US Recall News: AXP AutoXpress Cord Blood and Sick Cow Meat

In this week alone, I've received two articles from friends and colleagues informing me on the latest in a string of bad news from the US.

The first article was about Thermogenesis recalling 7,000 of its latest disposable bags custom designed to be used with the automated AXP device, used to process cord blood for stem cell separation.


WHAT'S THE PROBLEM?

Thermogenesis apparently failed to perform a quality control procedure on every shipment of the Auto-Xpress units from the time that the product first went on the market in 2006 up until now. The CEO, Willaim Osgood, who joined after the product went on the market, launched the recall after an internal audit found the flaw which was against the federal laws.

The flaw was the failure to perform quality control test for pyrogens (substances which cause fever, including bacterial toxins), which was omitted from the company's operating procedures.

This is one of my concerns in using any new products, as mentioned in my previous blog entry. It's always a real worry when products have problems and the service provider has to explain it to the clients. This is one of the reasons why we're evaluating if moving from a time trusted method to technology 1.0 is something that our clients would accept. Admittedly, cord blood stem cell clients need to be made aware of these concerns too.


WHAT'S BEING DONE ABOUT IT?

The CEO has admitted that "it was a mistake" on Thermogenesis's part and is now working with customers to retroactively test the Auto-XPress units, while the US FDA recommends that any cord blood units already stored be labeled as such so that they will be able to trace any problems if the unit is required for transplant.


According to the article:
There is currently no way to test whether a frozen cord blood sample is contaminated, according to the FDA recall notice. ThermoGenesis is in the process of validating a way to test for contaminants after a sample has been thawed.


While the AutoXpress sales accounts for 25% of Thermogenesis's USD 5.5 million revenue (making it the fastest growing product in the 22 year old company's history), its not the first problem with the bags due to the false-negative results in the first round which delayed shipments. This has depressed the company's share price (NASDAQ:KOOL) down by 6% to USD 1.53.

The AutoXpress bags are manufactured at an outsourced facility in Pennsylvania and the bags are tested at another outsourced facility.

GE Healthcare's Amersham division in Sweden signed an exclusive 15-year distribution deal with Thermogenesis to supply the AutoXpress system worldwide last October.

THE THERMOGENESIS REVENUE STREAM

The bulk of Thermogenesis's AutoXpress sales is currently from Cord Blood Registry (CBR) which collects and processes the majority of cord blood units in the US, though financial arrangements between them and Thermogenesis are not disclosed. The New York Cord Blood Bank also utilizes Thermogenesis's AutoXpress and I wonder how many units were used in public collections since June last year.

Thermogenesis predicts that first year revenue should be about USD 4 million with USD 50 million in total. Based on this number, between CBR, NYCBB and a smattering of other users around the world, approximately 35,000 to 40,000 AutoXpress units would have already been used for cord blood stem cell storage.


WHAT PROMPTED THE 143 MILLION KG BEEF RECALL?

The second news article was the US Beef recall that was sent to me via email... if you havent' already seen the nasty video and would like to see what prompted the recall, you can watch it here.

Bioengineering like the movies: Stem Cell Capturing Gadget

I'd hate to sound as if I was brought up on an entertainment diet of Hollywood movies, but back in the 1970's to 80's there was a real revolution in cinematic production and audience interest that led to a cult following of the science fiction genre.

Film directors often take what's probable in science and stretch them to the limits of our imagination, engaging us to just reflect on not only how far we've come but also how much further we can aspire. This next entry is a tribute to the 1987 movie "Inner Space"*.




In a recent announcement, MIT's bioengineers have designed an implantable device that is capable of capturing pure samples of stem cells from the circulating blood. The device is described as "a length of plastic tubing coated with proteins" which has been experimentally implanted into the bloodstream of rats.

The more accurate medical description of this plastic tubing is known as a "shunt" and the method of implantation would most likely involve the severance and reconnection of a small but high through-flow blood vessel. The proteins -known as selectins- attract and trap specific cells with the right signals on the surface (imagine a sticky mat). The cell capture devices are developed by chemical engineers led by Associate Professor Michael King from the Biomedical Engineering department at the University of Rochester. The technical details will be described in the March edition of the British Journal of Hematology.

(personal note: Mr. B.C. this is for you.)


WHY IS THIS DEVICE IMPORTANT?


The medical impact of this device could weigh in for cancer patients who may need to use autologous (one's own) stem cells for their treatment. These cancer patients are treated with chemotherapy to reduce and eliminate as many of the malignant circulating cancer cells as possible from the bloodstream and bone marrow. The treating doctor will collect the patient's own stem cells during this period of remission when the cancer load is at its lowest.

The patient's own stem cells are stimulated using GCSF (read about it here) and the stem cells are harvested and stored in anticipation of the possibility that the cancer cells will multiply again, requiring another round of chemotherapy which may damage the existing healthy marrow further. The collected stem cells will be infused back to the patient to ensure that the patient has sufficient stem cells to repopulate and replenish the marrow, thereby restoring normal cell levels to the bloodstream.

To address the concern that perhaps cancer cells from the patient might also be collected in the same fraction as the healthy stem cells (impossible to distinguish during harvesting) this device could lend a hand to filter out the cancer cells inside or out of the patient's body, i.e. the cancer cells would travel around the bloodstream until they reach the shunt, where they would then be immobilized.

Note though, that the inventors have conceded that this device will not be able to collect enough stem cells for a transplant, therefore the customary stem cell collection procedures will still need to be performed.


SOME INTERESTING STATISTICS


According the A/Prof. King, the shunt placed in an non-GCSF induced rat in a 2 hour period enabled the capture of 3-4 times the number of usual stem cells obtained in normal circulating bloodstream (approx 1%). Hence the device is thought to attract and specifically retain a significantly higher number of stem cells.

