Echizen jellyfish (Photo courtesy of Riken)

Mainichi, Japan, February 2, 2009 — A glycoprotein found in jellyfish is effective in the treatment of osteoarthritis, announced a team of researchers at Tokai University that has been conducting tests on animals.

The team, led by Masato Sato, an associate professor of orthopedic surgery at Tokai University’s School of Medicine, will announce the results of its study at a March meeting of the Japanese Society of Regenerative Medicine set to take place in Tokyo.

Osteoarthritis is a condition caused by aging and injury in which cartilage in the joints wear thin, making walking difficult. Approximately 7 million people are said to suffer from it nationwide. Hyaluronic acid injected into the joints delay its progression, but no fundamental cure exists.

Riken, an independent administrative agency that conducts research in science and technology, discovered the protein qniumucin in Echizen jellyfish in 2007. It has a structure similar to that of mucin, the main substance found in human stomach acid.

Sato and the other researchers focused on the fact that the levels of mucin found on the surface of cartilage in the joints of people suffering from osteoarthritis were low. Tests conducted on rabbits with osteoarthritis found more cartilage recovery among those injected with both hyaluronic acid and qniumucin extracted from moon jellyfish and Echizen jellyfish, than with those who were injected only with hyaluronic acid. The extent of cartilage damage and the area affected also greatly improved among the former group.

“We suspect that the hyaluronic acid wraps itself around the qniumucin, creating a synergistic effect that allows the substances to remain in the cartilage for a longer time,” says Sato. “We’d like to make this applicable for people after confirming its effects on larger animals.”


Scientific American, by Coco Ballantyne, February 2, 2009 — Now that some of the gates blocking embryonic stem cell research in the U.S. may be opening thanks to the Obama administration, the ethical guidelines for such research may be getting a closer look. A key question: Should research on embryonic stem cells be subject to the same stringent rules that govern studies on human beings?

That was one of the questions that came up last night at a meeting of the New York Stem Cell Foundation. Harold Varmus—an Obama supporter who now co-chairs the President’s Council of Advisers on Science and Technology—told a crowd gathered at the

Harvard Club in Midtown Manhattan that there is “reason to believe that there will be some executive order in the near future to reverse the Bush doctrine,” aka the ban on federal funding for research on embryonic stem-cell lines produced after August 9, 2001.

Such a reversal would presumably mean more federal funding for embryonic stem cell research, and Lawrence Tabak, acting deputy director of the National Institutes of Health (NIH), said last night that the NIH is already preparing for the expected policy shift. As soon as the ban is lifted, the agency will move to develop a new set of guidelines that will, among other issues, detail which types of embryonic stem cell studies constitute human subjects research.

That’s an important distinction. To work with typical cell lines that cannot be linked to a living person, scientists needn’t obtain special clearance from the federal government. Human research is, understandably, subject to stricter ethical standards than other types of biomedical research. Scientists doing human subjects research are required to obtain pre-approval from institutional review boards (IRB’s)—ethics committees that monitor research conduct and protect the rights and welfare of study participants. Any university or private research institution that receives funding from the feds is required to have an IRB.

Everyone would agree that if stem cells are being used in humans—say in the Geron trial of stem cells in spinal cord injuries approved last week—the trials need a closer look. But does it make sense to put those stringent standards in place for what some would say is just a collection of cells, if a scientist is working in the lab?

We checked in with Josephine Johnston, a bioethicist at the Hastings Center, in Garrison, N.Y., for her thoughts. She says that certain types of studies involving human embryonic stem cells would already be considered human subjects research under current federal regulations, and thus protected by IRBs. “Human embryos in a dish are not considered human subjects, but the embryo donors might be,” Johnston says. If the embryo donors (mom and dad) identify themselves to scientists, providing personal data and perhaps even biological samples, then says Johnson, “they are pretty clearly human subjects.”

Imagine this scenario: You’re a member of a couple that has had a baby using in vitro fertilization. You give your extra embryos away, but you don’t want to participate in any research. (While it’s tough to estimate how many embryos are discarded every year, Johnston says there are some 400,000 frozen embryos stored in fertility clinics around the U.S., and some of these might eventually be donated to science.) Theoretically, there would be no link between you and those embryos, but remember that your DNA is in that cell line. “If you have the genetic material from an individual [contained within those embryos], might you be able to get identifying, private information about that person?” asks Johnston. “We don’t currently have the technology but it could be developed in the future.”

That squares with what Tabak told ScientificAmerican.com last night in response to a question prompted by vicka, one of our Twitter followers. (Oh yeah: We live-tweeted the meeting.) “The issue of identity becomes a key element” in the decision,” Tabak said.

Cytori announced that the first patient was enrolled in an investigator-initiated safety and feasibility study using adipose-derived stem and regenerative cells to treat stress urinary incontinence

NAGOYA, Japan | January 30, 2009 | Cytori announced that the first patient was enrolled in an investigator-initiated safety and feasibility study using adipose-derived stem and regenerative cells to treat stress urinary incontinence. The 10-patient study is being conducted independently by Nagoya University Hospital in Japan. Cytori’s Celution® 800 System is being used to process and extract the patients’ own adipose tissue-derived stem and regenerative cells at the time of surgery.

