Thanks DTR, for prompting me to write another entry on the heart conference I attended in Bangkok. These next few entries will hopefully answer your questions, which are pretty much my own as well.
As the main sponsor of the conference, alongside Bangkok Heart Hospital, it was Theravitae's aim to showcase their technology and data to impress doctors from all over the world. Notably, the speeches were delivered by three company respresentatives. Namely Yael Porat (who is the chief scientist at Theravitae's lab in Israel), Dr. Valentin Fulga (CEO of Theravitae Ltd in Israel and Bangkok) and one of the founders by the name of Don Margolis.
Review of Theravitae talk by Yael Porat, Neiss Ziona, Israel
Yael Porat's talk was more "technically" based, giving some simple parameters by which they qualified their work. Essentially, they take a bag of blood (250 ml) from a potential heart patient, fly it over to Israel and leave it in Yael Porat's lab. In simple terms, she plates in out into cell culture flasks and lets the cells known as ACP's (angiogenic circulating progenitors) grow in the presence of growth factors such as EGF, VEGF, IGF and b-FGF. She stresses that no animal serum is used, only patient's autologous serum and some heparin (as an anti-coagulating factor).
After growing the cells several rounds in a GMP/ clean room type facility and achieving as much growth as they can without damaging the cell line, Yael resuspends the cells in medium (not sure what medium it is but it looks like serum), packages the cells in syringes and sends it to the hospital in sterile, bubble wrapped pouches and shhipped at 2-8 degrees Celsius. This final product is known as Vescell and is applied to the patient either via angioplasty or by direct intramyocardial injection.
She couldn't give much away in terms of information apart from showing how they labelled the cells and assuring the audience that the lab in Israel was par excellence. Her slides were mostly text based with just one picture of a biosafety cabinet in a clean room and the cells in syringes and a few staining images. The questions which followed her talk mostly pertained to the manipulation of the cells and its logistics. Manipulation* wise, it seemed like pretty standard cell culture techniques without much selection (although without further disclosure from them, I really wouldn't be able to confirm this) but in the US, FDA does not permit the use of any manipulated cells at this time.
QUESTIONS & ANSWERS
Dr. Doris Taylor asked about the logistics of the cells which have to travel from Bangkok to Israel and back, how would the cells be transported and how would they ensure quality without deterioration or even that they remained the same cells during the journey?
PACKAGING:
In a cooler bag with temperature logger throughout journey to ensure the cells are kept between 2-8 degrees C.
CELL IDENTIFICATION:
The answer that Yael gave was that Theravitae would check the cell numbers and their identity prior to shipment, but there would not be any necessary checking at the hospital when the cells arrive. (ie assumption that cells stay the same)
TRANSPORT:
Next flight out policy, and they have already checked how the cells in the collected blood (at the beginning) can still be viably used after 24 hours as Yael used to work on old/ expiring bags of blood obtained from the blood bank. As for bringing the cells back to the hospital, she says that the cells have to be packaged right and be shipped to the site within 24 hours by special courier.
Next was a question by Dr. Sujit Banyatpiyaphod, cardiac surgeon from Bangkok Heart Hospital. He asked if the cells could be frozen down? Reason being that some of the heart patients were in critical condition and if the patient needs to wait another 2-3 days after the cells arrive for the injection procedure, would the cells still be ok to use or can it be kept frozen for application at a later date.
Yael replied with a NO, the cells cannot currently be frozen down although they are trying to work on it. Right now, if the patient is unable to use the cells, then she would prefer if the doctor collected another round of blood and send it over to her again for culturing so that it is prepared fresh.
PRACTICAL & LIMITING CONSIDERATIONS
It seems to me that there are some practical considerations to this sort of cell therapy where time limitations and cell viability all play a sizeable role in the economic costs to patient, planning costs to the doctor and hospital. One thing Yael didn't volunteer, was whether this situation has arisen before and whether there is a company guarantee for another round due to unexpected circumstances.
Even if Theravitae builds a lab in Bangkok and shortens the logistics time, it is clear from this they will still need to overcome the issue of storage or of affordable 2nd time therapies. The way to understand this is to really understand cellular biology- cells are alive, metabolism keeps going and prolonged exposure to a different or manipulated environment has its own way of changing cellular fate. Obtaining fresh blood from the patient may not be difficult, but re-culturing them in time for the procedure (if its urgent) is a present challenge.
I'll be writing about what the CEO said in the next entry- and answering DTR's question posed in the last blog. :)
*Manipulation in this context means the alteration of the cells' environment, or selecting for certain cells in a mixture, or the addition of factors which may induce changes in the cell's composition or identity.
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