By Sharon L. Peters, Special for USA TODAY
A crooked front wrist, evident when she was a puppy, was just the beginning. Eventually, arthritis ravaged every joint. "We tried everything" to relieve the pain and maintain her mobility, Hammer says. But by last fall, at age 11, Maggie was "creaky, creaky, didn't want to get up, couldn't go for walks." She kept her head low because of pain and wasn't very interested in food.
"Maggie was a mess," says Mary Anne Smith, the dog's veterinarian since puppyhood. "She had issues in all four legs and quite possibly in her back." She compares the dog to a car "with four low tires and, on some days, three lows and a flat."
Around Thanksgiving, on Smith's recommendation, Hammer took Maggie to Colorado Springs veterinarian James Gaynor, who specializes in pain management and is among about 250 veterinarians trained in a cutting-edge therapy using stem cells extracted from a dog's own fat. The process, patented and made commercially available by California-based Vet-Stem, has generated excitement in veterinary circles. Practitioners gave a session last month at the North American Veterinary Conference in Orlando; they'll speak at the Western Veterinary Conference in Las Vegas next week and give a symposium at the American Veterinary Medical Association's July conference in New Orleans.
'She's a different dog'
Nearly 300 dogs have had the procedure, says Vet-Stem founder and veterinarian Bob Harman, and 85% of those the company has been able to follow up with experienced "slight to very substantial" improvement.
Within days of Maggie's procedure, she felt better; today, "she's a different dog," Hammer says. "She's able to walk, is pretty fast on her feet, and she wags her tail, something she hasn't been able to do for years."
The procedure, which runs $2,000 to $2,500, involves surgically removing about 2 tablespoons of fat from the dog and shipping it overnight to Vet-Stem, which isolates stem cells and returns them in syringes to the vet, who injects joints.
"This is probably the most exciting development I've seen in 25 years," says Beaverton, Ore., veterinarian Tim McCarthy, who has treated about 20 dogs, most in association with arthroscopic surgery; "only one didn't get any better."
Stem cells from fat and bone marrow have been investigated for both human and animal applications (several veterinary schools are engaged in studies) in recent years. It's known that stem cells are regenerative, take up residence around injured tissue and have anti-inflammatory properties, but much of how they work and why is unknown, Vet-Stem molecular biologist and veterinarian Linda Black says.
The approach doesn't require Food and Drug Administration approval because "minimally manipulated" cells are extracted and re-injected into the same animal, she says. And because animals receive their own cells, there's no rejection.
Apart from the normal risk attached to the anesthesia, Harman says, there seems to be no downside except for rare brief inflammation at the extraction site.
Half the veterinarians who have been credentialed (through attending a half-day session or completing a four-hour online course) to do the process on small animals practice in California; 25 states have no one trained in the process, according to a list posted on the Vet-Stem website, which names 200 of the 250.
Vet-Stem first began using the process in 2004 on horses with tendon, ligament and joint problems (455 large-animal vets are certified), and most improved. Critics say most of them would have healed on their own with time, a position many of the animals' trainers dispute. In canine applications, little criticism has emerged.
"Everything I've heard so far has been very positive," says Brenda Salinardi, a veterinarian at Oregon State University Veterinary Teaching Hospital. She has used the procedure on a dog with severe arthritis, which "is doing very well."
Gaynor has used stem cell therapy on 27 dogs "and all improved — some more than others," but he acknowledges many questions remain. It's unclear how long the positive effects will last, whether follow-up injections will improve results or which animals are unlikely to benefit.
A step for desperate owners
The unanswered questions are irrelevant to Gaynor's clients eager for help for their pets. Judy McCollam's Shetland sheepdog Cassie was so severely disabled by arthritis in her hips that "when we'd take her for walks, we'd wind up carrying her," she says. And "watching her get up from a nap was like watching a really old dog get up." Cassie was on strong painkillers, and she was not yet 2 years old. McCollam, of Fountain, Colo., opted for the stem cell procedure. Within days, Cassie was better, McCollam says, and two months later, "she seems not to be in any pain."
