Posted on

* If You Can’t Get an Organ, an Organoid Might Do

http://gizmodo.com/5851454/if-you-cant-get-an-organ-an-organoid-might-do

Oct 19, 2011

If You Can’t Get an Organ, an Organoid Might Do

The line waiting for organ donors is 112,381 people long and growing, and 18 people daily die waiting. To help patients survive the interim, scientists are working on “organoinds”—mini organs that would temporarily operate outside the body.

Dr. Rober Hariri, a surgeon and CEO of Celgene Cellular Therapeutics, is using stem cells derived from placentas (a refreshingly non-conroversial source of stem cells), to build the temporary organs. He devised a method for implanting the stem cells into a tissue matrix made from cells taken from cadavers. If the matrix is made of, say, kidney cells, the stem cells will take cues from their environment and also transform into kidney cells.

Full size

 
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The drawing depicts stem cells being extracted from a placenta.

The resulting glob is a mini-organ that could temporarily perform the functions of a failing human liver, kidney, heart, and possibly any other human organ. The patients’ blood would be filtered through the organ through tubes.

“This could be the way we build replacement parts,” Hariri said.

You can check out their patent here. Hariri will talk more about his progress with organoids at the Tissue Engineering and Regenerative Medicine Society annual meeting in Houston in December.

[Images: Celgene, US Patent 7914779]

Posted on

* 50 Marathons 50 States | 10/14

http://www.ctnow.com/videobeta/01438568-9708-430b-8687-5edea2adf7a2/News/50-Marathons-50-States-10-14

Don Wright, 70, is It is said to practice the medicine twice in a day as it can turn out to be strong, effects seen within 3 cialis order to 6 months. Don’t mix them with alcohol, nicotine, caffeine and other stimulants may be risky. buy generic cialis For example, my former husband finally quit smoking viagra sans prescription canada when his physician gave him this choice. “You quit or you die.” He made the right choice and is enjoying life. ESSENTIAL INFORMATION- Before taking online viagra any specific medicine a person should completely know about its uses. running a marathon in every state to raise money for cancer. Hartford will be his 39th run.

Posted on

* 70-year-old battling cancer completes 56th marathon

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Written by Kristin DiCara


PORTLAND, Maine (NEWS CENTER) — Among the thousands of runners who ran in the Maine Marathon, one 70-year-old runner was running for a cause very close to him.

Don Wright suffers from Myeloma, an incurable form of blood cancer.  When he was diagnosed in 2003, he set out to run a marathon in each of the 50 states.  The Maine Marathon is his 56th marathon in his 38th state. Wright is running for Team Continuum, a non-profit that raises money to help cancer patients and their families pay their bills.  His campain slogan is his goal: to “E-Race Cancer”.

“I like to think sometimes as I’m running along that I’m just sticking it right in the cancer’s eye,” Wright said.

Team continuum has a Facebook page, and for every “like” the page receives, $5 will be donated to the non-profit.

NEWS CENTER

Posted on

* He has every reason to run

September 30

He has every reason to run

By Glenn Jordan gjordan@mainetoday.com
Staff Writer

Don Wright received his cancer diagnosis the same month as his first marathon medal.

click image to enlarge

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Don Wright

At the time, Wright was 62. Patients with myeloma, a blood cancer that affects cells in the bone marrow, could expect an average of another five years of life.

For Wright, that was eight years and 54 more marathons ago.

He plans to go after No. 56 Sunday morning at the Maine Marathon and Half Marathon, which starts and finishes near Back Cove in Portland.

“I’ve been given extra years of life,” Wright said Thursday while on his way east from his home in Minnesota. “I feel like I need to do the best I can with them, to make it an active and enjoyable life.”

Wright, 70, will be one of approximately 3,500 runners heading north on Route 1 Sunday morning in the 20th edition of the event. About 2,300 will turn around on Route 88 in Falmouth and head back to Portland to complete a half marathon. About 1,200 will continue through Cumberland Foreside to Yarmouth before looping back to Back Cove.

The main beneficiary from this year’s event is Camp To Belong Maine, an organization that brings together siblings separated by foster care or other out-of-home care.

A host of other charities use the Maine Marathon to raise money, most notably the Leukemia and Lymphoma Society’s Team in Training Program.

