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Nostrils flaring, ears pricked, Solid Gold shifted nervously as the vet stroked his injured foreleg.

The three-year-old racehorse had no way of knowing this injection would save his career, not end it.

While debate rages over the ethics of stem cell research for humans, a Singapore-based firm has given Asian racehorse owners a new weapon in the battle against career-threatening tendon and ligament injuries.

After harvesting bone marrow from the horse’s sternum, EZ Stemcell separates multi-potential stem cells, which are then injected directly into the injured tendon.

This cutting-edge technology will not only revolutionise the way injured horses are treated, says Dr Omie Rangabashyam, but two-legged patients could one day be treated in a similar way.

“By injecting the stem cells directly into the core lesion, the tendon will regain its integrity, will regain its strength, without the fibrous scar tissue that forms with conventional treatment,” Rangabashyam, a director of EZ Stemcell, told Reuters as he tried to calm the horse.

“Without stem cell therapy, Solid Gold would have been rested for a year, raced again and the tendon would probably tear again.

“That would be the end of him.”

COOL CURED

Following a few days’ box rest, Solid Gold will undergo a programme of gentle walks and exercise to get the tendon working as normal. He should be doing solid work on the track in about seven months, said Rangabashyam.

The treatment has already been used in Britain to some success, with the Martin Pipe-trained Mr Cool receiving stem cell therapy after injuring a tendon in March 2004.

The hurdler returned to competitive racing a year later and went on to win on its second outing after the procedure.

EZ Stemcell had already been approached by owners throughout Asia and Australia and the firm was looking into the possibility of expanding into the lucrative Dubai racing scene.

For owners and trainers in Singapore, where the racing calendar peaks with the $3 million Singapore Airlines International Cup, counting the cost of injuries runs into millions of dollars.

Rangabashyam, who owns more than 30 horses stabled at the Singapore Turf Club, paid 500,000 Singapore dollars ($308,600) for a German horse that has since run just twice in 2 ¸ years because of a succession of injuries.

A stem cell shot costs 2,888 Singapore dollars.

Mark Clements was the first trainer in Singapore to have a horse treated with stem cells.

“The traditional way to treat a horse with a tendon problem was rest — throw it in the stable and forget about it for a year,” the Zimbabwe native told Reuters at the Turf Club.

“They were also injecting various drugs into the injury, which never really worked.

“They had limited success with injecting raw bone marrow but the results with stem cells are on a different level.

“No scar tissue means the tendon gets its elasticity back, which means the horse’s movement, and ultimately its speed, is virtually unaffected.”

ENDLESS POSSIBILITIES

The benefits of stem cell therapy may one day reach far beyond racing circles.

Doctors in Thailand have been using an experimental procedure to treat heart patients with adult stem cells harvested from their own blood, bypassing both the risk of rejection and the controversial subject of embryonic stem cell use.

Some people oppose the use of embryonic stem cells, saying a human life must be destroyed to grow the cells.

Companies in the United States are also exploring the commercial potential for stem cells as treatment for diseases such as diabetes.

Rangabashyam, a liver specialist at Singapore’s Gleneagles hospital, says the green light for using stem cells in the treatment of liver disease is not far off.

“Soon we’ll have it for acute liver disease, for acute renal disease. There’s trials going on in the U.S. for the treatment of neurological disease,” he added.

Another Singapore firm was storing umbilical cords of newborns so that they could perhaps one day be used to cure them of disease or injury.

“The physiology of all living things is the same. With stem cells, anything is possible.”

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Researchers at a Children’s Hospital in Oakland believe they have found a new source of stem cells that could cure a variety of blood diseases. The breakthrough would help not just children, but adults as well.

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Researchers took stem cells from the placentas of consenting women who had Ceasarian sections at Alta Bates Medical Center in Berkeley. Doctors found a large number of blood producing stem cells in those organs which they were able to grow.

Researchers say these cells don’t have to perfectly match the bone marrow of patients looking for transplants.

“The important thing is can you harvest them, are there plenty of them and can you use them? And that’s what we have shown,” said Dr. Frans Keypers.

Patients currently have to wait until a bone marrow donor match is found and if the tissue isn’t similar, the body will reject the transplanted marrow. With these placental stem cells, the match doesn’t have to be as precise, offering hope to African American, Asian and multiracial patients who often can’t find donor matches.

Before this, scientists were primarily studying embryonic stem cells which have the ability to grow into any kind of cell type. The findings appear in the next month’s issue of Experimental Biology and Medicine.

