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
Stem cells have yet to make it into mainstream civilian medicine, but that hasn't stopped the US military betting on them to save its personnel if there's a nuclear explosion or radiological attack.
On 3 January, the Department of Defense awarded a contract to two biotech firms to develop a treatment for radiation sickness based on stem cells extracted from the bone marrow of healthy adult donors. If the treatment, known as Prochymal, wins approval from the Food and Drug Administration, the Pentagon will purchase up to 20,000 doses at a total cost - including funding for development - of $224.7 million.
High doses of radiation kill by damaging the DNA of fast-dividing cells in the gut and bone marrow. If victims survive the diarrhoea, intestinal bleeding and loss of water caused by damage to their gut linings, they may succumb to fatal infections in the following weeks as ...
continune at:http://www.newscientist.com/article/mg19726383.200-us-funds-stemcell-therapy-for-radiation-sickness.html
Cancer stem cells might hold clue to melanoma growth
Globe Staff / January 17, 2008
In a key step from theory to possible treatment for melanoma patients, scientists in Boston report today that they were able to beat back a deadly human skin cancer in mice by targeting and destroying stem cells in the tumors.
The findings on malignant melanoma add weight to the growing belief among scientists that many types of cancer recur after treatment because small, resilient groups of stem cells survive and start multiplying again.
The research, published in tomorrow's journal Nature, shows that attacking melanoma stem cells is enough to halt a tumor's growth, said Dr. Markus Frank of Children's Hospital Boston, senior author on the paper. It thus offers new hope that this strategy will also work in humans - perhaps, researchers say, within just a few years.
"If this works with melanoma, this may also work with other tumors that are notoriously difficult to treat" once they have spread, said Dr. George Murphy, an author of the paper and chief of skin pathology at Brigham and Women's Hospital.
For more than a decade, scientists have been researching the theory that stem cells might be the worst villains in cancer, and the work has gathered momentum as stem cell populations have been discovered in cancers ranging from brain tumors to leukemia. Under a microscope, stem cells look like other cancer cells, but they can drive the growth of cancerous tumors in much the same way that normal stem cells can regenerate the body's healthy tissues
The paper is exciting and well done, said Dr. Peter Dirks, researcher of stem cells and brain tumors at the University of Toronto who was not involved in the work.
He cautioned, however, that this latest study, as well as others on cancer stem cells, are only preliminary, and it remains to be seen how broadly applicable the results are. Also, much of the work still awaits replication by other labs, he said.
"It's relatively early stages," he said, though he says he understands why the whole idea of cancer stem cells has recently "hit prime time: Because if you could treat those cells, maybe we'd have more effective, more long-lasting, more definitive cures for cancer. This [new] study is definitely a step in that direction."
One other concern that must be addressed with future research: whether killing the cancer stem cells brings with it "unexpected toxicity," hurting normal cells that use the same protein, said John E. Dick, also at the University of Toronto.
The study, whose first author was Tobias Schatton, focused on a protein lying on the surface of melanoma stem cells called ABCB5. Frank and his team, including his wife, Natasha Frank, had already shown that ABCB5 was a telltale marker for cells that could resist chemotherapy.
They set out to see whether melanoma cells that test positive for ABCB5 not only resist attack from treatments such as chemotherapy, but also serve as the seeds that then develop into more cancer.
What would happen, they wondered, if those nefarious cells were knocked out? Using monoclonal antibodies - molecular weapons that can hit highly specific targets - they went after the ABCB5-positive cells in human melanoma tumors grafted onto mice.
Tumor growth was "significantly inhibited," they report. Only three out of 11 mice developed new tumors, compared with 28 out of 28 mice whose cancer stem cells were left alone.
ABCB5 is actually a molecule that helps stem cells get rid of toxins - such as chemotherapy drugs - and thus helps tumors survive, Murphy said. "It's the very molecule that helps protect them that we have used to identify them."
Even if further experiments continue to look promising, it will likely be at least two or three years before the stem-cell strategy could start being tested in humans with melanoma, Frank said. But his lab will immediately try to develop the best possible antibodies for attacking melanoma stem cells, and will also use their findings to try to understand more about the biology of cancer stem cells, he said.
Malignant melanoma is the deadliest form of skin cancer, but it is easily treatable if caught early. Once it spreads, the disease is usually fatal. It kills an estimated 8,000 Americans per year out of a total 60,000 diagnosed.
Article From:http://www.boston.com/news/nation/articles/2008/01/17/cancer_stem_cells_might_hold_clue_to_melanoma_growth/
Joe C Mathew / New Delhi January 16, 2008
HEALTH: Reliance, Lifecell and , have emerged leaders in the stem cell banking sector.