Since 1997, participants in the Maine Marathon, Half Marathon and Relay have raised more than $2.6 million.

Wright is running for Team Continuum, a nonprofit dedicated to helping cancer patients and their families with immediate, vital, nonmedical financial assistance. His campaign is called E-Race Cancer and for every “like” on his campaign’s Facebook page, sponsors will donate $5 to Team Continuum.

A mostly retired computer consultant and lawyer whose treatment consists of a daily pill that doesn’t cure his myeloma but helps keep it in remission, Wright tries to eat only organic food.

His wife Ardis and daughter Sarah will accompany him to Maine. Both plan to run the half marathon.

Wright hadn’t run regularly since high school before taking it up again after turning 60.

“I just wanted to lose weight and be healthy and strong,” he said. “Then when I got into it, I found that I really enjoyed it.”

He built up to marathon distance with the goal of qualifying for Boston. It didn’t happen that first marathon, but he qualified later the same year and ran the 2004 Boston Marathon.

His best time was 3 hours, 36 minutes at the 2006 Twin Cities Marathon when he was 65. As the marathons piled up, he started thinking about joining the 50 states club. That, and a conversation at a hematology conference last winter, led to the fundraising campaign.

Two weeks ago at a marathon in Erie, Pa., Wright checked off his 37th state. Maine will be 38. His upcoming schedule includes Hartford, Conn. (Oct. 15), Washington, D.C. (Oct. 30) and the New York City Marathon (Nov. 6).

“I feel like I’m a very lucky beneficiary of recent research and development in cancer medications,” he said. “We certainly are spending a lot of time enjoying the life that we have. As you can tell, it’s a very active life.

Staff Writer Glenn Jordan can be contacted at 791-6425 or at:

gjordan@pressherald.com

Twitter: GlennJordanPPH

Posted on

* Turning Point: Cancer diagnosis hasn’t slowed down dedicated marathoner from Lake Elmo

St. Paul Pioneer Press

9/16/2011

Turning Point: Cancer diagnosis hasn’t slowed down dedicated marathoner from Lake Elmo

http://www.twincities.com/ci_18903940?IADID=Search-www.twincities.com-www.twincities.com

By Rhoda Fukushima

Don Wright (Debra Gendel)

Don Wright of Lake Elmo ran his first marathon, Grandma’s Marathon, in June 2003. That month, he also was diagnosed with multiple myeloma, cancer of the plasma cells in bone marrow. Since then, Wright, now 70, has run 54 marathons in 36 states. He wants to do a marathon in every state. Today, Wright plans to run the Erie Marathon in Pennsylvania.

“I wasn’t expecting cancer at all. My family doesn’t have much cancer. When I got the diagnosis, I was scared. But I felt good. It was easy to be in denial, and I was, at first.

“After the initial shock, my reaction was to see if I could qualify for and run the Boston Marathon in 2004. I ran eight 20-mile runs between Grandma’s Marathon (in June) and Twin Cities Marathon (in October). I had qualifying times for Boston twice – at the Twin Cities Marathon and at the Tucson Marathon in December 2003.

“The doctor was totally supportive of my running. He believed it would strengthen my bones. I believe that, too.

“At that point and even yet, the myeloma hasn’t caused any symptoms. It was caught at an early stage. It was two more years before we started treatment.

“I started taking Thalomid. It didn’t do anything but give me a rash. I tried the supplement curcumin, but it didn’t do any good.

“In March 2008, my doctor put me on an experimental drug called pomalidomide. I have been stable ever since. I take that pill every night before I go to bed.
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“When I ran my first marathon, I was thinking, ‘Why on earth would anyone do this?’ It’s a lot of hard work and pain. When I got across the finish line, I knew I would be doing another one.

“Running is emotional, spiritual. Something just draws me to that long run. When I’m running, my mind is free to roam. I can just sort of float across the ground. I love that feeling.

“A friend of my dad’s once told me, ‘I was always ready for a marathon.’ I liked that sentiment. Now, I am always in marathon-ready shape.

“We do this as a family. My wife and daughter run either the marathon or half-marathon. That’s part of the joy.

“I train on the Gateway Trail, and we recently discovered the Lake Elmo Park Reserve. We enjoy running on the trails. This is the time of year to run in the park.