“The Celution System is uniquely able to provide real-time access to clinical grade stem and regenerative cells to meet the growing demand Cytori is seeing from physicians seeking regenerative medicine-based treatments,” said Seijiro Shirahama, President, Cytori Asia Pacific. “As a result, hospitals are increasingly interested in a Celution purchase to fill this need in the marketplace. This demand is partially reflected in the seven investigator-initiated clinical studies taking place in Japan which use the Celution System.”

As part of the study, stem cells were injected intra-muscularly into the sphincter as well as in combination with a measured volume of the patient’s own fat tissue to create a bulking agent to support the urethra. The study will evaluate safety, functional endpoints including intraurethral pressure and leak point pressure, as well as subjective assessments of patient and physician satisfaction. Current treatments include use of collagen as a bulking agent to provide pressure against and support the urethra.

“There are a growing number of scientific publications that show adipose derived stem and regenerative cells can ameliorate urinary incontinence,” said Momokazu Gotoh, M.D., Ph.D., Professor and Chairman, Department of Urology, Nagoya University Graduate School of Medicine. “Celution is the only feasible way to derive the cells in a clinically practical manner. This first case could not have gone better and the Celution System performed flawlessly.”

Stress urinary incontinence can have a significant impact on a patient’s quality of life, resulting in involuntary release of urine due a weakened urethral sphincter. The condition is more common in women and often comes about following child birth or menopause. It is estimated that approximately 9 million people in Japan, and more than 13 million women in the U.S., are affected by stress urinary incontinence.

About Cytori

Cytori’s (NASDAQ: CYTX – News) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients’ adult stem and regenerative cells. The Celution(R) 800 System is being introduced in Europe into the reconstructive surgery market while the Celution(R) 900 System is being commercialized globally for cryopreserving a patient’s own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

SOURCE: Cytori Therapeutics


EFluxMedia.com, February 2, 2009, San Francisco State University, UC Berkeley, UCSF, Stanford University, the J. David Gladstone Institutes and San Jose State University are among 26 institutions that will share in a $58 million training program to aid stem cell research from the California Institute for Regenerative Medicine (CIRM).

Nevertheless the governing board of the California stem cell agency is delaying $58 million in research grants at least until March because of the poor economy and credit market.

Voters created the California Institute for Regenerative Medicine in 2004 with $3 billion in borrowing power to promote stem cell research. The institute’s board has since awarded nearly $700 million to universities, institutes and research companies.

Nevertheless taking measures in this field is still a necessary action: “If we are to determine the potential of stem cells and other early-stage cells for treating disease, we need to prepare the brightest young stem cell scientists in the field and ensure that they are prepared to move basic research findings from the lab to the clinic,” Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF, said in a news release.

California scientists saw the stem cell institute as a way to diversify, and perhaps increase, their funding sources. Its promise prompted dozens of scientists, and even businesses, to move to California.

Moreover the institute plans to sell general-obligation bonds to deep-pocketed investors who have similar goals of curing disease, such as major foundations with a patient-advocacy bent. It needs to raise a minimum of $138 million just to fund the programs it has approved through the end of 2010, when it hopes the state budget mess is resolved

MS causes damage to nerve cells

Stem-cell transplants may control and even reverse multiple sclerosis symptoms if done early enough, a small study has suggested.

BBCNews.co.uk, February 2, 2009 — Not one of 21 adults with relapsing-remitting MS who had stem cells transplanted from their own bone marrow deteriorated over three years.

And 81% improved by at least one point on a scale of neurological disability, The Lancet Neurology reported.

Further tests are now planned, and a UK expert called the work “encouraging”.

MS is an autoimmune disease which affects about 85,000 people in the UK.

It is caused by a defect in the body’s immune system, which turns in on itself, causing damage to the nerves which can lead to symptoms including blurred vision, loss of balance and paralysis. At first, the condition mostly causes intermittent symptoms that are partly reversible.

Over a 10-15 year period after onset, most patients develop secondary-progressive MS, with gradual but irreversible neurological impairment.

It is not the first time this treatment – known as autologous non-myeloablative haemopoietic stem-cell transplantation – has been tried in people with MS, but there has not been a great deal of success.

The researchers at Northwestern University School of Medicine in Chicago said most other studies had tried the transplants in people with secondary-progressive MS where the damage had already been done.

In the latest trial patients with earlier stage disease who, despite treatment had had two relapses in the past year, were offered the transplant.

Immune system

Stem cells were harvested from the patients and frozen while drugs were given to remove the immune cells or lymphocytes causing the damage.

The stem cells were then transplanted back to replenish the immune system – effectively resetting it.

Five patients in the study relapsed, but went into remission after receiving other therapy.

The researchers are now doing a randomised controlled trial in a larger number of patients to compare the treatment with standard therapy.

Study leader Professor Richard Burt said this was the first MS study of any treatment to show reversal of damage.