Image courtesy of Adam Inc

Stempeutics Research Pvt Ltd, a group company of Manipal Group, has achieved a major breakthrough in stem cell production technology with the manufacture of its Investigational New drug (IND) sourced from Mesenchymal Stem Cells (MSCs) derived from bone marrow of healthy donors. Using the IND, the company has commenced the placebo controlled double blind trials at Bangalore, Kochi, Hyderabad, Ahmedabad and New Delhi.

The company through its newly designed proprietary technology is able to achieve large scale expansion of MSCs at its cGMP compliant unit at Manipal near Mangalore. It can produce stem cell-based drugs for over 10,000 patients from a single healthy donor through the innovative technology. MSC has received considerable attention in biological research because of its self renewal capability and its ability to expand and trans-differentiate into many different cell lineages. In addition, MSCs are immune privileged and there are no ethical issues involved since it is derived from adult stem cells. To meet large scale bio-production and make the drug affordable, a fast MSCs expansion method was the need of the hour, BN Manohar, president, Stempeutics Research stated.

Having gathered information about the path breaking research and production efforts, Union minister for state science and technology, Prithviraj Chavan who was in Bangalore made a surprise call at the company to have a first hand comprehension of the development.

“Taking into consideration, the lack of a uniform approach for MSC culture and expansion, we designed a technology and manufacturing process by identifying an optimal culture media and the harvesting time. We also ensured an appropriate combination of cell culture containers – while maintaining its multi-lineage differentiation potential. Through this production research which has lasted for more than two years, Stempeutics has achieved its break through where by it can produce from a healthy voluntary donor, drugs required for more than 10,000 patients,” explained Manohar.

According to Dr Ranjan Pai, MD & CEO, Manipal Education & Medical Group, the global market for Stem Cell therapies estimated US$20 billion by 2010. Adult Stem Cell therapy currently dominates the global stem cells market with a share of almost 58 percent. The current stem cell therapy market in India is valued around US$540 million. While the opportunity is good it is essential that cost of stem cell treatment becomes less so that it is affordable by a common man. It is essential to come out with innovative production techniques for up scaling and make therapy affordable, he added.

Image courtesy of Healthwise, Incorporated

Researchers are suggesting that discarded fallopian tubes from hysterectomies could be a good source of donor stem cells — offering another “ethical” route to creating stem cell treatments without using embryos, BBC News reported.

Experts say they contain a rich source of the immature cells that have the potential to become a variety of the body’s tissues, like muscle and bone.

Previous studies have shown it is possible to get mesenchymal stem cells from umbilical cords, menstrual blood, teeth and fat tissue.

University of São Paulo researchers now believe that fallopian tubes, discarded during the course of hysterectomies or female sterilization operations, may also have an abundant source of these cells.

The scientists were able to harvest, multiply and then coax the mesenchymal stem cells to turn into healthy muscle, fat, cartilage and bone cell lines in the lab, according to the findings published in The Journal of Translational Medicine.

The team suggests these adult stem cells could also be useful for understanding and treating fertility problems since they are capable of replacing damaged cells in the fallopian tube.

While these cells could provide a source of stem cells for regenerative medicine, it will still take more time and research before they could be given to patients, the team noted.

Since stem cells from embryos are in a so-called pluripotent state, meaning they have an unlimited capacity to become any of the types of cells and tissue in the human body, most of the work on stem cells has focused on that type of research.

However, many religious groups and objectors argue it is unethical to destroy embryos in the name of science.

“This is another promising source to add to the list of so-called ‘ethical’ sources of stem cells,” said stem cell expert Stephen Minger of Kings College London.

But Minger noted that bone marrow and fat were more accessible and less intrusive sources for stem cells.

“Obtaining multi-potent stem cells from discarded fallopian tubes is yet another example of the extraordinary potential of human waste tissue,” said Josephine Quintavalle of Comment on Reproductive Ethics.

She hopes that these cells could also be used for infertility problems in women, as they could possibly repair damaged fallopian tubes for women who can’t conceive.

Amid the blast walls and cacophony of Baghdad, patients at a local clinic are receiving potentially groundbreaking stem cell therapy, treatments that remain illegal and unproven in many countries.

Dr. Abdul Majeed Alwan Hammadi is conducting the treatments for free, mostly on young Iraqis. He is a clinical hematologist who works in the Bone Marrow Transplant Center, part of Baghdad’s Medical City complex of hospitals on the eastern banks of the Tigris River.