It was a keen desire to secure the future of his soon-to-be born baby that made Japin Sibal, a young IT professional from Gurgaon, do an Internet search for various savings schemes available before him.
Weeks after, he zeroed in on one option — which was suggested to him by a friend and reinforced by his online enquiry — to bank his child’s cord blood stem cell.
Across metros and major towns of India, hundreds of young parents are doing what Sibal has done — to harvest and preserve their child’s cord blood for possible use in stem cell therapies for the baby or its immediate relatives. With 25 million births happening annually, stem cell banking in India offers great growth potential.
“I decided to go for stem cell banking for my child as I was confident of its usefulness. I found a lot of material on the Internet that suggested possible therapeutic opportunities using cord blood stem cells. Even our doctor suggested to go ahead,” Sibal says.
Seizing the opportunity, entrepreneurs — ranging from India’s biggest corporate player Reliance to a local NGO — are making early investments in setting up umbilical cord blood banks across the country.
While Reliance, Lifecell and Cryobank have already established a national footprint in cord blood stem cell banking, regional players are seeing this as a futuristic business option.
Leading the race is Chennai’s Lifecell, which is known to have harvested over 10,000 units of such stem cells through its 20 regional centres in the last two years.
The company, which holds an accreditation from the American Association of Blood Banks (AABB) for its facility, charges around Rs 70,000 for preserving each unit of cord blood component for a period of 21 years.
“Parents banking their baby’s umbilical cord blood stem cells with an AABB-accredited bank can be assured that the blood sample has been qualified, collected, tested, processed, and stored according to internationally approved and recognised standards. Moreover, this accreditation allows access to the banked cord blood from any part of the world, when needed,” Arasan, CEO, Lifecell, says.
Reliance Life Sciences (RLS), which offers stem cell banking services under the “Reli Cord” brand, is also in the process of getting a similar accreditation. RLS is known to have direct presence in at least 30 locations from where cord blood stem cells are harvested.
Cryobanks International India, a joint venture of Cryobanks of the United States and India’s largest franchise bottler RK Jaipuria Group, is the latest entrant having a national presence. Gurgaon-based Cryobanks, which started operations 18 months ago, has already managed to collect 1,500 units.
The company, which also operates in 30 cities, is looking at harvesting at least 5,000 units during 2008. While the prices offered by all three are the same, Cryobanks has introduced installment schemes. Sibal, for instance, opted for a five-year installment programme.
“We are in the process of signing contracts with some IT majors to introduce company-sponsored stem cell harvesting programmes for their employees. The employee with have to bear only 50 per cent of the expenses as the balance will be paid by the employer,” Aasim Ghazi, head (marketing), Cryobanks, says.
Interestingly, Cryobanks has tied up with the RK Jaipuria Group and polyester major Indo Rama Group to set up a cord blood bank facility in Thailand.
The latest to foray into the sector is the Chennai-based not-for-profit organisation Jeevan Blood Bank and Research Centre. The move is significant because of the organisation’s stress on public stem cell banking over “private banking” as practiced by other players.
While all three existing players have a “public banking” concept, the majority of the cases handled by them today are from the “private banking” segment.
Jeevan attempts to promote “public banking”, which means harvesting and preservation of cord blood samples received through donations. While the “donor” will have no rights over the stem cells, the “recipient” will have to pay for the expenses incurred by Jeevan in preserving the cells.
“We plan to provide stem cells for free to poor patients and charge Rs one lakh from the rich as cross subsidy,” P Srinivasan, chairman, Jeevan Blood Bank and Research Centre, says.
According to him, not many players will venture into “public banking” because it involves huge investment and a high maintenance cost.
Even though stem cell banking has started to pick up, the centres that could make use of these cells and offer treatments are few in number.
However, Lifecell offers solution for that problem. In November 2007, it announced the setting up of Tricell, its therapeutic unit attached to Ramachandra Medical University, Chennai.
“While Lifecell will go ahead with stem cell banking business, Tricell will offer the treatment,” a company spokesperson says.
According to a government official, stem cell banking will become a public health priority only after its benefits are proved.
“Of the 75 type of diseases that have been approved for stem cell research, only a handful are a proven success. Unless it becomes a necessity for masses, government initiatives may not happen,” he says.
The industry seems to be hopeful. So are the NGOs, and the patients.
Artilce From :http://www.business-standard.com/common/storypage.php?autono=310816&leftnm=5&subLeft=0&chkFlg=
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