Owners who are desperate for an ailing dog to feel better can convince themselves interventions are helping when, in fact, by impartial measures, that's untrue. But veterinarians who have used the procedure say they've generally been able to chart measurable improvement.
Smith, who treated Maggie for more than a decade, says the dog is "hard to evaluate because she had multiple joint issues," but the veterinarian detected "marked improvement" soon after the procedure. "She is much more confident walking, her gait is much more fluid, and she has greater mobility getting up and down."
Vet-Stem is investigating a handful of additional dog and cat ailments and diseases that might benefit from stem cell therapy.
This Article From:http://www.usatoday.com/news/health/2008-02-12-dog-arthritis_N.htmGeron CEO plans embryonic stem cell tests in humans this spring if the biotech meets the FDA's 'high bar.'
NEW YORK (CNNMoney.com) -- The first experiments using human embryonic stem cells in human subjects could begin within a few months, the chief executive of biotech Geron said Monday.
At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.
This assumes that the Food and Drug Administration gives Geron a green light to proceed with the human test. Okarma said the FDA will set a "high bar" in regulating this new type of science.
Ren Benjamin, analyst for Rodman & Renshaw, believes the regulatory process could be time-consuming, because it's unprecedented.
"This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise," he said.
Geron (GERN), based in Menlo Park, Calif., is also in early-stage studies with stem cell-based drugs for diabetes and heart failure. All of these experimental treatments are years away from potentially entering the market.
Advanced Cell Technology Inc. and Novocell Inc. also use human embryonic stem cells, but Geron is the only one of the these companies that's traded on the Nasdaq. Advanced Cell plans to begin testing in humans this year, but Novocell is further behind.
Neuralstem (CUR) uses stem cells from aborted fetuses to research potential treatments for spinal cord injuries. Like Geron and Advanced Cell Technology, Neuralstem plans to begin testing in humans this year, assuming that the FDA gives it the go-ahead.
Cytori Therapeutics (CYTX) and Osiris Therapeutics (OSIR) use stem cells taken from adult human tissue, which insulates from the controversy surrounding the use of human embryonic stem cells, which are obtained through in vitro fertilization.
Human-based embryonic stem cells are prized by researchers for their ability to regenerate quickly and morph into different types of cells. Supporters believe their use could someday help people with spinal injuries walk again or cure patients with degenerative diseases like Alzheimer's and Parkinson's.
But the pro-life contingent, including President Bush, opposes using human-derived stem cells, on the grounds that it creates embryos only to destroy them. Supporters of the science dispute that notion, saying that the blastocysts used as stem cell sources would be thrown out as medical waste if they weren't used in research.
In 2001, President Bush limited federal funding for human-derived stem cells to only those lines that existed at the time. In 2007, he vetoed a Congressional bill to lift those restrictions.
But in November, scientists unveiled a new type of experimental technology on Nov. 21 that sent Geron's stock into a volatile tailspin. Research teams from the University of Wisconsin in Madison and the University of Kyoto in Japan separately announced that they'd "reprogrammed" adult cells to act like embryonic stem cells.
Geron's stock has fallen more than 40 percent since then, though Okarma shrugged off the potential threat of reprogramming because it's still in the infantile stages.
"The natural human embryonic stem cell is the gold standard and we have yet to see anything else come close," Okarma said at the BIO CEO conference Monday.
But Benjamin of Rodman & Renshaw doesn't believe reprogramming poses an immediate threat to Geron.
"I think [reprogramming] is very intriguing and has a lot of potential, but it's at a nascent stage that I consider more noise than anything else," said Benjamin.
Mark Gross, a physics professor at California State University who was attending the BIO CEO conference as a potential investor, agreed that reprogramming technology is in too early of a stage to threaten Geron.
