On March 11, 2013 CellCoTec BV, the wholly owned NL based subsidiary of CellCoTec Ltd, achieved the CE mark for its bio-resorbable scaffold, used to support an implanted cell mixture for treatment of knee cartilage defects. The CE Marking of Conformity certificate was granted by DEKRA Certification B.V. for CellCoTec's Class III medical device, based upon submission of a detailed registration dossier. The company submitted clinical data emanating from a 40 patient, multi centre, European clinical trial.
Ian Paling, CEO, commented "This is a major milestone achieved for CellCoTec, allowing the marketing of our cartilage repair technology throughout Europe. The availability to orthopaedic surgeons of a cell based cartilage repair treatment, which can be carried out in a single surgery, we believe is a very important step forward. Our clinical trial results have shown that the CellCoTec cell loaded scaffold re-creates hyaline cartilage, therefore offering the potential for a long term solution for patients with articular cartilage defects."
CellCoTec have just completed a Clinical Study Investigator meeting in Warsaw, Poland attended by an international group of participating surgeons, scientists and physiotherapists.
CellCoTec has successfully completed enrolment of all 40 patients in the first human clinical trial evaluating safety and performance of its unique, patented INSTRUCT cartilage repair therapy. The clinical trial was completed by orthopaedic surgeons trained in the procedure, in conjunction with skilled CellCoTec technicians, across key hospitals in England, Belgium and Poland. The dedication and teamwork shown by all those involved in the clinical trial has been instrumental in the achievement of this important milestone for the company.
Ian Paling, Executive Chairman stated “I am delighted that we have now completed the implantation phase of this multi centre European clinical trial. We are very encouraged by the early clinical results on this difficult to treat, group of patients”.
CellCoTec has pioneered this novel single surgery cartilage repair technology, combining isolated primary chondrocytes with autologous bone marrow cells as aspirated, seeded onto a mechanically functional co-polymer scaffold.
For more information about the INSTRUCT clinical trial, please visit the clinicaltrials.gov website (reference NCT01041885).
CellCoTec is delighted to announce the appointment of Fergus MacLeod to the position of Sales and Marketing Director. Fergus is a highly experienced orthopaedic sales professional who has very relevant recent experience within the sports medicine field. Fergus worked for several years at Stryker, UK in senior marketing, sales and business management positions. His extensive worldwide network will prove invaluable to the company as we seek to begin the commercialisation of our cartilage repair therapy.
Ian Paling, Executive Chairman, commented “CellCoTec is now rapidly approaching the time when we forecast granting of the CE mark to our INSTRUCT cartilage repair device. In anticipation of receiving the CE Mark, it was important that we made a high level appointment of a sales and marketing professional to spearhead our commercial activities. Fergus is a very high calibre orthopaedic sales and marketing specialist and his appointment now competes the creation of the senior management team at CellCoTec, in preparation for the planned product launch of INSTRUCT in Q3 of this year. I am very pleased that Fergus has committed his future to CellCoTec.”
CellCoTec is delighted to announce the granting of three new patents which substantially strengthen the company's intellectual property portfolio, for the use of cellular interaction to treat articular cartilage lesions of the knee.
It is now well established that a cell based therapy is most likely to be the most appropriate solution for creation of repair hyaline cartilage, when treating articular, traumatic cartilage defects of the knee. CellCoTec's technology incorporates autologous cellular interaction to allow for the prospect of hyaline cartilage repair, thereby providing a long term efficacious solution for this indication.
CellCoTec's master patent, which describes the mixing of cells for re-creation of articular cartilage, was granted in Europe in 2008, and an equivalent grant has recently been made in the USA. A patent covering the same technology has also recently been granted in Australia.
One of the unique features of the company's cellular interaction technology has been the ability to rapidly isolate chondrocytes from autologous harvested cartilage, thus allowing the procedure to be carried out in a single surgery. This rapid isolation technology was described in a European patent submission and this too has been recently granted in Europe.
The grant of these patents represents another important milestone achieved by CellCoTec in its quest to develop a strongly protected, efficacious treatment for traumatic cartilage injury.
CellCoTec, the regenerative medicine company specialising in autologous knee cartilage repair, is pleased to announce the successful completion of the implantation phase of its pilot clinical trial. Ten patients have been treated using CellCoTec’s INSTRUCT procedure at the Royal Orthopaedic Hospital in Birmingham, UK, University Hospital in Ghent, Belgium and the Centre for Sports Medicine in Warsaw, Poland.