Hammadi says he started therapies in 2008 and has so far treated 34 patients, the majority for multiple sclerosis.

Bagdad Iraq

Hammadi, who graduated from a medical college in Baghdad, claims no side effects have been reported in his patients. He said he is in the process of collecting his data for publication, while also seeking official license for the therapies from Iraq’s Ministry of Health, which funds the center.

One of Hammadi’s patients and proponents of the therapy is the Rev. Andrew White, a British priest who runs St. George Church on Baghdad’s Haifa Street.

White was diagnosed with multiple sclerosis in 1998 and said his vision, speech and motor skills were steadily degenerating until he began Hammadi’s therapy in January.

White helped Hammadi establish the bone marrow center in Baghdad in 2001, bringing the doctor and his staff to England for training in marrow transplant techniques.

White said his slurred speech and other MS symptoms improved since starting the three-hour therapy sessions, which involves Hammadi extracting adult stem cells from White’s blood and then injecting them into his spinal cord.

It is unknown why MS causes the body’s immune system to attack the protective coating around nerve fibers, known as myelin, which results in nerve damage and loss of motor functions. The condition’s severity varies, with some people improving on their own while others continue to degenerate.

The potential benefits of stem cell therapy for MS are still being analyzed and researched in the Western world, but White said he accepted Hammadi’s offer for treatment because his symptoms were so severe and he trusted his friend.

“When there’s no other treatment, you kind of just go with it,” White said. “At least there’s a chance.”

White said the therapy itself “can be a bit painful” since it involves a spinal cord puncture, but there has been a “massive difference” in his condition.

“It’s very rare for me to actually feel ill now,” he said. “My balance is still quite bad and my vision is not perfect, but I do not feel ill.”

MS doctors and researchers believe stem cell therapies could pose benefits for those suffering from the disease, but the research is still unproven at this point, according to Dr. Patricia O’Looney, vice president of biomedical research for the National Multiple Sclerosis Society’s research and clinical program department.

One theory is that a person’s adult stem cells can work to rebuild the myelin around nerve fibers that is eaten away by a person’s immune system under MS, halting any further damage.

Hammadi said he is the only doctor in Iraq performing such therapies, but that there are similar operations being performed in Iran and Lebanon.

At this point, the therapies aren’t proven, and any side effects from the treatments are unknown, O’Looney said. “We’re seeing a wide range of results [at the stem cell clinics], which tells us there might be a hint of benefit, but what we need to do of course is a larger study to really understand if stem cell therapy is beneficial,” she said, adding that because stem cell research is only about 10 years old, enough isn’t known yet about the cells. “We do discourage anyone with MS from going to these so-called stem cell clinics,” O’Looney said.

But for patients like White and others suffering from the disease, waiting for the research to come through can be too much to bear.

Part of some patients’ sense of urgency comes from the disease’s unpredictability. Sometimes the disease goes into remission on its own; sometimes a patient is in a wheelchair within 10 years of being diagnosed.

As a result, MS sufferers have sought out a variety of cures over the years, O’Looney said. “If you flash back 25 years ago before [current MS therapies], people were using snake venom or bee stings.”

Stem cell clinics based on untested science can also give false hope to those with MS, O’Looney said, and positive results like White’s could be due to a number of factors, from pre-existing therapy regimens to the body’s immune system correcting itself on its own. “Just because someone switched from tomato juice to orange juice in the morning and feels better doesn’t mean it’s the orange juice,” she said. “The body does have the capability to repair itself.”

But for some patients like White, hope is all there is when dealing with MS. No matter where the treatment takes place.

“In the midst of the war zone, I get such high-tech treatment,” he said. “I can go to Baghdad and get it.”

According to a new report in Fortune Magazine, marketable therapies emerging from work in the (less controversial) adult stem space could be the next multi-billion dollar market.

Research on adult stem cells has generated a great deal of excitement. Adult stem cells have already been used successfully with patients: to treat cartilage defects in children; restore vision to patients who were legally blind; relieve systemic lupus, multiple sclerosis, and rheumatoid arthritis; and to serve as an aid in numerous cancer treatments.

Scientists have found adult stem cells in many more tissues than they once thought possible. This finding has led researchers and clinicians to ask whether adult stem cells could be used for transplants. In fact, adult hematopoietic, or blood-forming, stem cells from bone marrow have been used in transplants for 40 years. Scientists now have evidence that stem cells exist in the brain and the heart. If the differentiation of adult stem cells can be controlled in the laboratory, these cells may become the basis of transplantation-based therapies. These Adult stem cells can be harvested from many areas of the body, including the bone marrow, fat and peripheral blood. Once the cells have been harvested, they are sent to the lab where they are purified and assessed for quality before being reintroduced back in the patient. Since the stem cells come from the patient there is no possibility for rejection and they are used in transplants to treat diseases, such as cancers like leukemia.

