September 1, 2009 by

Horse Benefits From Adult Stem Cells

Continuing with an ongoing trend, and consistent with the latest developments in recent years, veterinary medicine remains several years ahead of human medicine in stem cell therapy.

As the latest development in veterinary medicine, Phil the horse has been treated with his own adult stem cells, derived from his own bone marrow just 2 weeks ago. Having suffered from a lame knee prior to receiving the therapy, Phil is now back to his usual self, unrestricted in motion and painfree. Increasingly, autologous (in which the donor and recipient are the same animal) adult stem cell therapy is being used in animals to treat a wide variety of ailments which include arthritis, tendonitis and even broken bones. Whether the condition is caused by an acute injury or by age-related degenerative conditions such as osteoarthritis, adult stem cell therapy continues to yield remarkable and consistent success in veterinary patients.

According to Martin Vidal, D.V.M., a veterinarian at the UC Davis Center for Equine Health, "The joint is a very delicate environment in horses. The horse has more appropriate mechanical demands than would be comparable to a human. The hope is that the stem cells will incite a reparative process." As Jeff Peck, D.V.M., a veterinarian at the Affiliated Veterinarian Specialists of Orlando, Florida, adds, "We know we’re not going to make those tissues normal, but it will suppress inflammation, slow the progression of degenerative changes in many cases, and also provide pain relief."

As previously reported a number of times on this website, companies such as Vet-Stem in the U.S. and VetCell in the U.K. have accumulated numerous documented cases of the benefits of autologous adult stem cell therapy in animals. To name just a few of the advantages, adult stem cell therapy yields faster healing and shorter recovery times than surgical treatments do, and adult stem cell therapy does not pose a risk of any side effects like medications do. Additionally, since the adult stem cells are autologous, there is no risk of immune injection. The U.K. company VetCell derives the autologous adult stem cells from the animal’s bone marrow, and to date has treated approximately 1,700 horses with an 80% success rate. By comparison, the U.S. company Vet-Stem derives the autologous adult stem cells from the animal’s adipose (fat) tissue, and to date has treated over 2,000 dogs and over 3,000 horses, also with an 80% success rate. With both companies, the procedure is quick, simple, and minimally invasive. Although the treatment is more expensive than conventional veterinary procedures, the adult stem cell treatment actually works, and noticeable improvement is seen almost immediately in all cases, not just in the 80% of cases that exhibit a complete recovery. By sharp contrast, however, conventional surgical and pharmacological therapies, which might initially be less expensive than stem cell therapy, only have a 30% success rate and therefore in the long-term are actually more expensive when repeated treatment is needed, or when improvements are not seen at all. Additionally, reinjury is significantly lower in animals who receive autologous adult stem cell therapy, due to the mechanism of action by which these stem cells activate the healing process. As Dr. David Mountford, a veterinary surgeon and chief operating officer at VetCell, explains, "After 3 years, the reinjury rate was much lower in stem-cell-treated animals: about 23% compared with the published average of 56%" for animals treated with conventional therapies. Furthermore, both VetCell and VetStem report a 100% safety rate. In other words, 80% of the animals treated are found to experience improvement in their condition with a reduction and often a full elimination of the need for medication, while adverse side effects have not been reported in any of the treated animals.

Not only do the stem cells automatically target the injured tissue, but they also stimulate other endogenous stem cells which in turn are mobilized into action and participate in the healing and repair process. Although improvements are usually dramatic and immediate, even after the first injection, additional injections may be necessary, depending upon the age and condition of the animal. Very few animals ever need more than a total or 2 or 3 treatments, however, before they are fully restored to their natural, pain-free state of mobility – which contrasts dramatically with conventional therapies such as most prescription medications which may need to be taken indefinitely, without ever producing any tangible signs of improvement and while even possibly causing further damage to the animal through dangerous side effects and other associated risks.

Ordinarily, injuries of the bones, joints, tendons and ligaments result in scarring of the tissue, which not only prevents full healing but also often leads to further injuries at a later time. Conventional medical therapies do nothing to address the problem of scar tissue directly, and surgical procedures actually make the problem worse by increasing the severity of tissue scarring which in turn merely exacerbates later complications that will inevitably result from the scar tissue, since such tissue can never be fully rehabilitated. Adult stem cell therapy, however, allows for the full and complete healing of tissue without scarring, which not only reduces the risk of re-injury of the same tissue at a later date but also restores full physical performance and function, usually very quickly and dramatically. Such is the case in humans as well as in animals. According to Dr. Robert Harman, veterinarian and founding CEO of Vet-Stem, "Our success in animals is directly translatable to humans, and we wish to share our evidence that stem cells are safe and effective." Additionally, adipose-derived stem cells have been shown in a number of studies to exhibit highly beneficial immunomodulatory properties – which reduce inflammation, among other benefits – in addition to stimulating the regeneration of cartilage and other tissue. (E.g., "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., published in the Journal of Translational Medicine in April of 2009, of which Dr. Harman is a coauthor). As Dr. Harman further adds, "In the last couple of years, evidence has come out that the cells we use reduce inflammation and pain, and help lubricate the joint. About 200,000 hip replacements are done every year in humans. That’s a very good target for someone to look at cell therapy."