“I like to run when it’s cool. In summer, that means morning runs. In winter, we often go to the Stillwater Dome and run on the indoor soccer track. I’ve run a 20-miler in there. It’s not the most enjoyable thing, but it gets the job done.

“We are very careful about what we eat. We avoid gluten because there is some indication gluten can affect some myeloma patients in a negative way. We also buy organic food.

“I deal with injuries all the time. Name a runner’s injury, and I’ve had it. Sometimes, we have to take time off. Right now, I’m fighting a little injury, a pulled muscle in my abdomen. I’ve been going to the health club to run on the elliptical machines.

“We get to races at least one day early. We try to drive the race course and get a feel for the community. We’ve learned a lot of geography.

“My myeloma is stable. When I was diagnosed, the median survival time was eight years. Now, the median survival time has increased greatly because of new drugs.

“I feel great. Life is good.”

Posted on

GT answers FDA questions for LuViva PMA application

GT answers FDA questions for LuViva PMA application

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=76690

By AMANDA PEDERSEN

September 6, 2011

Medical Device Daily Senior Staff Writer

Guided Therapeutics (Norcross, Georgia), a developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, says it has answered all of FDA’s key questions regarding the company’s premarket approval (PMA) application for the LuViva Advanced Cervical Scan.

“We are pleased to provide the FDA with the additional information the agency requested and within the time period required to maintain the PMA application under active review,” said Mark Faupel, PhD, president/CEO of Guided Therapeutics. “The FDA will review our submission, we hope move forward with the PMA process and schedule a panel meeting date, although the agency has the option to ask for additional information.”

LuViva scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively, the company noted. Guided Therapeutics’ biophotonic technology is designed to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, LuViva does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly and painful unnecessary testing, the company said.

Faupel told Medical Device Daily that the sequence of events with FDA so far has followed a “normal” track. “There are a number of people at FDA involved in formulating questions both with regard to the clinical side of the clinical trial and technical side of the instrumentation,” he said. There were several questions the company had previously dealt with by submitting draft responses and the majority of those were accepted on what Faupel referred to as a “first round.” There was one question, however, that the agency asked for additional information on which Guided Therapeutics says has now been dealt with. He declined to say what that issue was for competitive reasons. Now the company just has to wait and see if and when a panel meeting is scheduled.

“It was a necessary and major step in getting us closer to that panel meeting,” Faupel said.

The company submitted its PMA application about a year ago (Medical Device Daily, Sept. 28, 2010). In its pivotal trial, more than 1,600 women at risk for cervical disease were tested with the device. According to the company, the device detected cervical disease up to two years sooner than a Pap test, HPV test, colposcopy or biopsy and it detected 86.3% of cervical disease cases that had been missed by these other methods. Also, the device would have reduced the number of unnecessary biopsies by about 40%.
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The fact that the questioning phase of the process was so involved simply reflects that the company has a “fairly high visibility product with a lot of reviewers” involved, Faupel said. “They are more involved in the questions . . . leadership at FDA is very conscious now of the issues that have occurred in the past.”

While it waits for a panel meeting to be scheduled, Guided Therapeutics continues to make progress with its planned international launch and have orders in place with distributors for demonstration and clinical units for Europe and Asia, Faupel said.

“This is a product that we feel strongly will have a home not just in the U.S.,” Faupel told MDD. “It was designed to be low cost, easy to use, easy to train the user, [and] easy to interpret the results.”

Such features are what sets the technology apart from existing testing methods, he said.

“The current standard of care involves a lot of human interaction and data,” he said. He added that an initial PAP test, which requires a highly trained technician to interpret and that another test involving a magnified view of the cervix requires a well-trained physician to interpret and is subjective. “They all involve a lab delay to get a final answer, where as with our product you get a final answer at the point of care.”

The company was recently awarded $517,000 to fund the third year of a $2.5 million three-year grant from the National Cancer Institute (NCI). The grant provides additional resources to help commercialize and bring the LuViva to market. The company has been awarded more than $6 million in six consecutive grants from the NCI to develop the new test for detecting cervical disease since 2001 (MDD, Aug. 26, 2011).

In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports.

The company has also entered into a partnership with Konica Minolta Opto (Tokyo) to develop a non-invasive test for Barrett’s esophagus using the technology platform.