According to various studies, stem cells isolated from a patient (i.e. from the bone marrow or fat) have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells and cartilage cells). Studies have also shown that these are capable of “homing in” on and repairing damaged tissue. Researchers feel they are far closer to commercializing drugs based on adult stem cells than any product based on embryonic stem cells. In fact, many clinics outside of North America already tout stem cell based treatments to treat chronic diseases for which there are inadequate standard therapies. These clinics currently accept patients with Diabetes Type 2, Autoimmune Diseases, Multiple Sclerosis, Degenerative Joint Disease, Autoimmune Diseases as well as Rheumatoid Arthritis and Osteoarthritis. Unfortunately, patients seeking those treatments in other countries most often run the risk of parting with their money and being disappointed with the results.

Back in the states, Robin Young, a medical industry analyst from RRY Publications, estimates that gross sales of adult cellular therapies will be well over $100 million this year. By 2018, he says stem cell therapy revenues could grow to $8.2 billion.

“Adult derived cells are the ones that have been studied for the past 10 to 15 years and are ready for prime time,” says Debra Grega, the executive director of the Center for Stem Cell and Regenerative Medicine at Case Western Reserve University. “Large pharmaceutical companies are now wanting to get into the adult stem cell therapeutic area. That indicates to me that there is enough safety and enough efficacy that they are willing to put money in.”

Pharmaceutical giant Pfizer (NYSE:PFE)  announced in November that it would invest up to $100 million in regenerative research, which would include both adult and embryonic stem cell research, over a three to five year period.

The overall stem cell market, however, is still quite small. The California-based outfit Geron (NASDAQ:GERN) dominates the embryonic stem cell market, and is perhaps 10 years away from commercializing a spinal cord treatment based on its research.

The frontrunner in the adult stem cell space, according to Forbes, is Osiris Therapeutics, Inc.(NASDAQ:OSIR)- currently trading at $14.20 per share. Genzyme Corp. (NASDAQ:GENZ) has signed a partnership alliance with Osiris Therapeutics to develop two  late-stage adult stem cell treatments — Prochymal and Chondrogen — thought to be useful to treat a variety of diseases by controlling inflammation, promoting growth of new tissue and preventing scars. The deal will pay Osiris $130 million upfront ($75 million initially and the difference to be paid on July 1, 2009).  Assuming the drugs reach the marketplace, Genzyme will pay up to $1.25 billion in development, regulatory and sales milestone payments.

Osiris is focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic, and cardiovascular areas. Their principal biologic drug candidate, Prochymal, is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn’s disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA). Prochymal is also being developed for the repair of heart tissue following a heart attack, for protection of pancreatic islet cells in patients with type I diabetes, and for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The FDA could approve within a year which fights a painful illness called “graft-versus-host disease” which afflicts transplant recipients.  If they succeed, Osiris would be the first company to gain approval for a stem cell drug. Osiris will commercialize both drugs in the U.S. and Canada, and Genzyme will sell the drugs in all other countries.

Investors should be aware that there are only a limited number of stocks which are pure plays or semi-pure plays in the stem cell industry. Below are some of the companies working in the adult stem cell medicine space:

StemCells, Inc.(NASDAQ:STEM) – a company is engaged in the discovery and development of cell-based therapeutics to treat damage to, or degeneration of, major organ systems. Currently trading at $1.60 with a market cap of $164.09M.

Cytori Therapeutics Inc. (NASDAQ:CYTX) which develops, manufactures, and sells medical technologies to enable the practice of regenerative medicine. The Company’s commercial activities are focused on cosmetic and reconstructive surgery in Europe and Asia-Pacific, and stem and regenerative cell banking (cell preservation) in worldwide. Its product pipeline includes the development of new treatments for cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, liver and renal disease and pelvic health conditions. They currently trade at $3.55 with a market cap of $121.02M.

Aastrom Biosciences, Inc.(NASDAQ:ASTM) engaged in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s tissue repair cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting vascular, bone, cardiac and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. Late last month, the company made headlines after temporarily suspending enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The stock trades at $0.36 pps with a market cap of $58.44M.

