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Health Buzz: Tumors After Stem Cell Injections and Other Health News

admin — Tue, 10 Feb 2009 12:30:12 +0000

, according to a new report in the journal
. The child had a rare, deadly brain disease called ataxia telangiectasia, or A-T. The disease can lead to degeneration of a region of the brain; most people with A-T die by their teens or early 20s. The boy had traveled to Russia at age 9, when he was injected with fetal neural stem cells in his brain and spinal cord, the Associated Press reports. He received two additional sets of injections at ages 10 and 12. By age 13, the boy needed a wheelchair for his A-T, and he was experiencing headaches. The tumors in his brain and spinal cord were discovered soon after that. A test of the tissue found that the tumors were caused by the fetal cells.
Treatments involving stem cells, such as a
, are still viewed as experimental, yet some researchers believe they may help certain medical problems. Consider these
for certain diseases. Also, human stem cells now can be
, without using embryos or eggs.
Electronic Medical Records: Will Your Privacy Be Safe?
Electronic medical records have become a national goal, a way to
used in most medical settings today, Bernadine Healy reports. President Obama has made revamping the medical system a top priority, with the national electronic medical record first up in healthcare reform. Indeed, the economic stimulus package assigns billions of dollars to that effort. In light of public sensitivity, this major jump-start for centralized records comes with provisions to further strengthen privacy laws.
While electronic medical records are being touted as part of the key to an efficient healthcare system in the future, some doctors have been
.
Stressed Out? Find a Great Deal at a Spa
is not a word that traditionally has been associated with the spa industry. Yet, people looking for relief from the stress brought on by their shrinking portfolios will find that spas nationwide are
, Lindsay Lyon reports. “I’ve been in the spa industry 30 years, and I have never seen so many deals and so many good deals . . . unprecedented deals,” says Susie Ellis, president of SpaFinder.com, a website that helps people research and book visits at more than 5,000 day, resort, and destination spas worldwide. Many vacation spas, Ellis says, are lowering room rates, tossing extra services or meals into their overnight packages, allowing a free guest, or slashing the package price of midweek stays, for example.
Looking for an escape? Here are
at spas around the country. If visiting a spa isn’t in your budget, check out these
.
—January W. Payne
rom USNews.com
Need Care? Scan the Rankings:

Mo. groups' response to FDA stem cell decision mixed

admin — Thu, 11 Dec 2008 02:48:55 +0000

.
Dr. Steven Teitelbaum, a pathology and immunology professor at
, said scientists there were enthused about the prospect of advancing research with embryonic stem cells but also shared a word of caution about expectations.
“We want to see the promise of this therapy move forward,” he said Friday. “But we have to be careful about expectations. This is not a clinical trial to test whether embryonic stem cells will work therapeutically. This won’t make people get out of their wheelchairs. This is to determine only the safety of embryonic stem cells,” he said.
in Menlo, Calif., move forward with the world’s first study of a human embryonic stem cell based therapy in humans. Geron (NASDAQ: GERN) stock shot up about 50 percent Friday on the news.
“This is a good day for Missouri and our great research institutions like the University of Missouri, Washington University and the
” in Kansas City, said Missouri Attorney General Chris Koster in a statement. “But more importantly, it is a day of hope for all those who suffer from diseases that stem cell research might someday cure.”
The results of this first trial will have an impact on if and when St. Louis scientists will use stem cells to develop new drugs or to further research into genetic testing, said Teitelbaum, who studies bone diseases and osteoporosis.
Ed Martin, president of the
, said he wasn’t surprised by the decision given President Barack Obama’s support of stem cell research.
“But I am disappointed that Obama is moving so quickly,” he said.
for a state constitutional amendment that would ban the use of tax dollars for embryonic stem cell research, abortions and human cloning.
The study focuses on spinal cord injuries, but people with cancer, diabetes, heart disease and other afflictions should take note because scientists are exploring whether embryonic stem cells could treat those diseases, too, said Jim Goodwin, spokesman for the
.

FDA Accepts Cell Therapeutics' Zevalin sBLA and Grants Priority Review

admin — Sun, 23 Nov 2008 09:04:40 +0000

This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of Zevalin include risks
associated with preclinical and clinical developments in the biopharmaceutical
industry in general and with Zevalin in particular including, without
limitation, the potential for Zevalin FIT data to be acceptable to the FDA for
this expanded indication or any other indication, the determinations by
regulatory, patent and administrative governmental authorities, competitive
factors, technological developments, and costs of developing, producing and
selling Zevalin, whether the new Joint Venture with Spectrum is completed and
the ability of CTI to continue to raise capital to fund its operations. There
is also a risk that even if label expansion of Zevalin is approved, it may not
result in a significant market increase for the drug due to the presence of
other treatment options, failure to gain market acceptance and other factors.
You should also review the risk factors listed or described from time to time
in the Company’s filings with the Securities and Exchange Commission
including, without limitation, the Company’s most recent filings on Forms 10-
K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to
update or alter its forward-looking statements whether as a result of new
information, future events, or otherwise.

