Part 4: Bangkok Conference on Stem Cell Therapy for the Failing Heart

MERRY CHRISTMAS EVERYONE!
Thought I'd share with you how we've decorated the office for the season. After a short break yesterday and a hearty dinner, I'm back to the blog...

Let's plunge right into it, the review of the last talk by a Tv representative. The CEO of Tv, Dr. Valentin Fulga didn't give away too much of the company's information or much on himself, except to review the cases done to date and also that he had some experience with the FDA and planned on getting approvals relatively soon. Much of the information he had was already mentioned in other talks and he used his time to credit them for their participation and active work.

THE QUESTION

I promised an answer to DTR's question and essentially I did pose this question at the very end of the symposium to Dr. Valentin Fulga, the CEO of Tv. Firstly, I commended him on successfully having Tv's stem cell technology effectively marketed the treatment to 180 patients to date. Logistics and coordination in itself is a real feat (flying the patient to Bangkok, flying the cells to Israel and back to Bangkok- wouldn't like to know their costs..), not to mention marketing the concept to doctors, hospitals and the patients from all over America. I noted also that almost all the patients were treated in Thailand, and curiously, none in Israel. I asked him why was this not the case as most lab services are derived out of its own community's requirements initially and then to serve a greater regional need.

THE ANSWER

He sort of woffled on for a few minutes and basically said that they were in the process of doing so but didn't really answer my question. I tried to assist by asking if perhaps it was a political issue in Israel that prevented them from doing any clinical work there; and his answer to that was that if there was a political problem he certainly didn't know about it as he hadn't been there in the last 2 months. Essentially, as Dr. Itescu pointed out to me later, there may similarly be many questions and queries on the validity of the work by Tv posed by Israeli doctors which is why they've taken their work to wherever they can.

I also spoke briefly to the president of their company in Thailand and the Asian region, a young trendy thirtysomething who goes by the name of Jimmy, he eluded to a fairly complex ownership structure of subsidiary companies and I wasn't entirely sure how he ended up in this business.

Anyway, since the cells are autologous and the treatments don't seem to be more risky than standard heart bypass procedures, I wish them well in their business as they may set an interesting price and model to shape how people in the US perceive stem cell therapy... preferably, with a vacation in Amazing Thailand. :)


StemLife also offers stem cell harvesting, processing and therapeutic services with renown Malaysian doctors for patients with heart failure and ischemic heart disease. If you're interested to learn how your stem cells can help your failing heart, please feel free to call us at +603 2163 8800 during office hours or ask your doctor to contact us at info@stemlife.com.


ps. If you missed the other parts of the conference entries, click on the label for "conference"

Part 2: Bangkok Conference on Stem Cell Therapy for the Failing Heart

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.

Part 1: Bangkok Conference on Stem Cell Therapy for the Failing Heart

I returned from a heart conference in Bangkok last weekend organized jointly by the Bangkok Heart Hospital and a company providing stem cell therapeutic services in Thailand to American patients known as Theravitae.

There were several interesting presentations, from Thai doctors in academic institutions and also several renowned doctors who were also associated in some form with private enterprises. One of the companies presenting their work was BioHeart. The speaker Kristin Comella gave a talk on how it was their company's belief that Myoblasts (ie muscle stem cells, obtained from the thigh) were the way forward in treating heart disease.

They presented a lot of animal data, which look very convincing, except that the company was asked to stop their trials in the US after several of their patients required the surgical insertion of a pacemaker after the procedure. I admit that their theory sounds attractive, take 10 grams of muscle from the thigh (not that I would want a scar on my thigh), culture the cells and place it in the heart by way of an angioplasty or direct intra-myocardial injection.

Interestingly, Bioheart revealed that they are in the process of manufacturing a machine which separates stem cells from fat. I stood up to ask if it was the same as what Cytori Therapeutics offers and Ms. Comella said YES. I suppose myoblasts from thighs are taking too long to get into commercial application and it would be easier to work with plastic surgeons instead.

I'll review a few other presentations in later entries of the blog as I'm a little tired tonight. Going to catch some sleep... zzz.

StemLife Blog Updates! Two Happy Stem Cell Patients

My apologies for the long hiatus! Its been very busy here at StemLife and I was reminded by colleagues that the StemLife blog was in need of my attention and that they were keen on knowing what news there was to share. The world of stem cell technology does not rest and whilst the recent events of war in the world have grabbed headline news, patients and stem cell followers have also had their fair share of updates.

In addition to the cord blood stem cell derived insulin secreting cell blog entry that I just published, I did see two other articles which I thought worthy of a mention.

ONE: Well done Dr. Suradej Hongeng in Thailand who has performed Thailand's first and most complicated triple stem cell (2 cord blood units + bone marrow from patient's mother) donor transplant for Thalassemia major. At only seven years old, the little boy who underwent the transplant at Ramathibodi hospital is already considered well enough after only 2 months in hospital. The cord blood units were only 80% matched with the patient's tissue type but the transplanted stem cells were well accepted and functioned after just 5 weeks post transplant.

In previous work, Ramathibodi had successfully treated 10 patients with blood disorders or cancers using cord blood stem cells from only one donor but has performed about 430 bone marrow transplants since the program commenced in 1989 according to Saengsuree Jootar. The limiting factors are almost rhetorical- high costs of the procedure ranging from Bt 300,000 to Bt 700,000 (approx. MYR 30K to 70K) and the well known challenges of finding a matching donor. The hospital does run a charity program of free transplants in honour of the Queen, in which 34 patients have already benefitted from the procedure.


TWO: Remember the Gary Schaer trial for heart that I keep mentioning? Well, in the last entry I asked how Rev. Eugene Carter was doing and I got my answer (it would be nice if he's decided to answer us because of the question posed in this blog!). He's doing just fine :)

EXCERPT:Last February, Carter needed his faith when he had a heart attack. He says, "I believe that anything that comes my way is there for a reason." So when doctors asked him to be in a study on stem cells just days after his heart attack, he said yes.

"The promise of stem cells is the promise that these cells could be given to grow new parts of the body that have been damaged," Gary Schaer, M.D., an interventional cardiologist at Rush University Medical Center in Chicago, tells Ivanhoe.

Dr. Schaer and colleagues are giving heart attack patients stem cells from a healthy adult donor. The cells are delivered through an IV. Once infused, they zero in on damaged heart muscle and repair it. Stem cells have shown great promise in fixing damaged heart muscle in pigs.

"I have been doing this for a little more than 20 years, and this is the most exciting new development in a very exciting field," Dr. Schaer says. Studies have shown using a patient's own stem cells can treat heart failure. He says using a donor's stem cells to treat heart attacks is a new frontier.

Carter feels lucky to be part of the study. "What an opportunity to do something positive," he says, and if the treatment helps, he'll have even more to preach about.


Excellent news. Okay, now back to StemLife work!