This pilot clinical trial was designed to demonstrate safety and appropriate defect filling, and the company is extremely encouraged by the initial clinical data. Use of biopsies and enhanced MRI techniques has demonstrated structural repair of the defect site, a very positive indicator to the future long term efficacy of INSTRUCT in re-generating hyaline cartilage in the knee
As a result of the very positive early clinical results, the company has now commenced a follow on thirty patient clinical trial, using the existing surgical centres, together with three new centres in Poland. It is the company’s intention to make a CE mark submission for INSTRUCT, based on the pilot clinical trial data.
Concurrent with the early clinical trial success, CellCoTec has also recently completed a further round of fund raising. In September 2011, CellCoTec raised £1.8 million through an equity financing, largely from its current shareholders.
Ian Paling, CEO, commented “We are extremely pleased to have completed, successfully, the implantation phase of the pilot clinical trial. The clinical results, at this early stage, give us considerable cause for optimism, and the necessary confidence to commence the follow on clinical trial. In our view, cartilage repair is an area of orthopaedic surgery that is currently not well satisfied, and we anticipate that our INSTRUCT treatment could well prove to be a significant breakthrough.
We are also very encouraged by our ability to complete a further financing round, thus giving the company a substantial cash runway to move into the second phase of the clinical trial.”
Ground breaking orthopaedic solutions company, CellCoTec, has launched a pilot clinical trial by successfully implanting its first patient with the company’s INSTRUCT device. The revolutionary device has been developed to treat articular cartilage defects – an area of orthopaedic surgery that is currently not well served by existing technologies. CellCoTec’s implant incorporates an autologous cellular mixture within a mechanically functional scaffold, in order to promote early patient rehabilitation and the growth of articular hyaline cartilage.
Renowned orthopaedic surgeon, Dr Peter Verdonk of Ghent University Hospital in Belgium, operated on a 28 year old sportsman who had a recent traumatic injury in his left knee. The cartilage defect was centred on the lateral femoral condyle and was measuring 1.54 cm in length prior to debridement.
Unlike autologous chondrocyte implantation (ACI), the current gold standard treatment for cartilage repair, the INSTRUCT procedure is carried out with a single surgical intervention. During the surgical procedure, harvested autologous bone marrow cells and chondrocytes were separated from their tissue and mixed, before being introduced into a bio-degradable, load bearing polymer scaffold. Dedicated instrumentation was used by Dr Verdonk to create and prepare the defect site, to size the implant and finally to introduce the cell loaded scaffold into the defect.
Dr Verdonk, who is the first surgeon in the world to perform this operation, said: "The surgical procedure was easy and straightforward. I believe this innovative process has some unique advantages which could really mean a breakthrough in cartilage regenerative surgery."
The CellCoTec team, led by Dr Jeanine Hendriks used a series of manual techniques to facilitate the cell isolation, controlled mixing and scaffold seeding. CellCoTec has already started work on the design of an automated cell processor, which will be used when the technology is commercialised.
Commenting on the success of the initial procedure Dr Hendriks said: “The entire surgical team was delighted with the ease of the procedure and with the accurate placement of the cell loaded scaffold in the prepared defect. We now await, with interest, the outcome of tests to determine efficacy”.
Additional patients for the clinical trial will be enrolled in both Belgium and in the UK.
CellCoTec are confident that its innovative single surgery cell-based therapy could become the treatment of choice for severe articular cartilage lesions.
Ian Paling, CEO, commented “A few years ago, CellCoTec set out to develop a single surgical procedure for treatment of cartilage lesions, using autologous cell interaction, and one which would consistently demonstrate hyaline cartilage formation. We carried out extensive laboratory studies and have developed this patented technique, INSTRUCT, as a result. The population we aim to treat is both young and active, and our intention has always been to provide a treatment option to allow these patients to restore their quality of life. We are delighted that we have now commenced our pilot clinical trial so successfully”
Orthopaedic company, CellCoTec has developed and manufactured a complete set of CE marked instrumentation to support the application of the company’s innovative INSTRUCT cartilage repair therapy.
The INSTRUCT Instrumentation has been developed in close collaboration with clinicians, the emphasis being on simplicity, accuracy and ease-of-use. The INSTRUCT Instrumentation kit comprises of a range of manually applied tools, used in the patient, to size the cartilage defect and, under guide pin control, demarcate the cartilage boundary and create the final shallow osteochondral implantation site.
Elements of the INSTRUCT Instrumentation are also used to support INSTRUCT cell and scaffold processing, and to accurately cut the INSTRUCT implant to fit the prepared implantation site. The instrumentation has been used for the first two patients who have been treated in the pilot clinical trial. The simplicity and ease-of-use has been praised by clinicians as a key factor for achieving reproducible results with the INSTRUCT instrumentation.
The INSTRUCT Instrumentation has now been CE marked, and is registered with the Dutch Ministry of Public Health, Welfare and Sport as a Class I medical device, in conformance with the Essential Requirements of the European Medical Device Directive.
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.
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”
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.”
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.