Both Vet-Stem and VetCell use exclusively adult stem cells, derived from each animal’s own tissue. Since the cells are autologous (in which the donor and recipient are the same animal), there is no risk of immune rejection. More specifically, the stem cells that are harvested in these procedures are mesenchymal stem cells, which are highly potent adult stem cells that are found not only in bone marrow and adipose tissue but also in umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical and veterinary literature detailing the regenerative properties of mesenchymal stem cells.

No embryonic stem cells are ever used in either Vet-Stem’s or VetCell’s therapies, since embryonic stem cells are highly problematic in the laboratory, whether they are of human or non-human origin. Among other problems, the risk of teratoma (tumor) formation disqualifies embryonic stem cells for use as a clinical therapy, even in animals. Adult stem cells, however, do not pose such risks and are therefore rapidly accumulating a consistent history of successful clinical treatments in veterinary, as well as in human, medicine.

Of course, Phil the horse did not have to worry about an outdated federal regulatory agency preventing him from receiving his own adult stem cells as a therapy, unlike his human counterparts, at least in the United States. Until the U.S. FDA reverses its stance in which it insists that each person’s own adult stem cells must be categorized as a "drug", and therefore regulated as such, there’s not much hope of any human patient in the U.S. being allowed to receive autologous adult stem cell therapy, unless he or she is fortunate enough to be accepted into one of the very few FDA-approved clinical trials that are currently underway – and even then, half of all patients in each clinical trial will end up in the "control group", receiving a placebo instead of the adult stem cell therapy. It is precisely this politically motivated and scientifically erroneous stance by the FDA that is driving many U.S. adult stem cell companies, doctors and patients overseas where adult stem cell therapy is legally available. Fortunately, however, since the U.S. FDA does not govern veterinary medicine, U.S. animals are not forced to travel overseas for medical attention but instead are actually legally allowed to be treated with their own adult stem cells within the borders of the United States. With veterinary applications of adult stem cell therapies, in other words, there is no horsing around.

As Phil the horse would no doubt agree, it would seem as though the U.S. FDA lacks basic horse sense.

Filed Under: Adult Stem Cells, Multiple Sclerosis, News, Stem Cell Research, Uncategorized Tagged With: , , , , ,
September 1, 2009 by

Adult Stem Cells Applied to Cancer Therapy

The adult stem cell company Vitro Biopharma has announced pending patent applications on proprietary cell-based cancer therapies that are developed from human adult stem cells. Specifically, the therapies incorporate the natural properties of a specific type of adult stem cell known as mesenchymal stem cells (MSCs), a highly potent stem cell that is commonly found in bone marrow, adipose (fat) tissue and umbilical cord blood.

This new announcement for the use of MSCs in cell-based cancer therapies is believed to have wide-spread applications in the therapeutic treatment of certain types of cancer that are known to develop from a specialized set of cancer stem cells which are typically highly resistant to standard therapies such as chemotherapy and radiation. Among other forms of cancer, the glioblastoma tumors that are found in brain cancer would be an excellent candidate for treatment with Vitro’s new therapeutic approach. The novel cell-based therapies capitalize upon the natural tendency of MSCs to migrate to cancer stem cells, thereby utilizing the MSCs as a delivery mechanism to transport toxic agents that may selectively target and kill the cancer stem cells. Precisely toward such a goal, Vitro Biopharma currently has patent applications pending for their new proprietary adult stem cell therapies, for which the company is also actively pursuing strategic partnerships in the commercialization of these new therapeutic products. Vitro Biopharma currently has other related products that are already commercially available.

According to Dr. Pamela Rice, a member of Vitro’s scientific advisory board and an oncology researcher at the University of Colorado at Denver, "Cellular-mediated destruction of cancer stem cells represents a promising new avenue for the development of effective treatments that specifically target cancer stem cells. Vitro has developed an exciting portfolio of products to advance research in this field, which is one of the few approaches to show promise against intractable cancers such as most forms of brain cancer. Additionally, Vitro’s patent pending technology for cancer therapy represents an exciting and novel approach to the selective eradication of cancer stem cells that could usher in new promise in the fight against cancer."

Vitro Biopharma recently established a new manufacturing site in Golden, Colorado, comprised of both corporate as well as R&D facilities. Vitro’s commercial focus is on a series of products developed from MSCs and iPS (induced pluripotent stem) cells, as well as on cancer research that utilizes exclusively adult stem cells in the development of novel cancer therapies.

Filed Under: News, Uncategorized Tagged With:
August 31, 2009 by

Adult Stem Cell Company Reports on Heart Therapy

The Belgian adult stem cell company, Cardio3 BioSciences, today presented an update of its C-Cure adult stem cell therapy for heart failure at the 10th annual conference of the European Society of Cardiology in Barcelona.