Stem Cell Research Moves Forward

admin — Tue, 11 Nov 2008 01:55:34 +0000

Induced pluripotent stem cells are derived from an adult stem cell using genes and viruses. Researchers have tried to improve this method by developing a safer way to obtain stem cells from adult cells without using the viruses that can cause cancer. Last year, researchers at the Massachusetts General Hospital and Harvard Medical School in Boston managed to reprogram adult skin cells into embryonic-like stem cells using adenoviruses which don’t integrate into the genome, preventing the genetic alteration of the cell.

Koster praises FDA decision to allow stem cell trial

admin — Tue, 04 Nov 2008 11:34:06 +0000

JEFFERSON CITY, Mo. (Legal Newsline)-Pointing to his father’s battle with diabetes, Missouri Attorney General Chris Koster praised the Food and Drug Administration’s decision to allow testing using human embryonic stem cells.
“As the son of a man who battled diabetes, I believe stem cell research is an important channel to fight disease,” Koster said in a statement.
Last week, the FDA gave a green light to Menlo Park, Calif.-based biotechnology company Geron Corp. to conduct the first-ever trial of embryonic stem cells on humans.
For the trial, 10 patients with spinal injuries will be injected with human embryonic stem cells to help determine if the cells can safely help nerve tissue grow. If successful, the research may lend itself to treatments for other debilitating diseases, such as Alzheimer’s, Parkinson’s, Type 1 diabetes and multiple sclerosis.
“This is a good day for Missouri and our great research institutions like the University of Missouri, Washington University and the Stowers Institute,” Koster said Friday, when the Phase I clinical trial was announced. “But more importantly, it is a day of hope for all those who suffer from diseases that stem cell research might someday cure.”
President Barack Obama has been widely expected to lift Bush-era restrictions on federal funding and support of human embryonic stem cell research. Former President George W. Bush opposed stem cell research, saying the technology requires the destruction of human embryos.
Observers say the FDA’s announcement had nothing to do with Bush leaving office.

Juxtaposed Nations: FDA wrongly permits embryonic stem-cell research

admin — Sun, 28 Sep 2008 14:48:30 +0000

The FDA recently permitted Geron Corp., a biotech company in California, to test embryonic stem cells in human patients for the first time.
Apparently deciding to forego the numerous ethical and safety concerns associated with this practice, the FDA gave Geron the green light the same week President Barack Obama was inaugurated. This is undoubtedly a sample of the “change” we have been promised.
Geron should abandon the limelight in favor of patient safety. Possible tumor formations and the need to place their patients on anti-rejection drugs are both dangerous risks that are not worth the modest results the tests will yield.
But it seems the only risk Geron is concerned with is the possibility that embryonic stem cells may be merely equal, or perhaps lesser, than their counterparts — adult stem cells.
Adult stem cells are often overlooked as an alternative to embryonic stem cells.
The two are similar in function, but adult stem cells are taken from areas including the wisdom teeth, brain, bone marrow and liver and can only re-grow tissue in the area they were taken from.
This means adult stem cells can be harvested as needed, assuming they are accessible. Contrary to embryonic cells, adult cells do not require anti-rejection drugs because they are usually taken from the patient’s own body.
Given that Geron Corp. has abandoned the moral alternative adult stem cells offer in favor of the ethically obscure and largely untested, one can’t help but wonder if they were simply motivated by patent money rather than scientific progress.
Most of the leverage proponents of embryonic stem cell research have gained is based on the argument that many embryos left over from in vitro fertilization — a form of artificial insemination — are slated by their parents to be destroyed anyway.
To sidestep this argument, something must be done to reduce the amount of leftover embryos.
The obvious answer is to impose IVF regulations. Not only would this lower health risks for the patients, it would help them avoid grappling with morally ambiguous questions and nasty custody battles that sometimes occur when couples separate, leaving frozen embryos in limbo.
New technology has streamlined the IVF process, making regulation possible.
Researchers at Stanford University of Medicine conducted a study last July and discovered by looking at several different factors in their patients such as age, hormone levels, egg quality and embryonic characteristics, they could predict a pregnancy with a 70 percent accuracy rate.
After an initial test cycle, doctors used this information as a reference point to adjust the amount of embryos created in the process according to the patient’s fertility, thereby reducing extra embryos every cycle.
A study conducted five years ago at Sahlgrenska, a Swedish academy, discovered another reduction method.
The findings reveal the success rate of multiple implants doesn’t significantly exceed that of a single implant, thus eliminating any need for extra embryos — or excuses to create them.
These methods can reduce the chances of having high-risk pregnancies, save patients money by predicting pregnancy rates, improve health and eliminate the stress of answering the question above Obama’s pay grade.
Quite frankly, no one has the authority to answer that question to satisfaction — the FDA included. Perhaps they should have remembered that, before considering themselves the authority on what constitutes the exact moment of commencement of life.
Though this moment may never be determined beyond doubt, human life is not something to gamble with.
It should always be given the benefit of the doubt, not exploited for scientific advances that are uncertain at best.
Contact Linnie Leavins at lleavins@lsureveille.com