“This is a platform technology and we believe it can be utilized to detect nearly 90% of all cancers in the body,” Faupel said.

In fact, the company has already begun human testing of its light-based technology for Barrett’s Esophagus, a precursor for esophageal cancer. The feasibility study is designed to test the concept of using the platform for the detection of changes in esophageal tissue. The study also tests various hardware and procedural configurations and is designed to determine a way forward for product development and further clinical trials. The feasibility study is expected to enroll about 40 subjects and be completed before the end of the year. It is being conducted at two Atlanta-area clinics (MDD, Aug. 11, 2011).

Posted on

U.S. Stem Cell Companies Find Partners and Revenues Beyond the Water’s Edge

http://www.genengnews.com/analysis-and-insight/us-stem-cell-companies-find-partners-and-revenues-beyond-the-water-b-b/77899444/

Analysis & Insight : Aug 16, 2011

U.S. Stem Cell Companies Find Partners and Revenues Beyond the Water’s Edge

Firms find it easier to navigate regulatory requirements in Asia as well as Europe.

  • Alex Philippidis

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American companies focused on stem cell treatments and technology platforms have met with success in finding partnerships and revenues overseas in the past decade. And it’s not for the reason many people might think, namely the controversy over U.S. federal funding of human embryonic stem cell (hESC) research.

Two other factors better explain why U.S. stem cell companies have been looking beyond their borders to Asia, according to Bernard Siegel, founder and full-time executive director of the nonprofit Genetics Policy Institute (GPI).

One is the attractiveness of Asian countries as markets for stem cell treatments. That reflects both high population concentrations as well as willingness by national governments to invest in stem cell research as well as companies commercializing such treatments and encourage additional research by outside parties. The other is Asia’s lower regulatory hurdles when compared to the U.S.

“It’s easier to move toward the translational process and get clinical trials cranked up in Asia than the United States,” Siegel pointed out. “I think that’s one aspect of it.”

U.S. companies can do that and more in Europe as well, if one company’s experience is any indication. Cytori Therapeutics has won both initial and expanded indication approval in Europe for its Celution® System family of medical devices and instruments, which is not yet available in the U.S. Celution extracts and separates stem and regenerative cells from a patient’s own adipose tissue.

“What we found as we moved through the European market is that that head-start was really important relative to the U.S. or other places,” Cytori president Marc H. Hedrick, M.D., told GEN.

Japan’s Position

The initial European approval allowed Cytori to expand into Japan where, Dr. Hedrick noted, the company obtained its first clinical experience. The company capitalized on the fact that doctors in Japan can, with a prescription, import technologies approved elsewhere.

“And it just so happened we had a relationship with one of the preeminent surgeons in Japan. In fact, our first 20 patients had breast cancer reconstructions performed in Japan at his university hospital,” Dr. Hedrick recalled.

“At the same time, we identified someone to lead the charge in Japan, that we were very fortunate to get, who was a business leader at Baxter in Japan. One thing led to another, and we now have the majority of our revenues from Japan. And it was all tied back to that original regulatory approval in Europe that allowed us to get into that market very quickly,” Dr. Hedrick added.

Japan’s share of Cytori’s sales tumbled during the first quarter to 30% from 72% a year earlier due to the March 11 Tohoku earthquake and resulting tsunami. Japan is where Cytori, which maintains a Tokyo office, found two investors among some of the country’s corporate giants. Last year Astellas agreed to buy $10 million of Cytori stock. And in 2008, Olympus, a medical device company, led a $17 million private placement financing. Two years prior Olympus made an $11 million milestone payment to Cytori for obtaining CE Mark approval for the original Celution system.

“They provided a significant amount of capital to Cytori, and that was another reason why it made sense to focus on the Japanese market,” Dr. Hedrick said.

Other Countries in Asia

Neuralstem is also involved in partnerships with Asian companies, with deals initially focused on research. While Neuralstem last year established a wholly owned subsidiary in China, it has yet to come to terms with commercial or regulatory collaborators.

By year-end the firm plans to start a clinical trial in China focused on transplantation of cells into the brain to treat stroke. The trial would take place at Beijing’s BaYi Brain Hospital, which has been working with Neuralstem to prepare a clinical protocol for treatment of motor deficits due to ischemic stroke.