Described as a second generation adult stem cell therapy, C-Cure allows the differentiation of a patient’s own (autologous) adult stem cells into "cardiopoietic" cells which then differentiate into new cardiac tissue, thereby repairing heart muscle. The proprietary product is derived from autologous adult stem cells that are harvested from each patient’s own bone marrow and cultured with a patented laboratory technology that yields the new, regenerative cardiopoietic cells. Currently C-Cure is being evaluated for both safety and efficacy in the treatment of heart failure in a double-blind, placebo controlled, randomized, multi-center clinical trial.

The international congress is featuring a number of recent advances in cardiac regenerative therapies, with particular emphasis given to the progress that has been made from first-generation to second-generation products. According to Dr. Christian Homsy, CEO of Cardio3 BioSciences, "The potential of cell therapies for the treatment of heart failure has long been recognized but there have been considerable hurdles to overcome in delivering on the promise. Today’s expert panel was able to provide a thorough review of the advancements in science that have brought about today’s second-generation cell therapies, and to put our product, C-Cure, into context. We believe C-Cure has tremendous potential to realize the promise of regenerative therapies in heart failure, and we look forward to the results of our pivotal trial."

Headquartered in Mont-Saint-Guibert, Belgium and founded in 2007, Cardio3 Biosciences, S.A., describes itself as focusing on "the field of regenerative therapies for the treatment of heart failure." As further described on the company’s website, "C-Cure is a cell therapy based on the usage of autologous stem cells differentiated into cardiac precursors called cardiopoietic cells. This second-generation cell therapy was developed based on research conducted with the Cardiovascular Center of Aalst, Belgium, and the Mayo Clinic of Rochester, Minnesota, USA."

Filed Under: Heart Failure, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
August 31, 2009 by

Skin Cells are Reprogrammed to Produce Insulin

Using ordinary skin cells derived from patients with Type I diabetes, scientists were able to reprogram the cells to create new cells that produce insulin. The announcement heralds a potentially revolutionary type of therapy for the millions of people who suffer from Type I diabetes.

In a procedure which is now commonly reproduced by stem cell scientists around the world, the researchers de-differentiated ordinary somatic (non-stem-cell) skin cells into a more primitive state, known as iPS (induced pluripotent stem) cells. In a new variaton on the theme, however, the iPS cells were then reprogrammed and re-differentiated into a new type of cell, one which resembles the insulin-producing beta islet cells of the pancreas. Specifically, the skin samples were obtained from two white males, one of whom had been diagnosed with Type I diabetes at 3 years of age, and the other of whom was first diagnosed at 21 years of age. Led by Dr. Douglas Melton, codirector of the Harvard Stem Cell Institute and a leading investigator at the Howard Hughes Medical Institute, the team of researchers reprogrammed the fibroblasts into iPS cells using 3 of the 4 genes that are commonly used for the iPS reprogramming procedure. Although the new cells do not produce insulin as efficiently as naturally occurring pancreatic cells do, nevertheless the new cells are responsive to changes in blood sugar levels. The procedure signifies an especially important accomplishment since the skin cells were not randomly taken from any donor but instead were specifically taken from patients who are suffering from Type I diabetes, thereby yielding a new type of cell which is "patient-specific" and which therefore matches the individual’s unique genetic profile, in addition to being free of any risk of immune rejection.

The next step now is to create an animal model of Type I diabetes in which the new cells can be studied. Eventually, the ultimate goal is to develop a clinical therapy from the procedure which can be used in human patients to replace the pancreatic beta islet cells that are destroyed by Type I diabetes.

According to Susan Solomon, J.D., CEO of the New York Stem Cell Foundation, which cofunded the study, "This is a big deal. Tackling the basic biology of Type 1 diabetes, which is a very complex disease, is a critical step. With these cells, we can see in a dish what’s happening to the immune system, and if you don’t understand the immune response, you get nowhere with Type 1 diabetes." As Dr. Meri Firpo of the Stem Cell Institute at the University of Minnesota further adds, "This is very preliminary data, but now we could potentially look at the interaction between immune system cells and insulin-producing cells to find the root cause or trigger, which we think might vary from patient to patient."

Meanwhile, however, such a therapy is still in the developmental stage, and the new insulin-producing cells are currently disqualified from clinical use since the genetic manipulation that is used for reprogramming the cells poses too many medical risks. Among other problems, cells from mice that have been reprogrammed according to this method have been found to develop into teratomas (tumors) when the cells were readministered to the mice. According to Julia Greenstein of the Juvenile Diabetes Research Foundation (JDRF), the most immediate applications of Dr. Melton’s new achievement "are primarily research-related". As she further explains, "Our hope is that understanding all of these things will come together – that once we’ve figured out how to make the cell source, we will have also figured out how to block the immune response, but there’s a lot of basic science one has to do to get there." Nevertheless, "There’s an incredible amount of exciting research that has the capacity to impact the disease in the long-term," she adds.