Cell Therapeutics: pixantrone to be submitted for FDA approval in NHL

admin — Sun, 21 Sep 2008 10:43:20 +0000

Jan 27, 2009 (Datamonitor via COMTEX) –
— Following discussions with the FDA, Cell Therapeutics will attempt to secure approval of pixantrone in relapsed aggressive non-Hodgkin’s lymphoma before the end of 2009. Given the lack of a therapeutic standard within this indication, pixantrone’s chances of approval are high.
Cell Therapeutics expects to begin submission of a rolling new drug application (NDA) for pixantrone in the first quarter of 2009. The rolling NDA will be based on results from the Phase III EXTEND trial, which evaluated the drug in patients with relapsed, aggressive non-Hodgkin’s lymphoma (NHL) who had received two or more prior therapies and were sensitive to treatment with anthracyclines. The 140 patients were randomized to receive third-line pixantrone or another standard single-agent drug, such as ifosfamide, etoposide, mitoxantrone, Gemzar (gemcitabine; Eli Lilly) or Rituxan (rituximab; Biogen Idec/Genentech/Roche). The EXTEND trial achieved its primary efficacy endpoint, with patients in the pixantrone arm achieving a high rate of complete remissions (20.0%) compared with patients treated with standard chemotherapy (5.7%).
Pixantrone is a second-generation anthracenedione analog that inhibits topoisomerase II. It is structurally similar to anthracyclines such as doxorubicin, but is modified to improve efficacy and reduce toxicity. Pixantrone received fast track status from the FDA for aggressive NHL in July 2004, and for relapsed or refractory indolent NHL in May 2007.
In 2007, the incidence of NHL in the seven major markets was 122,120, with the disease being most prevalent in the US. Aggressive NHLs include diffuse B-cell and mantle cell lymphomas, which collectively account for 47% of the total patient population. With no current standard of care, patients with relapsed, aggressive NHL represent an underserved patient population.
In light of the high unmet need in the third-line setting of advanced, recurrent NHL, pixantrone’s chances of approval are high, representing a potentially successful market entry strategy for Cell Therapeutics. Nevertheless, in order for pixantrone to realize its full commercial potential, Cell Therapeutics will have to consider expansion into additional treatment settings because the target population is low. About 50% of patients suffering from aggressive NHL are cured after first-line treatment with Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (RCHOP). While competition from cheaper generic alternatives may be higher in earlier treatment settings, a strategic pricing strategy may help Cell Therapeutics realize an acceptable return on pixantrone’s development costs.

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American Medical Association calls all states to pass cell phone laws

