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Early-stage ALS stem cell study clears initial safety hurdle

2011-10-26T16:01:06Z

A very small, early-stage clinical trial of a new fetal stem cell therapy for amyotrophic lateral sclerosis, better known as Lou Gehrig's disease, is hinting at its potential success. A team of investigators from the University of Michigan and Atlanta's Emory University say that the trial involving five ALS patients has produced no serious side effects

Landmark ALS stem cell trial moving into a critical phase

2011-03-16T08:31:37Z

Neuralstem's groundbreaking clinical trial of a stem cell therapy for Lou Gehrig's disease, or ALS, has hit a critical juncture. After sizing up the safety profile of the therapy in the first batch of patients treated in the study, investigators are preparing to take the next step: Moving from the lower to the upper part of the spinal cord and injecting stem cells in the hopes of protecting nerve cells required for breathing.

When the FDA offered a green light for the study back in the fall of 2009, investors pushed up the value of Neuralstem's shares by 57 percent. Since then the trial has been playing out at a painstakingly measured pace as researchers first set out to see if this radical new approach to ALS is safe for patients. Once regulators sign off, the principal investigator tells the Detroit News, she can begin to see if the treatment will offer an important survival benefit.

"Up until now, we've been targeting the lower part of the spine and if the therapy was effective--and that's only if--what would be retained would be the ability to walk," says Dr. Eva L. Feldman, the principal investigator. "Walking is not necessarily essential for survival. What is essential for survival is the ability to breathe." And while Feldman has been careful not to tout the potential for a cure or overstate the possible benefits of the therapy, she's consistently believed that stem cell therapy offers a big advance.

"In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles," she said back in 2009. "We don't want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS."

At Bio-Europe Spring in Milan, Neuralstem CEO Richard Garr noted today that the first 12 patients in the study will be treated by April, when Feldman will unveil results at an upcoming scientific meeting. While the Phase I study endpoint is focused on safety, investigators are also tracking several key secondary endpoints on efficacy, including motor function and respiratory impact. And Neuralstem plans to file an IND for a separate early-stage stroke trial in April. The stroke trial will use the same technology involved in the ALS study, says Garr, but probably won't be cleared until regulators have a chance to review the first safety data.

Says Garr: "The FDA is making is move very slow." But because investigators are working with patients early on, he adds, the company can gain some early insights on efficacy that will help advance later stage work.

Several early stage stem cell trials are now underway in the U.S. On Monday StemCells announced that it had launched the first study of a neural stem cell injection for spinal cord damage. And Geron is conducting the world's first study of an embryonic stem cell treatment for spinal cord damage. StemCells will recruit a dozen patients with injuries which are three to 12 months old.

- here's the story from the Detroit News

National award encourages bio-science student researchers

2011-10-17T23:41:00Z

A key challenge for the bio-sciences sector is to keep its best research graduates in science and in Australia. The national student awards recognise and encourage promising research students and raise awareness of biosciences research translation and applications.

Umbilical cord holds key to heart repair: Study | Health & Fitness | Life | Toronto Sun

2011-10-17T15:45:53Z

HHS’s birth-control rules intrude on Catholic values

2011-09-30T13:29:39Z

The Department of Health and Human Services proposed some regulations a few weeks ago to implement a part of the 2010 health-care law, and it asked concerned parties to file comments on the regulations by Friday. In a section of the Affordable Care Act that didn’t get much public attention during the debates last year, Congress asked HHS to prescribe a list of “preventive services for women” that health-care plans across the country would have to provide to subscribers at no additional cost.

Read full article >>

In-vitro fertilization linked to rare genetic disorders

2011-09-26T04:25:35Z

A Toronto geneticist is calling for more study of a link between fertility treatment and certain rare genetic disorders

Surrogates often deeply upset by process: study

2011-09-23T11:58:58Z

Their key role in the arcane world of surrogate motherhood has received relatively little scientific examination, but it turns out surrogates are often deeply upset by the process, a new Canadian study suggests

Republicans seek to prioritize stem cell research programs - The Hill's Floor Action

2011-09-21T16:07:55Z

Embryonic, induced pluripotent stem cells found to be similar

2011-09-12T14:58:24Z

It has been four years since researchers first took human adult cells and genetically coaxed them into behaving like embryonic stem cells. From there, they can reprogram the resulting induced pluripotent stem cells (iPSC) into forming any kind of cell desired. But one reason iPSCs have not been more-widely adopted in the clinic and in research is that it is not known yet whether the resulting cells can compare with their natural counterpart, embryonic stem cells. For that reason, many of the iPSC experiments are conducted using embryonic cells as well. Now, researchers from the University of Wisconsin-Madison have taken a step to answer the question. The result: iPSCs and ESCs are indeed quite similar. The finding should boost those who advocate further use of iPSCs as an ethical alternative to embryonic stem cells.

Joshua Coon, an associate professor of chemistry and biomolecular chemistry, directed a study of four iPS cells and four embryonic stem cells and found a 99% similarity between the two. "We looked at RNA, at proteins and at structures on the proteins that help regulate their activity and saw substantial similarity between the two stem-cell types," Coon tells R&D Magazine.

The reason scientists are just getting around to doing this comparison now is the technology has improved to the point where they can get a more accurate reading of a protein's mass, Coon says. Still, this study is not the end of the story. While iPSCs and ESCs have been found to be similar, there need to be more studies comparing protein production after the cells are differentiated into, for example, a heart muscle cell or a neuron.