"[Reprogramming] is promising, but these things take time and we don't know which path will lead to fruition and which will lead to a dead end," he saidArticle From CNNmoney.com
Cord Blood America Supports Trend From New York, California for States to Inform Parents of the Advantages of Umbilical Cord Blood Storage
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SANTA MONICA, Calif., Feb 06, 2008 /PRNewswire-FirstCall via COMTEX/ -- Cord Blood America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company (http://www.cordblood-america.com ) focused on bringing the life saving potential of stem cells to families nationwide and internationally, today said it believes the trend established in 2007 for states to legislate that consumers should be made aware of the advantages of umbilical cord blood storage will continue in 2008 and beyond.
New York State in 2007 became the first in the nation to sign into law an Umbilical Cord Blood Bill mandating that the state's Department of Health develop a program to make the public aware of the benefits of umbilical cord blood banking. California subsequently followed, enacting legislation encouraging the collection of umbilical cord blood stem cells.
"Many young couples and growing families do not yet know how important it is to consider storing umbilical cord blood after the birth of a child, even though storing umbilical cord blood could be a life saver if someone in the family develops certain serious diseases," said New York Assemblyman Joseph R. Lentol. "Pregnant women should be receiving information early so they can make an educated decision, especially since there are now more than 60 diseases that can be helped through cord blood transplantation, including leukemia, lymphomas and other cancers."
California Assemblyman Anthony Portantino stressed: "Why are we throwing something away that we know is such a healing product. It has the power to do miracles."
"We look forward to more states requiring their health department to inform families about the benefits of umbilical cord blood storage, which is safe and non-controversial," said Matthew Schissler, CEO, Cord Blood America. "We salute this Coast to Coast effort in providing solid, reliable information to potential new parents."
About Cord Blood America
Cord Blood America (OTC Bulletin Board: CBAI) is the parent company of CorCell, which facilitates umbilical cord blood stem cell preservation for expectant parents and their children. Its mission is to be the most respected stem cell preservation company in the industry. Collected through a safe and non-invasive process, cord blood stem cells offer a powerful and potentially life-saving resource for treating a growing number of ailments, including cancer, leukemia, blood, and immune disorders. To find out more about Cord Blood America, Inc. (OTC Bulletin Board: CBAI), visit our website at http://www.corcell.com. For investor information, visit http://www.cordblood-america.com.
from:http://www.foxbusiness.com/markets/industries/health-care/article/cord-blood-america-supports-trend-new-york-california-states-inform-parents_467083_10.html
The Government has agreed to back down on strict laws planned for embryonic stem-cell experiments after a “compelling case” was made by leading scientists in a letter to The Times.
The letter, published last week, expressed alarm that the Human Fertilisation and Embryology Bill would delay potentially life-saving research by requiring all tissue used to create cloned embryonic stem cells to have the explicit consent of its donor.
The Bill, which is passing through Parliament, was set to outlaw access to most of the tissue banks that act as vast libraries of the genes that contribute to serious disorders.
More than 50 biomedical researchers and administrators, including four Nobel prizewinners, have told ministers that such strict measures would deny stem-cell scientists the use of tissue banks for studying diseases such as muscular dystrophy, Parkinson’s and diabetes.
Picture From:http://www.telegraph.co.uk
The tissue banks enable scientists to create cloned embryos that can be implanted with the genetic material of patients, assisting research into how the illnesses develop.
The Government’s justification for requiring “express consent” had been that some patients who agreed to donate cells may not have realised that their tissue could later be used for cloning. The letter in The Times said that the requirement jeopardised years of expensive research and the cultivation of unique tissue samples as raw material for cloning.
As tissue was collected before it became possible to clone embryos in this way, the scientists argued that it would have been impossible for anonymous donors to give permission for their DNA to be used in embryonic stem-cell models of diseases. Signatories included the Nobel medicine laureates Sir Martin Evans, Sir Paul Nurse, Sir John Sulston and Sir Tim Hunt, as well as leading stem-cell experts such as Sir Ian Wilmut, Dame Julia Polak and Professor Stephen Minger.