“You don’t want to wait until the horse has left the barn before you close the barn door – you want to treat early.

“I think the reversal is the brain repairing itself.

“Once you’re at the progressive stage you have exceeded the ability of the brain to repair itself,” he said.

However, he cautioned that it was important to wait for the results of the larger trial.

And that he would not call it a cure but “changing the natural history of the disease”.

Dr Doug Brown, research manager at the MS Society, said the results were very encouraging.

“It’s exciting to see that in this trial not only is progression of disability halted, but damage appears to be reversed.

“Stem cells are showing more and more potential in the treatment of MS and the challenge we now face is proving their effectiveness in trials involving large numbers of people.”


“Stem cells are showing more and more potential in the treatment of MS and the challenge we now face is proving their effectiveness in trials involving large numbers of people.”
Dr Doug Brown, MS Society

Encouraging Stem Cell Research Published

MedicalNewsToday.com, February 2, 2009, — Researchers in America have reported encouraging results from a trial treating people with MS with stem cells derived from their bone marrow.

The study, reported in the Lancet Neurology, involved 21 people with relapsing/remitting MS who had had two relapses in the previous year despite treatment with beta interferon. The injections of stem cells followed courses of treatment with immune suppressing drugs.

Following treatment, the participants were followed for an average of three years. All 21 showed no worsening of disability as measured by the EDSS scale, and 17 improved by at least one point. 16 people experienced no further relapses following the stem cell treatment.

The researchers reported that this treatment is ‘a feasible procedure that not only seems to prevent neurological progression, but also appears to reverse neurological disability’. They drew attention to the need for larger, randomised trials.

Pam Macfarlane, Chief Executive of the MS Trust said, “These results are very encouraging and show the potential of stem cells as a treatment for MS. This is a small study and we look forward to larger trials with more people.”


“Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study.”
The Lancet Neurology, 30 January 2009


LiveNews.com.au, February 2, 2009 — A US biotech company says it plans to start this summer the world’s first study of a treatment based on human embryonic stem cells – a long-awaited project aimed at spinal cord injury.

The company gained federal permission this week to inject eight to 10 patients with cells derived from embryonic cells, said Dr Thomas Okarma, president and CEO of Geron Corp of Menlo Park, California.

The patients will be paraplegics, who can use their arms but can’t walk. They will receive a single injection within two weeks of their injury.

The study is aimed at testing the safety of the procedure, but doctors will also look for signs of improvement like return of sensation or movement in the legs, Okarma said.

Whatever its outcome, the study will mark a new chapter in the contentious history of embryonic stem cell research in the United States – a field where debate spilled out of the laboratory long ago and into national politics.

While some overseas doctors claim to use human embryonic stem cells in their clinics, stem cell experts said they knew of no previous human studies that use such cells.

“It’s a milestone and it’s a breakthrough for the field,” because Geron passed the safety hurdles for getting federal clearance to launch the study, said Ed Baetge, chief scientific officer of Novocell Inc. His company hopes to begin a similar human study for treating diabetes in a few years.

In addition, said spinal cord injury researcher Dr Wise Young of Rutgers University, “a lot of hope of the spinal cord injury community is riding on this trial”.

Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.

President Barack Obama has promised to relax the Bush administration’s restrictions on federal financing for such research. But Obama’s ascent to the White House had nothing to do with the US Food and Drug Administration’s granting permission for the new study, Okarma said in a telephone interview on Thursday.

In fact, the company says, the project involves stem cells that were eligible for federal funding under Bush, although no federal money was used to develop the experimental treatment or to pay for the human study.

Other human cells, called adult stem cells, have been tested before in people to treat heart problems, for example.

In the Geron study, the injections will be made in the spine at the site of damage. The work will be done in four to seven medical centres around the country, Okarma said.

Animal studies suggest that once injected, the cells will mature and repair what is essentially a lack of insulation around damaged nerves, and also pump out substances that nerves need to function and grow.

Apart from assessing safety, investigators will hope to see some signs of improvement in the patient, Okarma said. The idea is “not to make somebody … get up and dance the next day”, he said, but rather to provide some level of ability that can be improved by physical therapy.

Each patient will receive a low dose of anti-rejection drugs for about two months, because after that time the medications shouldn’t be needed, Okarma said. The study will follow each patient for at least a year.

Okarma said he can’t estimate how much such a therapy would cost if it proves effective, but that “this is not going to be a $US500,000 ($A762,195) price tag. It will be remarkably affordable … in the context of the value it provides.”

Evan Snyder, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla, California, said scientists in the field will focus chiefly on the study’s results about safety.

“The one hope that everybody has is that nothing bad happens,” he said.

Geron Corp has spent at least $US100 million ($A152.44 million) on human embryonic stem cell research. Founded in 1992, it does not have any therapies on the market.

However, the company is considered the world’s leading embryonic stem cell developer thanks to its claims on several key stem cell technologies. Geron helped finance researchers at the University of Wisconsin who first isolated human embryonic stem cells in 1998. The company has retained exclusive rights on several of those cell types.