- read more in R&D Magazine
- and the abstract in Nature Methods

Virus sent on seek-and-destroy mission against cancer

2011-09-06T21:15:13Z

Drug-delivery technology is all about selectively killing disease while leaving healthy cells alone. Turns out, you can engineer a virus to do the same thing, according to a report in Technology Review. In an early-stage trial, 23 patients with metastatic cancers were injected with a new type of cancer-killing virus. Half of the patients saw their tumors stop growing, and a tumor even shrank in one patient. The results appear in the journal Nature.

The study seems to confirm viruses can selectively target cancer cells. The study was funded by Jennerex, a San Francisco biotech, which set out to find a virus that does not need to be injected directly into tumors, but can travel through the bloodstream on a seek-and-destroy mission. The result was JX-594, which is a strain of the vaccinia virus armed with GM-CSF, which triggers an immune attack against cancer cells. They also added a marker protein to track the virus's replication, Technology Review reports.

The effect, Jennerex CEO David Kirn told the magazine, was "a product that destroys tumors by multiple, complementary mechanisms." The technology is being tested in larger trials and recently completed a successful trial for liver cancer.

- read the report in Technology Review
- and the abstract in Nature

Martin Green: Give patients 'choice' over when they die

2011-08-28T16:55:52Z

Adviser says terminally ill patients should receive help to die.

Paralysed man who wants to die in Swiss suicide clinic brings British court test case

2011-08-18T19:04:03Z

A test case brought on behalf of a disabled stroke victim could clear the way for the establishment in Britain of suicide clinics like Dignitas in Switzerland (pictured)

Doctors Using Stem Cells to Treat MS

2011-08-29T14:49:17Z

Multiple sclerosis affects about 2.5 million people worldwide – and the disabling disease, which affects the body’s central nervous system – has always been irreversible

2010 law protects British docs, nurses against helping with abortion

2011-08-16T21:33:20Z

Author:

By Simon Caldwell Catholic News Service

MANCHESTER, England (CNS) -- A 2010 law is providing conscience protections for health care professionals in England who believe in "the sanctity of life from conception onward," regardless of their religious beliefs.

The Thomas More Legal Centre, which specializes in religious discrimination law, recently successfully defended two Catholic nurses who had asked not to be assigned to care for women at a central London hospital who were undergoing chemically induced abortions.

ZENIT - Pope's Address to Youth With Illnesses and Disabilities

2011-08-23T16:03:48Z

Is Suffering-Stricken Life Still Something Grand?

2011-08-20T04:00:00Z

MADRID, Spain, AUG. 20, 2011 (Zenit.org).- Surrounded by the smiles of mentally and physically handicapped youth, Benedict XVI today affirmed that life is grand, even when afflicted by suffering.

Stem cell science firm wins £100k Government cash

2011-08-07T22:46:40Z

Cell Guidance Systems, a stem cell tools company based in Cambridge UK, has been awarded £100,000 grant funding to pursue cutting edge technology in the field.

Group launches program to develop drugs for pediatric HIV

2011-07-18T16:35:43Z

The Drugs for Neglected Diseases Initiative (DNDi) has launched a new drug development program to address treatment needs of children with HIV. While developed countries can claim victory in virtually eliminating HIV infection in children due to effective prevention of mother-to-child transmission, there is little market incentive for pharmaceutical companies to develop antiretroviral drugs specifically for children in developing nations. This is why DNDi exists.

DNDi was launched in 2003 by research organizations around the world to develop medicine for diseases that impact the world's poor and fall through the cracks of R&D efforts of Big Pharma. The group is developing new treatments for malaria, visceral leishmaniasis, sleeping sickness (human African trypanosomiasis, HAT) and Chagas disease. Now, they're adding pediatric HIV to the list.

"There are millions of children with HIV/AIDS in low- and middle-income countries, but their needs are absent from the HIV research and development agenda, and this is largely because they are poor and voiceless and do not represent a lucrative market," Dr. Bernard Pécoul, DNDi's executive director, said in a statement. "Working with partners, we hope to help fill this terrible gap and offer improved treatment options for children with HIV/AIDS."

According to the DNDi release, the World Health Organization recommends immediate antiretroviral therapy (ARV) for all HIV-positive children less than two years old. The problem, though, is that nobody has established safe dosing guidelines for use of ARV in very young children. "Current pediatric ARV formulations are unpalatable for these children, are impractical for caregivers due to multiple liquid preparations that have to be adjusted according to weight, and have undesirable interactions with tuberculosis (TB) drugs," the release said.

DNDi's first priority will be to develop an improved first-line protease inhibitor-based regimen for children under three years old.

- read the DNDi release
- and listen to a related podcast

Special Report: Successes, failures mark 30 years of HIV/AIDS research

'Let woman with brain damage die'

2011-07-19T14:01:46Z

The sister of a severely brain-damaged woman has told a judge that she would not have wanted to live a life totally dependent on others.

New technique boosts efficiency of blood cell production from human stem cells

2011-07-15T15:50:01Z

Scientists at the Salk Institute for Biological Studies have developed an improved technique for generating large numbers of blood cells from a patient's own cells. The new technique will be immediately useful in further stem cell studies, and when perfected, could be used in stem cell therapies for a wide variety of conditions including cancers and immune ailments.