The Government is also considering changing a second measure in the Bill, which will further limit stem-cell research by blocking the use of any tissue from children even if their parents gave consent.
Ministers were reluctant to consider any changes to the Bill, but after a debate in the House of Lords last Tuesday the Department of Health conceded the need to allow exceptions.
In a letter sent this week to peers who took part in the debate in the Lords, the department concedes: “A compelling case has been made that the requirement for express consent could, in certain circumstances, impose a significant burden in this field.”
Evan Harris, the Liberal Democrat MP who organised the letter to The Times, said yesterday: “Plaudits to the scientists for speaking out and the Government for listening.”
The Bill is due to enter the Commons in the spring.
Article From:http://www.timesonline.co.uk/tol/news/uk/science/article3292055.ece
LANSING -- A group seeking to expand medical research using embryonic stem cells in Michigan announced Tuesday that it has submitted language for a proposed constitutional amendment that would end the state's prohibition on the destruction of human embryos for research purposes.
The Stem Cell Ballot Question Committee in Michigan wants to authorize the use of excess or unsuitable embryos from fertility clinics that "would otherwise be discarded unless they are used for research." In contrast to legislation aimed at opening up research on stem cells, the ballot proposal affirms Michigan's law prohibiting human cloning.
Backers of the proposal would like to collect enough petition signatures -- 380,126 -- to put the issue before voters in November.
Opponents, led by the Michigan Catholic Conference and Right to Life organizations, are unlikely to soften their views, even without cloning issues.
Catholic Conference spokesman Dave Maluchnik said Tuesday that the measure is under review but that efforts to legalize research that destroys embryos is "terribly unfortunate," reversing 30 years of public policy in Michigan.
Advocates of embryonic stem-cell research say stem cells derived from embryos offer immense promise for treatment of chronic disease and injury. A state elections panel is to review the ballot proposal language Friday. The committee has a July 7 deadline to collect the signatures to qualify for the November ballot.
Contact DAWSON BELL at 313-222-6609 or dbell@freepress.com.Article From:http://www.freep.com/apps/pbcs.dll/article?AID=/20080130/NEWS06/801300392/1008
By Madeline Vann
HealthDay Reporter
Sunday, January 20, 2008; 12:00 AM
SUNDAY, Jan. 20 (HealthDay News) -- Researchers have coaxed embryonic mouse stem cells to grow into healthy muscle tissue, in a feat that creates new possibilities for the treatment of Duchenne muscular dystrophy (DMD).
DMD is the most common of nine types of muscular dystrophy, which is characterized by a lack of the protein dystrophin in voluntary muscles, such as those in the arms and legs. Dystrophin plays a key role in building and repairing muscle; without it, muscles deteriorate and lose function.
The University of Texas Southwestern Medical Center team focused on developing embryonic stem cells containing the gene Pax3, which triggers cells to grow into muscle tissue that will produce dystrophin.
"Embryonic stem cells can make every tissue in the body. We instructed these cells to make more skeletal muscle, and from a crowd of cells," explained study author Rita Perlingeiro. "We found a way to pull out only the ones destined to make muscle. These two steps combined resulted in a cell population capable of making muscle in a mouse with muscular dystrophy and, very importantly, the new muscle is stronger."
This is one of the few studies to test the ability of embryonic stem cells to grow in adult muscle tissue, the researchers added. The method they used also managed to avoid the risk of tumor formation in the mice.
One expert lauded the study, which appears in the Jan. 20 online issue ofNature Medicine, as a strong first step.
"By way of experiments done with mice, the paper offers a compelling 'proof of principle,' that embryonic stem cells can be turned into muscle-producing cells in the laboratory and used to deliver healthy muscle to people with Duchenne muscular dystrophy," said Paul Muhlrad, research program coordinator for the Muscular Dystrophy Association.