Believed to be of autoimmune origin, Type I diabetes destroys the insulin-producing beta islet cells of the pancreas. Though not as common as Type II diabetes, Type I diabetes is currently untreatable by conventional medical therapies, which offer no known cure for the disease. Since there is a strong genetic susceptibility, researchers believe that "patient-specific" therapies which are derived from each patient’s own unique cells should offer the most efficacious type of treatment. Such therapies would also eliminate any need for dangerous immunosuppressive drugs – if or when such therapies are ever actually developed from iPS cells, some day, at some undetermined point in the future.

Of course, "patient-specific" therapies already exist, today, and have already been derived from autologous adult stem cells and are already being used in clinics around the world for a wide variety of diseases and injuries, without any risk of immune rejection and without any need for dangerous immunosuppression – should anyone be interested to notice.

Filed Under: News, Uncategorized Tagged With:
August 31, 2009 by

The End of Hip Replacements

In the latest development of adult stem cell technology, doctors in England are pioneering a new technique in which autologous adult stem cells are used to repair damaged hips. The new procedure is already rendering conventional hip replacements unnecessary.

Having suffered from a painful weakening of his hip joint that was caused by avascular necrosis of the femural head (dead tissue in his leg bone at the hip joint), 39-year old Mark Venables became one of the first patients to undergo the new therapy, which was conducted at Spire Hospital in Southampton. Using adult stem cells that were harvested from bone marrow extracted from Mark’s pelvis, the doctors then mixed the stem cells with ground-up bone that had been derived from another patient. After removing the necrotic tissue from the ball of Mark’s hip, the doctors then filled the cavity with the new mixture.

As Dr. Doug Dunlop, who performed the procedure, explains, Mark’s bone eventually would have collapsed without the stem cell treatment. "If this new procedure works, he won’t need a hip replacement. It will fix his hip for life," according to Dr. Dunlop. As Mark himself stated prior to the operation, "I just want to get back to an active life." His rapid recovery would seem to indicate that he is on the road to doing exactly that.

Thus far 6 patients have received the treatment, 5 of whom have shown exceptionally rapid improvement. Although one of the 6 patients did not improve, no adverse side effects were reported in any of the patients. In the 5 of the 6 patients who did respond positively, improvement included the ability to walk normally again without any pain, and hip replacement surgery was no longer necessary. Prior to receiving the adult stem cell therapy, hip replacement surgery had been prescribed as necessary for all 6 of the patients.

Carl Millard, one of the patients who improved following the stem cell procedure, is now able to walk normally and without any pain. As he describes, "I feel great. If this can prevent people having to have a hip replacement, I think it’s wonderful."

Dr. Richard Oreffo of Southampton University has designed a further improvement upon the technique, in which an artificial material – containing all the right chemical growth factors for adult stem cells – would be used instead of donated, ground-up bone. As Dr. Oreffo explains, "Bone is a living vibrant tissue. These stem cells generate new tissue and drive new blood vessel formation to bring in nutrients. Just as people need cornflakes and sugar in the morning, so cells need nutrients to grow and survive – and that is what is so important here."

It has been estimated that approximately 30,000 knee replacements and 50,000 hip replacement operations are performed every year just in England and Wales alone. In larger countries, such as the U.S., the potential market is proportionately larger. By rendering conventional hip replacements obsolete, this new adult stem cell therapy promises to offer a highly preferable option to an increasing number of people who suffer from a wide variety of orthopedic problems. Indeed, as previously reported a number of times on this website, autologous adult stem cell therapy is transforming the entire field of orthopedic medicine, rendering most types of joint replacement surgery unnecessary. Such is the case not only for conditions of avascular necrosis, such as that featured herein, but also more generally for age-related osteoarthritis and degenerative joint diseases. No doubt the "orthopedic surgery" of the future will be vastly different from that of the past, and will most likely consist of pin-pointed injections of autologous adult stem cells rather than entire joint replacements.

Filed Under: News, Uncategorized Tagged With:
August 31, 2009 by

New Technology Launched in Stem Cell Preservation

The biotech company BioLife Solutions announced today the launch of its new biopreservation media product platform, known as BloodStor 55-5. The new technology offers significant improvements to the field of adult stem cell cryopreservation, and is expected to drive an increase in revenue at cord blood banks.

Already recognized as a leading manufacturer, developer and marketer in the field of biopreservation tools, BioLife Solutions is focused on the commercialization of novel ways to bank cells, tissue and organs. BloodStor 55-5, it’s newest product, is packaged in standard, single-use sterile vials of various volumes and is formulated with 55% USP grade DMSO and 5% USP grade dextran-40 in water for injection quality (WFI) water. BloodStor 55-5 also supports a common cord blood processing protocol.

According to Mike Rice, chairman and CEO of BioLife, "The launch of our BloodStor product family supports our mission to become the leading provider of preservation tools for cells, tissues, and organs. Specifically, our BloodStor product offering should enable BioLife to more quickly capture a larger share of the demand for preservation media products used in the rapidly growing cord blood banking industry. We’re leveraging our Quality System and the capacity of our recently validated internal manufacturing facility to offer more standard and custom products to our strategic markets. We’ve already received orders for BloodStor 55-5 and expect to begin customer shipments by the end of September."