ThermoGenesis Corp.(NASDAQ:KOOL) designs, manufactures and markets automated and semi-automated devices and single-use processing disposables that enable hospitals and blood banks to manufacture a therapeutic dose of stem cells, wound healing proteins or growth factors from a single unit of cord blood or the patient’s own blood in less than one hour. They currently trade at just under $0.70 and have a market cap of $37.02M.

Opexa Therapeutics, Inc. (Nasdaq:OPEXA) is a biopharmaceutical company developing autologous cellular therapies with the potential to treat major illnesses, including multiple sclerosis (MS) and diabetes. The Company has a global license from Baylor College of Medicine (or Baylor) to an individualized T-cell therapeutic vaccine, Tovaxin, which is in clinical development for the treatment of MS. MS is the result of a person’s own T-cells attacking the myelin sheath that coats the nerve cells of the central nervous system (CNS). Shares currently trade under $0.60 with a market cap of $7.29M.

The human placenta could be an important source of stem cells for curing leukemia, sickle cell disease and other blood-related disorders, a new study reveals.

These stem cells appear to have distinct advantages over the techniques currently used to fight such diseases, and they may one day provide an alternative treatment for people who cannot find matching bone marrow donors, researchers said.

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Scientists at Children’s Hospital Oakland obtained placentas from consenting women who had cesarean sections at Alta Bates Summit Medical Center in Berkeley.

They found that the placentas contained large numbers of blood-producing stem cells, which they were able to remove and grow in a cell culture.

“Yes, the potential is there,” said senior scientist Frans Kuypers. “Yes, you can get them out, and yes, they’re viable.”

One big advantage of such stem cells is that they do not require the perfect match needed for those who have bone marrow transplants, Kuypers said, because they do not trigger the same strong immune system response.

Today, scientists often seek to cure people who have leukemia and other blood-related disorders by giving them stem cell-rich bone marrow from donors who have closely matched tissue types. The transplanted bone marrow makes healthy blood cells to replace the faulty ones.

But if the donor has a different tissue type, the recipient’s body will not recognize the new cells and
will attack them, leading to what is known as graft-versus-host disease.The placental stem cells, like umbilical cord blood, “are much more tolerant with respect to matching,” Kuypers said.

The findings, which will appear in the July issue of Experimental Biology and Medicine, could represent especially good news for African-Americans, Asians and multiracial individuals, who often have difficulty obtaining compatible bone marrow donors.

“Many minorities cannot find a match in the national donor program, and as a consequence of that, they may die,” said Dr. Bert Lubin, senior vice president of research for Children’s Hospital.

Despite the hopeful signs of placental stem cells, their widespread use is probably several years away. Children’s Hospital will seek to raise the money to do clinical trials in humans.

The study serves as an important reminder that research in California should not focus solely on embryonic stem cells, which have the ability to transform into any cell type, said Hanna Mikkola, a researcher with the Broad Stem Cell Research Center at UCLA.

Embryonic stem cells hold great promise, but they also have raised concerns about whether they will form tumors or create an ear, for example, where physicians wanted them to produce blood.

The placental stem cells have already matured to the point where scientists know what they will get — they will produce red or white blood cells or platelets.

“Nature made them, so they’re perfect,” said Mikkola, who was not involved with the Children’s Hospital study. “That’s why bone marrow transplantation has worked so well. We shouldn’t ignore putting effort on looking at how we can better utilize the stem cells that have already been made.”

Another common way to cure children with blood-related disorders is to transplant them with stem cells from umbilical cord blood. Researchers believe these cells are virtually identical to the ones found in the placenta.

Since 1997, when their sibling donor cord blood transplantation program began, Children’s Hospital has cured more than 100 young people with blood-related disorders.

But there is a drawback to this approach: Umbilical cords provide only a small number of stem cells, making adult transplants difficult.

One of the study’s more promising findings is that the placenta has a several-fold increase in the number of stem cells compared when with cord blood, which could make it easier to transplant adults and larger children.

Leaders at Children’s Hospital were enthused this month to receive a $9.8 million gift from Hayward resident Dolores Jordan to fund research in cellular therapies, including bone marrow and cord blood transplantation.

But more money is needed to further the research on placental stem cells, Lubin said. He and his colleagues expressed frustration that they have not been able to obtain the multimillion-dollar grants that many universities have received from the state agency for embryonic stem cell research, especially since therapies from such research often are many years away.

“No one has been cured by an embryonic stem cell,” Kuypers said. “We are able to cure folks with (blood) stem cells, and you have to wonder, what is important?”