The researchers noted it was only necessary to regenerate a portion of the muscle tissue for the mice to regain some control. However, the process requires refining before it can be tried in humans, they added.
"At the present time, no one has yet demonstrated that genetic manipulation of human embryonic stem cells can be used to derive functional skeletal muscle progenitors from these cells, so it's far too early to tell whether this technique could lead to any potential clinical application," said Perlingeiro. "The main hurdle is to make sure we can indeed combine successfully these two approaches, and test these cells exhaustively in mouse models before we think about clinical trials."
Muhlrad also cautioned that this research is a long way from human use.
"While mice provide an excellent model system, experiments that work in mice don't always readily transfer to humans. Scientists would probably want to replicate the experiments in dog models of muscular dystrophy before moving on to human studies," Muhlrad said. Additionally, the mice had to take immunosuppressants to prevent their bodies from rejecting cells from another mouse. The ideal approach would be to use a body's own stem cells to avoid the issue of rejection.
More information
To learn more about the different types of muscular dystrophy, visit the Muscular Dystrophy Association.
SOURCES: Paul Muhlrad, Ph.D., research program coordinator, Muscular Dystrophy Association, Tucson, Ariz.; Rita Perlingeiro, Ph.D., assistant professor, developmental biology and molecular biology, Department of Developmental Biology, University of Texas Southwestern Medical Center at Dallas; Jan. 20, 2008,Nature Medicineonline
from:http://www.washingtonpost.com/wp-dyn/content/article/2008/01/20/AR2008012001004.html
BIOTECH COMPANY DEVELOPED BRAIN DISEASE TREATMENT
By Steve Johnson
Mercury News
One of six children with a brain disease who were given a stem-cell treatment developed by StemCells of Palo Alto in a groundbreaking study, has died apparently from her disease, the company said Friday.
The unidentified 9-year-old girl, who died earlier this week, had been given the nerve stem cells derived from fetal tissue in January last year to treat neuronal ceroid lipofuscinosis, also known as Batten disease, the company said in a prepared statement. The disease is a rare and always fatal condition that affects children.
The girl, who received the treatment at Oregon Health & Science University's Doernbecher Children's Hospital, became critically ill from an apparent viral infection, seizures and respiratory distress, and was hospitalized nearly two weeks ago, the statement said.
Based upon an initial review by Doernbecher doctors, a committee of experts monitoring the study and StemCells' medical specialists, the girl's death was believed due to the natural progression of her disease rather than from the stem cells she received, the company said.
Children with Batten disease - which is caused by genetic mutations - suffer seizures and progressive loss of motor skills, sight and mental capacity, before eventually becoming blind, bedridden and unable to communicate. The stem-cell treatment was the first ever tried with children suffering from the malady.
StemCells initially asked the U.S. Food and Drug Administration in December
2004 for permission to conduct the unprecedented test on children. After asking the company for more information about how the surgery would be done and whether it risked causing cancer, the federal agency gave its permission Oct. 20, 2005.
Batten disease is caused by a defective gene that fails to create an enzyme the brain needs. By injecting the fetal stem cells into the brains of the six children, researchers involved in the study said they hoped the cells would help the brains produce the missing enzyme.
StemCells' statement added that the company is continuing to investigate the death and has been in contact with the U.S. Food and Drug Administration about the matter.
"These patients are in the very late stage of the disease and that is one of the criteria of enrollment" in the study, which is designed to determine if the treatment has any unsafe side effects, said StemCells Chief Executive Officer, Martin McGlynn.
"Coming into the study they have no prospect of survival," he added. The fact that one of them has died is a reminder of "how important it is to find a therapy or even a cure for this devastating disease."
All of the children who received the treatment were under the age of 13, said McGlynn, who noted that the surviving youngsters will be monitored by medical officials until the early part of 2009, when the study is expected to be completed.
From:http://www.mercurynews.com/peninsula/ci_8018506?nclick_check=1
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