The company expects to achieve the ISO13485 medical device quality management systems certification by the end of 2009. As described on their website, "All BloodStor products are tested for sterility to USP 71, endotoxin to USP 85, pH, appearance, and cell-based preservation efficacy."

As further described on the company’s website, "BioLife Solutions develops, manufactures and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs. The Company’s proprietary HypoThermosol and CryoStor platform of biopreservation media products are marketed to academic research institutions, hospitals, and commercial companies involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife’s GMP products are serum-free and protein-free, fully defined, and pre-formulated to reduce preservation-induced, delayed-onset cell damage and death. Comprehensive small animal intravenous safety studies have been completed on HypoThermosol and CryoStor, and both products are supported by US FDA Master Files. BioLife’s enabling technology provides research and clinical organizations significantly enhanced post-preservation cell and tissue viability and function."

BioLife Solutions will be presenting and exhibiting the BloodStor 55-5 at the AABB (American Association of Blood Banks) annual meeting and TXPO (for transfusion and cell therapy professionals), to be held on October 25-27 of 2009 in New Orleans.

Filed Under: News, Stem Cells, Uncategorized Tagged With:
August 31, 2009 by

BrainStorm Develops New ALS Therapy

The adult stem cell company BrainStorm Cell Therapeutics announced today that it has entered into an agreement with Protein Production Services, a leading manufacturing contractor, in order to begin production of its therapeutic adult stem cell product for the treatment of ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease). The production will commence in accordance with formal Good Manufacturing Practice (cGMP) production standards. Plans are also currently in development for use of the ALS product in a pre-clinical safety trial in which the product will be tested as a therapy in the animal model of ALS.

According to Rami Efrati, CEO of BrainStorm Cell Therapeutics, "We are very excited that we are moving into this phase of product development with a highly-experienced contractor that will enable us to move rapidly ahead with the final stages of our ALS pre-clinical program. As we announced on August 24 after securing new funding, BrainStorm now has both the financing and the production capabilities to achieve our goal of reaching human clinical studies in the coming year."

BrainStorm already boasts a portfolio of several patented, proprietary adult stem cell technologies, all of which are derived from autologous (in which the donor and recipient are the same person) adult stem cells harvested from bone marrow. Several of these products have already been successfully tested on various animal models of neurodegenerative diseases, with a number of the neuro-protective and neuro-regenerative properties of these products having been described in detail in more than a dozen peer-reviewed scientific publications.

As explained on the company’s website, BrainStorm Cell Therapeutics Inc. describes itself as "an emerging company developing adult stem cell therapeutic products, derived from autologous bone marrow cells, for the treatment of neurodegenerative diseases. The patent-pending technology is based on discoveries made by the scientific team led by Professor Eldad Melamed, former Head of Neurology at Rabin Medical Center, and cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The Company’s current focus is on ALS and Parkinson’s, although its technology has promise for treating several other diseases including MS, Huntington’s disease and stroke."

Established in 2005, Protein Production Services (PPS) describes itself as "an Israeli CRO/CMO for process development, production and purification of recombinant proteins" which "operates as a one-stop-shop for its customers, from cloning to cGMP production for phase I/II clinical trials, and has the capacity to produce in bacteria and mammalian cells." Additionally, PPS is developing its own platform of products known as "Biosimilar Plus".

Filed Under: News, Stem Cells, Uncategorized Tagged With:
August 30, 2009 by

Public Awareness of Cord Blood Opportunities Lagging

In an article entitled, "Lack of patient access limits promising cell therapy", a number of examples are cited in which a simple lack of public awareness about umbilical cord blood is the only thing standing between many patients and adult stem cell therapy.

Such awareness begins with the birth of a child, and whether or not the parents are even informed of their options for storing the child’s umbilical cord blood. Private cord blood banks charge a fee that can be as high as several thousand dollars, while public cord blood banks offer free storage. According to recent surveys, however, nine out of ten parents choose neither option, which means that the umbilical cords – along with all the highly potent adult stem cells that are contained within the cords – are discarded as medical waste. Even when a conscious choice is made to bank umbilical cord blood, many adult patients in hospitals around the nation who could benefit from the cord-blood-derived adult stem cells are unaware that such a possibility exists.

Known to be an extremely rich source of highly potent adult stem cells, umbilical cord blood has a long and carefully recorded history as it has been used for a wide variety of clinical applications for decades, safely and effectively. Additionally, such uses have been routinely reported in the medical literature for more than half a century, predating World War II, and also predating any clear scientific understanding of a human stem cell. With the more recent development of the modern concept of a stem cell, umbilical cord and placental blood are now recognized as excellent sources of adult stem cells that can be used in the treatment of a broad range of diseases and injuries. Furthermore, when one considers the number of births that occur daily, throughout the world, umbilical cord blood represents a virtually limitless supply of versatile adult stem cells which otherwise would simply be discarded as waste. Unfortunately, most of the time, this is exactly what happens.