In Japan the company came to terms with the wholly owned subsidiary of Sumitomo, Summit Pharmaceuticals, to market development and licensing rights for NSI-189, Neuralstem’s lead small molecule neurogenic compound. It is currently in an FDA-approved Phase I trial for major depression. The company has said it intends to take NSI-189 through Phase II trials before seeking a partner for worldwide rights.

Neuralstem has also entered into collaborations in Taiwan, including one with China Medical University & Hospital, to advance development of its human spinal cord neural stem cell therapies for amyotrophic lateral sclerosis. It is also working with the hospital to commence a clinical trial focused on treating stroke.

Additionally, in India, the company is planning a clinical trial for later this year to assess the ability of its cell therapy to treat spinal cord injury. The Indian market is so large that companies like Neuralstem need to find a technological partner first to ensure access to the best neurosurgeons it can find, according to Richard Garr, CEO. “We’re happy to do the proof of principle human studies ourselves before we look for a commercial and regulatory partner.”

Neuralstem notes that it has done most of its proof of principle collaborations with American universities such as the University of California, San Diego and the University of Michigan. “We haven’t gone overseas because we can’t do it here in the U.S.,” Garr remarked. “We went overseas because we believe those are their own independent markets.” Garr points out that commercialization efforts for each country are independent of each other.

“The other reason” to move into Asian countries, he added, “is because if you don’t, someone else will. And then you end up in a fight trying to protect it.”

Neuralstem broke into Asia in 2008, when Korean conglomerate CJ CheilJedang (CJ) bought $2.5 million worth of Neuralstem stock. CJ has an exclusive option to Neuralstem’s spinal cord cell products for five Asian nations: South Korea, Vietnam, Indonesia, Malaysia, and Singapore.

CJ would have the responsibility to take the products through regulatory approvals and commercialization in their markets. Garr expects CJ to decide what its first clinical trial will be and where later this year.

Another U.S. stem cell company that has teamed up with a Korean company is Advanced Cell Technology (ACT). In 2008, ACT joined with CHA Biotech to form a joint venture aimed at developing ACT’s hESC-based hemangioblast (HG) platform for the treatment of blood and cardiovascular diseases.

On July 21, the companies announced that their venture, Stem Cell & Regenerative Medicine International (SCRMI), exclusively licensed the rights to the HG program to ACT for the U.S. and Canada and to CHA Biotech for Korea and Japan.

“The partnership itself had research scientists working on trying to get things ready for starting human trials. And the way the deal works, ACT has hired substantially all the scientists that were working in the joint venture”—10 SCRMI employees in all, Gary Rabin, ACT’s interim chairman and CEO, told GEN.

Rabin said the first IND will be filed for using the HG platform to generate renewable sources of transfusable blood platelets. The platelets could unlock a significant opportunity for ACT, namely in the military wound-care market.

Last year, Robert Lanza, M.D., ACT’s CSO, and Kwang-Soo Kim, Ph.D., of Harvard University’s McLean Hospital and the CHA Stem Cell Institute, won a $1.9 million NIH director’s opportunity award to explore the potential of induced pluripotent stem cells (iPSCs) as a source of universal red blood cells and platelets for transfusion.

Another Asian market ACT is keeping an eye on is China. In March the company reported that China’s State Intellectual Property Office allowed its patent application to provide broad intellectual property protection for the manufacturing and pharmaceutical preparations of retinal pigment epithelial (RPE) cells from hESCs for degenerative retinal disease.

ACT has initiated a Phase I study with the RPE therapy in the U.S. Additionally, ACT has launched human trials for Stargardt macular dystrophy and advanced dry age-related macular degeneration. Data from those trials is expected to be published this fall, after the first three patients are tested in both trials.

Working in Europe

In Europe, Cytori won expanded approval for Celution last year. The sanction included new indications such as breast reconstruction, repair of soft tissue defects, as well as the facilitation of healing certain types of wounds such as those resulting from Crohn disease.

“We’re relatively close, we think, to getting approval for cardiac disease,” Dr. Hedrick added. “And we’re actually beginning to get reimbursement and working toward our own diagnosis-related group payments for the technology in Europe. So that series of decisions, predicated all on the early regulatory approval of the device, has really pushed us down the road of being very active in Europe.”

