and fixation of the scaffold implant in a human cadaver knee. Dedicated instrumentation was used to create and prepare the defect site, to size the implant and to introduce the scaffold into the defect. Three evenly spaced sutures were used to fix the implanted scaffold.
The procedure was repeated using 2 scaffolds per site on 10 human cadaver knees and then subjected to 210 cycles, each of 1 minute duration, using a passive motion machine.
The trial results indicated that the instrumentation was both easy to use for the operating surgeon, and was able to accurately prepare the defect site in the articular femur. The instrumentation used to introduce the implant to the defect site was equally effective. Importantly, there was a 100% retention rate of the scaffold within the defect site, after completion of the passive motion cycles.
The positive results of the study support the company’s research to date, and give a solid basis for progression into the first human trials, which are due to commence very soon.
July 2009 - KEMA grants certification to CellCoTec
Dutch Notified Body, KEMA Quality, recently granted ISO 13485:2003 certification to CellCoTec.
The certification is a major step for CellCoTec toward achieving regulatory certification for its quality systems, which allows the company to move forward with confidence to its initial human clinical trial scheduled for late 2009.
Product Development Manager for CellCoTec, Jeanine Hendriks commented “ The outcome of the KEMA audit was very positive for us in that no major or minor non conformities were observed. As this was CellCoTec’s first major audit we are delighted that the team pulled together to achieve such a positive result”
July 3rd - CellCoTec joins forces with PA Consulting of Cambridge,
CellCoTec has recently joined forces with PA Consulting of Cambridge, UK to develop a Cell Processor which will allow automation of CellCoTec’s current manual cell mixing process.
PA is one of Europe’s leading consultancy companies in the field of medical device design and was selected from a very strong short list of potential candidates, in both Europe and the USA. PA has already completed Phase 1 of the development programme, aimed at specifying the process and recommending options for automation. Phase 2 of the programme is scheduled to start towards the end of Q3, 2009.
Ian Paling, Chairman and CEO of CellCoTec, said “We met with several extremely capable consultancy firms who had extensive experience in this field of devices, but PA impressed us most with their expertise and hands on approach. The Cell Processor is a fundamental element of our commercialisation strategy and we are delighted with the work that PA has carried out to date.”
July 1st - CellCoTec appoints new Head of Regulatory and Clinical Affairs
CellCoTec is delighted to announce the appointment of Joel Guidoux as Head of Regulatory and Clinical Affairs, with effect from September 1, 2009. This is an important appointment for CellCoTec as Joel will be responsible for coordination of all clinical trials, and global regulatory activities.
Joel has a BSc in Biochemistry from Faculty des Sciences de Rennes, France and over ten years clinical research experience in the medical devices field. Since 2003 Joel has been Senior Clinical Project Manager for the Biosurgery Division of Genzyme France SAS. As well as extensive clinical research experience, in a very relevant field, Joel has been closely involved with both the FDA and European regulatory bodies. He brings to CellCoTec a wealth of experience and will be a very valuable addition to the team.