In 2003, Ryan and Jenny Levine chose not to bank the cord blood of their newly born daughter, deciding that the cost was too high. When another daughter was born in 2006, however, they decided to bank her cord blood, paying the $2,000 fee for a private banking facility in Tucson. When the second daughter was diagnosed a year later with cerebral palsy, she was able to receive stem cell therapy from her own cord blood stem cells.

As an infant the child would only reach for her bottle and toys with her left hand, while her right hand remained clenched to her chest in a fist. Likewise, instead of crawling, the child could only scoot along the floor, with her right leg dragging behind her. Her cerebral palsy was suspected of being caused by an in-utero stroke, which could have left the child crippled for life. Instead, when the child was treated with her own adult stem cells derived from her own umbilical cord blood, she began improving within days. Within two weeks, the stiffness on her right side that had been evident since birth was no longer detectable. She was reinfused a second time with her own stem cells in May of 2008. Today, she is able to catch a ball with both hands, and she uses all four limbs to ride a tricycle. The autologous (in which the donor and recipient are the same person) adult stem cell therapy was performed as part of an FDA-approved clinical trial conducted at Duke University in North Carolina. According to the child’s mother, Jenny, "I tell anyone and everyone who is expecting a child that this is something that they need to at least consider."

Similarly, when Al Copeland of Phoenix was suffering from leukemia in 2007, he faced certain death within days after the bone marrow transplant that he had been awaiting fell through. Although he had never heard of cord-blood-derived adult stem cells, his physicians turned to a public cord blood bank in order to obtain the regenerative cells that saved his life. According to his physician, Dr. Jeff Schriber, who is also medical director of the Banner’s Blood and Marrow Transplant Program, "He didn’t have much time. Fortunately, we were able to get the cord blood quickly." Now that Mr. Copeland has been cancer-free for 18 months, he is a regular, voluntary visitor at Banner’s oncology unit, where he visits and encourages transplant patients, offering a sympathetic ear to their fears and concerns. As Mr. Copeland puts it, "If a poor kid from south Texas can do this, so can you. It’s going to be hard. It’s going to be a struggle. But you can pull it off, man. You can." As 57-year-old Graig Stones listens attentively, Mr. Copeland explains that the stem cells saved his life, adding, "It made me realize there’s a lot more to living than just getting up in the morning, putting on your shoes and socks and going to work each day."

Adult stem cells from umbilical cord blood have already been used to treat more than 70 illnesses over the past two decades, though most people are unaware of such facts. According to the National Marrow Donor Program, the number of units stored in their public network of cord-blood banks, which is now at 150,000, has more than tripled over the past five years, although this represents only 3% of the 4 million births that occur annually in the United States.

In addition to a severe lack of public education on the topic, experts cite two main obstacles that limit the availability of cord-blood stem cells, namely, cost, and an inadequate number of collection sites. The private Cord Blood Registry, based in San Bruno, California, for example, charges a $2,000 collection fee in addition to an annual $125 storage fee, though this guarantees the customer direct and exclusive access to his or her individual adult stem cells throughout the future, whenever necessary. Public cord blood banks, by contrast, allow neither direct nor exclusive accessibility to one’s donated cord blood stem cells, though donation is free, and the stem cells are made available to anyone in the general public who may need adult stem cell treatment. At the time of this writing there are currently only 19 public cord blood banks throughout the U.S., most of which have agreements with hospitals on the east and west coasts but nowhere in between; consequently, availability of their services is virtually nonexistent in other parts of the country. Additionally, the cumbersome amount of paperwork that is required for donation to a public bank is often a strong disincentive for many parents. Among other things, expectant mothers must submit a complete medical history prior to the third trimester of pregnancy and make their own arrangements for mailing the cord blood to the storage facility immediately after birth. Clearly, a donation process such as this would be more efficacious if it were simplified. According to Dr. Jordan Perlow, "Every day I have patients who say, if there’s an easy way I could donate, I’d love to do it," but an easy way does not yet exist. Although in recent years the U.S. federal government has initiated programs to increase public awareness of cord blood banking, in actuality the accessibility of such banking services still lags behind expectations. Since only 17 states have passed legislation requiring expectant mothers to be informed of cord blood preservation options, most new parents are still unaware that such possibilities even exist.

Advocates of public cord blood banking point out that the services have already saved numerous lives, even though the system is far from perfect. The highly potent mesenchymal stem cells that are found in cord blood are "immune privileged", meaning that they do not require an identical matching to the recipient, as bone marrow does, and therefore even one donated cord blood unit can potentially treat a large number of people, for a wide variety of illnesses and injuries.

In 2008, the National Marrow Donor Program, a Minnesota-based non-profit organization that handles requests for all publicly available cord blood, provided cord blood units for the treatment of nearly 900 people, signifying a 40% increase over 2007. Still, public cord blood banking remains significantly less popular than private banking, despite the difference in cost. New business models have been proposed for the public banking systems, which have set a goal of doubling their number of units, to 300,000, by 2015. Because the public banks bear the entire cost of the services, however, the question of funding is a serious one. By contrast, the Cord Blood Registry, which is the oldest and largest private cord blood bank in the world, already has over 270,000 cord blood samples in its inventory, which is 80% more than the number of samples in the "Be the Match" public-donor network. According to Tom Moore, CEO of the Cord Blood Registry, there has been a consistent 30% annual growth at the Registry over the past several years.

