CellCoTec's Cellular Regeneration Technology (CRT) in cartilage regenerationFintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioTrinity at Newbury, Berkshire in the United Kingdom. On this show I have Ian Paling, who is CEO of a company called CellCoTec , welcome to the show.
Ian Paling:
Thank you very much.
Fintan Walton:
CellCoTec , is a company that is based here in the UK, it's got research and development facilities in Holland, tell us a bit about CellCoTec in particular its novel approach to cartilage regeneration?
Ian Paling:
Yes well CellCoTec was set up as a company to develop a unique solution to a problem that has existed for a long time which is the ability of the body to repair cartilage, because cartilage is a vascular there is no blood supply there it will not regenerate itself and therefore there is a need clearly to treat cartilage lesions with a technology that will allow that cartilage to regenerate itself and that was really where CellCoTec first started out with that concept and was built upon that.
Fintan Walton:
So in that respect what is unique about it? What's the basis of the technology?
Ian Paling:
Okay, well the technology incorporates several factors but in principle it's based upon a single surgical solution such as going to the surgery once rather than many of the competitive solutions which are in surgery twice it's autologous, it's cell based, it's also incorporates a biodegradable copolymer scaffold which acts as a support for the process. The process is mixing two cell types, what we do is we take a biopsy of the non-cartilage bearing part of the knee, sorry non-loaded part of the cartilage and we mix that with bone marrow taken from the iliac crest and the rationale and the (indiscernable) behind what we've done which we've proven in an animal model and in the laboratory is the two cell types when mixed together encourage the formation of cartilage chondrocytes and effectively to rebuild the cartilage within the patients need. It's a single surgical procedure and the purpose of taking these cell types and mixing them and seeding them on the scaffold is to allow early rehabilitation of the patient.
Fintan Walton:
So where is the patent intellectual property embedded?
Ian Paling:
Well the major patents been granted is a European patents which covers the mixing of the two cell types to form to reform cartilage. We also have a patent application which is awaiting grant which covers the isolation process of the chondrocytes from the harvested cartilage and the key to that is we've developed a technique using a series of enzymes for rapid isolation of the cartilage of the chondrocytes in the cartilage in typically in less than an hour which allows us to carry out this process within a single surgical technique.
Fintan Walton:
And in terms of the scaffold that you use is that is there anything unique about that or you just using standard?
Ian Paling:
Yes, let's say that's a copolymer PGT PVT scaffold it's been we purchased that from a company in Holland that was where our research facilities are as you say and we have exclusive rights to utilize that particular formulation, the actual manufacture of the scaffold is a 3D printing process as we do in-house. So there is a lot of knowhow attached to that, interestingly and importantly for us the material that's used for the scaffold has been used in 1000's of patients in the US as a cement (indiscernable) so it has a master file approved with the FDA.
Functions and practicalities of the technologyFintan Walton:
Okay, now the other thing just intriguing, when you create you put these cells together you started created cartilage for setting the basis for producing cartilage how does it control, you could end up in a situation where there is going to be too much cartilage produced so how do you, how can you define the physical structure of the cartilage itself in that consenting?
Ian Paling:
All the experimental work that we carried out both in vivo and in vitro and in a small animal model has indicated to us the typical percentages we need and the volumes we need in terms of number of cells to be able to create, to be able to fill specific defect sizes. So and actually our patent calls out a range of percentage of chondrocytes to bone marrow which we use at the bottom end so we know that a very small percentage of chondrocytes typically 1 to 2% of chondrocytes within that mix will create hyaline cartilage which is really what we're trying to do within a mouse model which is the small animal model we've used. What's very important in this technology there are lot of solutions, lots of people playing in this space in cartilage repair but what's hugely important is that we achieve a long-term solution to prevent degeneration into osteoarthritis and we are firmly of the believe that a cell based procedures is necessary, but be as important either we actually create hyaline cartilage which is the articular cartilage which is used in the body to allow motion but we create hyaline cartilage and not fibrous cartilage which is much more like cell tissue.
Fintan Walton:
So once the procedure is completed you know obviously the cells are working away to generate chondrocytes will allow the cartilage to develop, so how long is it take before a recovery is perceived by the patient?
Ian Paling:
Well let me explain the theory first of all then I will explain the practicalities. The theory is that the copolymer scaffold will degrade within 90% of that would degrade within 12 months in the same time the cells are working in harmony to recreate the cartilage. The scaffold provides that initial stability that's needed and it's a we call it a mechanically functional scaffold because it has very similar properties in that of makes of cartilage. In the clinical trial we are taking a fairly conservative view in terms of rehabilitation that's our anticipation that in the foremost of time we will be able to have patients back on full activity levels within 6 months.
CellCoTec is focused on knee joint marketFintan Walton:
Okay and obviously the application is for joints, which joints are you specifically targeting for these clinical trials?
Ian Paling:
Right, we are currently this is purely for the knee joint and it's we think there is a very large market opportunity out there, it's one of the unmet markets within orthopedic one of the early ones actually in my view. So and that's a very sizable market opportunity, we think there is a market opportunity of up to 4 or $5 billion per annum. So I am very keen that we focus it's a small company, it's a start up and we focus the company initially purely on satisfying this demand opportunity. We do believe that this can be broadened out in the future into other tissue types but right now we are very focused upon the knee market because that's where we will create value for the business.
Future partnership strategiesFintan Walton:
So what do you see you are obviously at the moment raising finance, you are looking to raise finance for your business you are going to take these things forward yourself to some level ultimately who do you see do you see CellCoTec being the company ultimately providing this as a standalone company or are you going to go out and look for partners and if so what sort of partner would rather take on a cell based therapy like this?
Ian Paling:
I think I've been around long enough to know that for a small company like this to go out and go through all the regulatory hurdles and the distribution hurdles on its own is in my view near impossible. So what we need to do is recognize what we good at and we good at inventing a technology and getting that through the clinical trial stage the European clinical trial stage. It's certainly our intention that we partner with one of the larger orthopedic companies who are involved in the reconstructive business currently and I think all of these companies recognize this is a space they need to be in, we will need a partner to help us through the US regulatory process, because to do that on our own would be very difficult and we will certainly need a partner to distribute the products both in USA and in Europe in the future. So again it's about recognizing where your strengths lie and then moving forward to partner with larger companies at the appropriate time. And the appropriate time for us will be once we've demonstrated the efficacy of the device through a clinical trial then I am sure we will start discussions with potential partners worldwide.
Clinical trialsFintan Walton:
So just going back to the clinical trials those are what have you actually got planned?
Ian Paling:
Right, we initially running a 10 patient clinical trial, which is in two centers one in Ghent in Belgium with a very well renowned surgeon Dr Verdonk and the other in the UK in Birmingham, The Royal Orthopaedic Hospital, Dr Snow. Both of those surgeons are very positive about the technology and Dr Verdonk has already implanted two patients with and has been very impressed by instrumentation and by the way the procedure has been carried out as I said currently it's a manual procedure but well in time be automated. So we've got another 8 patients to do then we will move to a larger 30 patient clinical trial and then eventually we will move to a trial in USA.
Fintan Walton:
And then you will be in a position partnering?
Ian Paling:
Well I think probably before than actually I think we will be able to demonstrate efficacy before the US clinical trial.
Fintan Walton:
Okay, excellent. Ian Paling, thank you very much indeed for coming on the show.
Ian Paling:
Thank you very much.