This stem cell number could be significantly higher in patients who have been mobilized.


WHAT ELSE CAN IT DO?


Well, it is a concept device which will be as good as its selectin coating. A/Prof. King has already forecasted the use of the device in trapping specific cancer cells in the body to prevent metastatic spread and layering in proteins which could help steer cell development processes by differentiating them while passing through the shunt. (analogy: think sticky mats for dust, sticky mats for cockroaches, sticky mats for cat fur...all requiring different levels of stickiness for its target)



WHEN CAN I BUY IT?


The entrepreneurial A/Prof. King has already started a company by the name of CellTraffix and the anti-metastasis implants are set for animal trials later this year in collaboration with bioengineers Professor Jeffrey Karp and Robert Langer at Harvard and MIT who will develop stable selectin coatings that will last over months than days. Meanwhile, the CEO of CellTraffix, Tom Fitzgerald has already announced that the company's first product for researchers to capture stem cells or cancer cells for lab experimentation will be marketed by early 2009, with clinical testing of the anti-cancer coatings in 2010.


Read how a chance encounter between a bioengineer and a haematology clinician gave rise to this work and watch the cells being captured here (note that you will need a high speed broadband connection as the video files are rather large).


*Why does this remind me of the movie Inner Space I hear you ask... well the term cell capturing device often conjurs up the image of a little machine (like the exploration submersible the protaganist uses) to grab and hold onto cells in circulation :)

Your OWN or your FAMILY's are always the BEST!

Use your OWN or a SIBLING’S cord blood stem cells and achieve CURE or REMISSION!

Data from a retrospective review of blood disorder patients treated with stem cells from their own cord blood (autologous transplant) or from the cord blood of a sibling (allogeneic-related transplant), presented at the American Society for Blood and Marrow Treatment (ASBMT) annual meeting showed that the majority of the patients were cured or achieved remission from their disease. Moreover, low risk of transplant-related complications with genetically-Related cord blood stem cells was seen.

Dr. Jennifer Willert, senior attending transplant physician and clinical professor at Rady Children's Hospital, University of California - San Diego, and lead author of this study said that “we now have important insights into the ability of transplant physicians to achieve successful outcomes using an individual's own cord blood to treat an environmentally-triggered blood disease or cord blood from a family member to treat certain genetic blood disorders and inherited bone marrow failure syndromes (IBMFs). Furthermore, the use of genetically-related cord blood may reduce the rate of mortality as well as the risk of treatment-related complications".

The analysis examined transplant recipient data from 16 cases of nonmalignant blood disorders. Four of the patients were infused with their own cord blood stem cells to treat aplastic anemia, an acquired condition. Twelve patients were transplanted with cord blood stem cells of a sibling for a range of inherited conditions including, thalassemia, sickle cell anemia, Fanconi anemia and Hurler syndrome. The review showed that two-thirds of the patients (10) are either cured or in remission, including half of the patients treated with their own cord blood. Three patients died of complications unrelated to their cord blood transplant; one patient experienced a relapse; and the outcomes status of two patients is not known. All 16 cord blood collections were processed and cryo-preserved at Cord Blood Registry and were viable for transplant when requested. The average storage time prior to use was about 27 months; however, one child's collection was stored for nine and half years and used to successfully cure that child's aplastic anemia (autologous use)!

Advantages of Genetically-Related Cord Blood Use in Transplantation

According to previously published data, transplantation of genetically-related umbilical cord blood has demonstrated clinical advantages over bone marrow, peripheral blood and unrelated umbilical cord blood. Since cord blood stem cells are immunologically younger than other "adult" stem cell sources, they demonstrate more versatility and flexibility when used in transplantation. Stem cell transplants from genetically-related sources (those from an immediate family member) result in better treatment outcomes than transplants from an unrelated donor and are associated with less frequent and less severe graft-vs.-host disease, a complication that occurs when the donor cells attack different parts of the body. Cord blood is rapidly becoming a preferred stem cell source in transplant therapy (a standard treatment in children's BMT already), with more than 10,000 cord blood transplants performed worldwide to-date.

Dr Willert said: "This study is relevant to any expectant parent considering whether or not to privately bank cord blood stem cells, Individuals who have access to their own cord blood stem cells, as well as a sibling's, have the best chance of treating a blood disorder that develops."

It is really not much to talk about here; the study really speaks for itself! The final comments of one of the authors say it all. Little miracles are hidden in our OWN veins!

Juvenile Diabetes Research Foundation (JDRF)

The Juvenile Diabetes Research Foundation (JDRF) gets into the game of stem cells, ADULT Stem Cells, together with Plureon Corporation, a biotechnology company based in Winston-Salem, N.C. that focuses on developing therapeutic applications of stem cells. The project plans to use Plureon’s technology platform to isolate adult stem cells from a type 1 diabetes patient and re-program them to generate fully functional pancreatic beta-cells. The objective is to return the re-programmed insulin-producing cells back into the patient in an autologous manner, i.e., without the need for immunosuppressive agents normally required for organ transplantation – in this manner, the patient’s own transplanted cells will be capable of glucose-dependent insulin secretion and the restoration of normal blood sugar levels.

Those of you that come here regularly you may remember a previous post about "A unique human blood-derived cell population displaying high potential for producing insulin", meaning that Plureon will be looking closer on to those cells, isolating them and eventually giving them back to the same patient (autologous) to cure the dreaded disease. If JDRF puts half a million dollars over 2 years on this then something is in the making. In the meanwhile, keeping and storing your own PBSC at a young age is probably the way to go in order to fully exploit this new technique when it comes! As an Endocrinologist and a Diabetes specialist I feel that exciting times are about to unfold in front of us. The future is here!