Nevertheless, private cord blood banks are increasingly attracting criticism for their exclusivity, as critics are increasingly encouraging a wider use of the more open services offered by public banking companies. In a policy statement issued in January of 2007 by the American Academy of Pediatrics, for example, it was estimated that the odds of any particular child actually needing to be treated with his or her own cord blood ranged from 1 in 1,000 to 1 in 200,000. There are therefore many physicians who agree with the Academy in urging greater use of public banks over private banks, since it is only the units stored in public banks which are made available to any patient anywhere who may be in need of adult stem cell treatment.

Umbilical cord blood has been documented in the peer-reviewed medical literature for its broad range of clinical therapeutic applications for over half a century, long before the concept of a stem cell became a topic of general interest. Today, a number of clinical trials are being conducted in which cord-blood-derived stem cells are being studied as a treatment for a wide variety of diseases and injuries, as these highly versatile adult stem cells are proving to hold greater, more concrete and more tangible therapeutic value than embryonic or iPS (induced pluripotent stem) cells, both of which are still in the experimental stages.

Unfortunately, neither the popular media nor, therefore, the general public, seem to be aware of such facts.

Filed Under: Cerebral Palsy, News, Stem Cell Research, Stem Cells, Uncategorized Tagged With: , , , ,
August 28, 2009 by

Vet-Stem Offers New Adult Stem Cell Culturing Process

The U.S. adult stem cell veterinary company Vet-Stem announces a new service which offers customers an endless, indefinite supply of autologous adult stem cells.

The new service, known as "Vet-Stem Culture", is the latest innovation in a series of novel applications of Vet-Stem’s proprietary stem cell technology. Often in the news for their highly successful therapies for dogs and horses, Vet-Stem is the leading veterinary stem cell company in the U.S. and the first to commercialize a highly efficient and efficacious adult stem cell therapy for veterinary use. According to Vet-Stem’s highly popular procedure, veterinarians collect approximately 2 tablespoons of adipose (fat) tissue from their equine or canine patients, which is then shipped to Vet-Stem’s laboratories where adult stem cells are harvested from the tissue, processed, and returned within 48 hours to the vet who injects the stem cells directly into the animal at the site of injury. The therapy continues to garner increasing attention for its consistently high success rate in regenerating diseased and damaged bones, cartilage, ligaments and muscle. Additionally, pain medications are usually reduced or eliminated altogether in animals who receive the Vet-Stem treatment, and previously prescribed surgeries often become unnecessary after the therapy is administered.

Now, Vet-Stem’s new "Vet-Stem Culture" constitutes a method for re-culturing the same sample of adult stem cells indefinitely, thereby providing customers with an "everlasting" supply of stem cells, without the need to surgically collect more. Whenever a sample is sent to Vet-Stem for stem cell collection, the customer is given the option of having a small subsample stored for future culturing, should the need ever arise, for which a nominal annual fee which is charged which is less than the cost of additional surgical collection procedures.

As Vet-Stem founding CEO Dr. Robert Harman describes, "The Vet-Stem Culture service is a breakthrough in veterinary medicine, finally allowing pet owners to take preventative measures towards the future health of their pets. This option is going to eliminate the need for these injured and arthritic animals to go through multiple surgeries to extract stem cells. Even more, the results we see in animals treated with fat-derived stem cells are exceeding our expectations. Now they can continue to be treated naturally, with their own cells, to feel young over and over again."

This is not the first time that Vet-Stem has revolutionized veterinary medicine. From a July 2009 survey which Vet-Stem conducted, it was found that, of all the animals who received Vet-Stem’s autologous adult stem cell therapy, "62% of dogs with arthritis discontinued or decreased use of non steroidal anti-inflammatory drugs (NSAIDs)." Additionally, according to the results of the survey, "Further feedback from veterinarians and owners indicated that more than 75% of dogs with arthritis have improved quality of life after their treatment." Side effects from NSAIDS, especially gastrointestinal complications, remain a common and significant problem for animals, many of whom cannot tolerate NSAIDS precisely because of such adverse reactions. Vet-Stem’s autologous (in which the donor and recipient are the same animal) adult stem cell therapy has offered an excellent therapeutic alternative for such animals.

A regular feature on this website, Vet-Stem continues to pioneer new laboratory and clinical technology in the veterinary stem cell field, all of which has applications that are directly translatable to human medicine. No doubt it is just a matter of time before such technology is applied to the long-term culturing of human adult stem cells.

Veterinarians who wish to learn how to administer the adult stem cell therapy must first become certified by Vet-Stem, which also offers accredited RACE (Registry of Approved Continuing Education) classes.

Filed Under: News, Stem Cells, Uncategorized Tagged With:
August 28, 2009 by

Cells Reprogrammed With Single Gene

Researchers at the Max Planck Institute for Molecular Biomedicine in Munster, Germany have simplified the method for generating iPS (induced pluripotent stem) cells from ordinary cells. Specifically, they have reduced the number of required reprogramming genes from four to one. The success of the new procedure, however, is heavily dependent upon the types of cells that are chosen to be reprogrammed.