admin — Tue, 16 Sep 2008 22:49:42 +0000

AMA asks all state lawmakers pass laws limiting driver cell phone use. National doctors organization urges states to protect consumers from injury and death.
December 23, 2008, West Palm Beach, FL (JusticeNewsFlash.com)–Justice roadway safety advocates and West Palm Beach auto accident lawyers are joining the American Medical Association’s (AMA) http://www.ama-assn.org/ ban against text messaging while driving initiative. In early November 2008, the AMA issued a public health risk alert at its semi-annual policy-making meeting. AMA voted to advocate for state legislation prohibiting the use of hand-held devices to text message while driving affirming it is a public health risk.
JNF roadway and highway safety advocates report the AMA states text messaging while driving takes the driver’s attention away from the road and this leads to accidents. The AMA sites a recent study reflects text messaging while driving causes a 400% increase time spent with eyes off the road. American drivers and passengers should not have to be concerned that other drivers are focused on texting instead of traffic.
Justice reporters also learned the new AMA policy encourages physicians to educate patients on the public health risks associated with driving while distracted with text messages and cell phones. The AMA is supporting any state legislature enacting laws to eliminate the use of text messaging by motorists while driving. If you or someone you know has been injured by a driver too busy text messaging you may be entitled to compensation.
News Contributor: H. Ryan highway safety advocate reporting for Justice
JNF–JusticeNewsFlash.com gives lawyers, journalists, and other professionals the opportunity to provide breaking news to their communities using an easy to access, convenient medium. Top news stories include driver cell phone use injury cases, text messaging while driving wrongful death litigation, SUV rollover accident suits, car crash claims, truck wreck injury legal actions, personal injury court cases, and driver negligence court actions.
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– JusticeNewsFlash.com

FDA Approves World's First Embryonic Human Stem Cell Trial

admin — Thu, 11 Sep 2008 14:40:17 +0000

Using stem cells is controversial because embryonic stem cells are taken from human fetuses.
Earlier this month, Glasgow researchers were planning a “major trial” to test the
, according to the BBC. The United Kingdom approved the trial after the US Food and Drug Administration rejected the proposal from ReNeuron, the company that developed the therapy, two years ago.
According to Medical News Today, “
. However, the rest either die or become disabled for life. The only therapy that can help those permanently disabled is physiotherapy (physical therapy).”
The scientists will inject cells made from a human fetus into the brains of their patients, hoping that the “cells will regenerate areas damaged by stroke, and increase patients’ movements and mental abilities,” the BBC writes. The trial is scheduled to begin next year and will, at first, follow four groups of three patients over two years.
Anti-abortion groups have opposed the trial, and the Society for the Unborn Child even called the proposal “sick.” A spokesperson for the organization claimed that, “It involves cannibalising an unborn child,” according to the BBC.
Recently, medical experts announced that a two-year trial will begin this month on the
, according to Agence France-Presse. The experiment, which will take place at Princess Alexandra Eye Pavilion in Edinburgh and the Gartnavel General Hospital in Glasgow, is not as controversial as the stroke trial because it involves stem cells from dead adult donors instead of embryonic stem cells.
Several recent medical breakthroughs have involved adult stem cells. In November 2008, Bloomberg reported that five months after doctors in Spain gave Claudia Castillo, 30, a
, her lungs were working normally for a person her age.
Another experimental procedure uses a person’s own stem cells to fix meniscal cartilage tears in the knee. In 2007, another research team said it was able to reprogram human skin cells to act like embryonic stem cells, or cells that can turn into any type of human tissue.

Abbott Receives FDA Clearance for New CELL-DYN® Emerald …

admin — Mon, 08 Sep 2008 02:36:14 +0000

CELL-DYN Emerald Designed to Deliver Quick, Reliable Results for Small to Mid-Sized Laboratories
Abbott Park, Illinois (
) — Abbott today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new, compact hematology instrument, CELL-DYN Emerald™. Abbott’s CELL-DYN Emerald will expand the company’s hematology platform by offering a high performance, affordable solution for small to mid-sized clinical laboratories.
As small to mid-sized hospital laboratories and clinics continue to seek greater efficiency and productivity under tighter space limitations, Emerald’s small size, touch screen software, and reliability offer an easy-to-use, compact table/bench top instrument for performing complete blood counts (CBCs), a test routinely ordered by doctors to assess a patient’s overall health and to screen for a variety of disorders such as anemia and infection.
This new hematology system has many automation features designed to save laboratories’ time, allowing them to improve productivity and reduce costs. Time saving features of Abbott’s CELL-DYN Emerald include:
* A full touch-screen monitor to simplify operation.
* One-button startup.
* Low reagent consumption.
* Automatic cleaning and shutdown features.
* Barcode labeled reagents.
A key facet of CELL-DYN Emerald is its compact size — weighing just 9kg (less than 20 lbs) — as well as its intuitive software interface that allows for easy navigation and quick results. With Abbott’s Emerald, CBC results are completed in 60 seconds and reported in an easy-to-read format with histograms representing white blood cells, red blood cells and platelets.
“As hospitals and clinics try to do more, faster and in less space, Abbott’s CELL-DYN Emerald offers a compact, fast, reliable analyzer to support the hematology testing needs of many small to medium-sized hospital laboratories and clinics” said Mike Warmuth, senior vice president, diagnostics, Abbott.