Led by Dr. Hans Scholer, the team of scientists created iPS cells by reprogramming ordinary somatic (non-stem-cell) neural cells that were derived from aborted human fetal tissue. Clearly, the practicality of applying such a procedure to actual clinical therapies is quite low, due to the fact that brain biopsies are not easily obtainable from living subjects, and most countries have laws restricing the use of fetal and embryonic tissue. At least hypothetically, therefore, Dr. Scholer and his colleagues have proposed that neural cells derived from dental pulp might ultimately yield clinical applications.

Nevertheless, the choice of neural cells was critical to the success of the new procedure, since neural cells already express three of the four factors required for reprogramming into iPS cells, namely, Sox2, KLF4, and c-myc. Only the fourth factor, Oct4, is not naturally expressed and is therefore still required for administration to the cells. Although Oct4 was delivered via the conventional use of viral vectors, it was done without genetic integration, thereby yielding a final iPS cell which does not pose as many dangers and risks to potential patients as do those iPS cells that were reprogrammed from 4 genes.

The ultimate point of generating iPS cells is to create patient-specific stem cell lines which might then be utilized for the development of patient-specific therapies for the treatment of diseases that are unique to the individual patient. Of course, the creation of patient-specific stem cell lines has already been available with adult stem cells, and patient-specific therapies already exist from autologous (in which the donor and recipient are the same person) adult stem cells. Furthermore, with the "immune privileged", "universal donor" adult stem cells such as mesenchymal stem cells, patient-specific therapies are unnecessary since even allogeneic (in which the donor and recipient are not the same person) therapies have already been developed from adult stem cells. Adult stem cells, of course, are not nearly as "sexy" as embryonic stem cells nor even iPS cells, and therapies which already exist do not hold nearly the same irresistible fascination and "mystique" as do potential therapies which have not even been developed yet. Consequently, most of the media focus is on embryonic or iPS cells, not adult stem cells.

Last year, Dr. Scholer and his colleagues had succeeded in reducing the required number of reprogramming genes from 4 to 2. Prior to this latest achievement in which only one reprogramming gene is required, previous animal studies had indicated that the origin of the tissue plays an important role in determining differentiatability. In particular, cells derived from the stomach and the liver were found in mouse studies to be the most easily reprogrammable into iPS cells, but attaining stomach and liver biopsies from living human patients is also not always practical.

The 4 genes that have been conventionally used in the past to create iPS cells are precisely the same agents that render the iPS cells ineligible for clinical use, since the genes – one of which is an oncogene (which causes cancer) – introduce serious medical risks to the cells. Among other properties, the transcription factor Sox2 (sex-determining region Y) is essential for the undifferentiated self-renewal of embryonic stem cells, as is the protein and transcription factor Oct-4 (Octamer-4), a delicate balance of which is necessary for determining whether pluripotent cells differentiate or remain undifferentiated. A member of the Kruppel-like family of transcription factors, KLF4 is also simultaneously a gene and an antibody which plays a key role in cell proliferation and has been extensively studied for its role in cancer. Perhaps of greatest concern, however, is the proto-oncogene cMyc, mutations and overexpression of which have been implicated in many types of cancers. That fact that neural cells naturally express all of these factors except OCT4 is no doubt a topic of widespread research interest with applications in oncology and other fields beyond the immediate realm of neurology.

As Dr. Boris Greber, a member of Scholer’s team, explains, "Remarkably, it turns out that three of these four essential factors are already expressed in human neural stem cells, although not in skin cells, so we only needed to add one factor, OCT4. Ideally, we will be able to find a chemical that does the same job of expressing the factor without the need for a gene." Earlier this year, in fact, scientists in California announced the successful creation of iPS cells from mouse fibroblasts that were reprogrammed with a "cocktail" of proteins instead of the ordinary four genes, although this process is overall much less efficient. As Dr. Greber explains, "Without stable intervention using viruses, the frequency of reprogramming goes down and you have to wait a long time. We don’t have the perfect method yet." Nevertheless, as Dr. Greber further adds, in addition to being easier to reprogram, cells from neural tissue are also less prone to mutations than are cells from the skin.

Induced pluripotent stem (iPS) cells first burst into the news in 2006 when Dr. Shinya Yamanaka of Kyoto University in Japan announced the creation of these cells from ordinary mouse fibroblasts, which was succeeded the following year by the creation of iPS cells from human fibroblasts. Since then, the procedure has been reproduced numerous times by scientists around the world, a number of whom have contributed significant improvements to the process. Nevertheless, it is still not yet known whether or not these artifically produced cells will perform in vivo in a manner similar to that of naturally occuring cells. Since none of the iPS cells that have been created thus far are safe enough for clinical use, the actual therapeutic efficacy of these cells as a medical treatment remains unknown.

Filed Under: News, Stem Cells, Uncategorized Tagged With:
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