Cytori sees more potential partnerships among global medical device companies across Europe, particularly in Switzerland, where the company has an office in Zug. Neuralstem is collaborating with Albert-Ludwigs-University in Freiburg, Germany, on a treatment for Huntington disease. It also plans on undertaking a chronic spinal cord injury trial using spinal cord cells being developed at the Czech Institute of Experimental Medicine.

The ability of the European market to grow as a stem cell mecca will hinge, Siegel said, on the outcome of a pending court case that—while different on specifics—parallels the U.S. debate over hESC funding.

Later this year the Court of Justice of the European Union is expected to decide whether to side with its advocate general, who termed stem cell patents “contrary to ethics and public policy,” or with Oliver Brüstle, Ph.D., who since 2004 has fought to maintain a 1997 patent covering methods for deriving neural cells from hESCs despite a challenge from Greenpeace. Dr. Brüstle is director of the Institute of Reconstructive Neurobiology at the University of Bonn.

A decision against Dr. Brüstle would cement Asia’s place on the hESC end of stem cell research and commercialization. The U.S. remains schizophrenic, with President Barack Obama’s administration scrambling to approve new hESC lines, while the Sherley v. Sebelius court case and the nation’s political divide keep federal funding from being a certainty.

Yet all of that doesn’t necessarily hurt U.S. stem cell companies. As the past few years have demonstrated, they are perfectly capable of following the money and partners in pursuit of the science and show no signs of pulling back from their overseas activity.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

Posted on

Experiment seeks blood test for breast cancer

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News

Experiment seeks blood test for breast cancer

Tue, Mar 09 14:08 PM EST

http://us.mobile.reuters.com/mobile/m/AnyArticle/p.rdt?URL=http://www.reuters.com/article/idUSTRE6283XR20100309

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – An experimental approach that looks for the DNA leaking out from dead and dying cells may provide a route to a blood test for breast cancer, U.S. researchers reported on Tuesday.

An initial study showed the test detected 70 percent of breast cancer cases, and correctly cleared 100 percent of women who did not have breast cancer, the team at Chronix Biomedical, a privately-owned company in San Jose, California, said.

The experimental test is not ready to develop into a product but provides a basis for further research, they wrote in the journal Molecular Cancer Research.

“It is based on finding the unique DNA fingerprints from dead and dying cells,” Chronix CEO Howard Urnovitz said in a telephone interview.

Technological advances in DNA sequencing made the test possible, Urnovitz said. His team sequenced the entire genomes of 26 breast cancer patients and of 67 apparently healthy women.

They were looking for extra DNA in the blood of the breast cancer patients that would come from cells dying because of the tumors.

“If a breast cell is injured, it will overexpress the genes that make it a breast cell,” Urnovitz said. In theory, if a patient has excess DNA from breast cells that are dying, there is something going on that is killing breast cells.

The search is not easy. “The entire genome can be found in the blood,” Urnovitz said. And billions of cells die every day in the human body.

But eventually the Chronix team found what they believe is tell-tale DNA from dying breast cells.

“This study supports the potential of an entirely new approach to identifying cancer at its earliest stages when therapies may be most effective,” Dr. William Mitchell of Vanderbilt University School of Medicine in Tennessee, who worked on the study, said in a statement.

SCREENING AND MONITORING

“Laboratory tests using this approach may have the potential both to screen large populations for cancer before symptoms appear and to monitor patients for the recurrence of cancer once treated,” Mitchell added.

Much more testing needs to be done, Urnovitz said. But so far the test seems to specifically home in on breast cells. Unpublished data shows, for instance, that the DNA signature is not found in men with prostate cancer.

The cost of genetic sequencing will have to come down more before the test would be practical, Urnovitz added.

His team used Roche AG’s 454 sequencer at a cost of thousands of dollars per person, but companies are working to speed up sequencing and get the costs down.

The tests might be used to screen women for breast cancer and to tailor treatments, Urnovitz said.

“Imagine we can come in and say ‘you have damage to the protein kinase gene that would preclude you from these 10 cancer drugs, but here are 20 others that should work’,” he said.

“You would be selecting drug treatment based on each person’s lesions. This would be a really good example of personalized medicine.”

Urnovitz also hopes such a test could monitor patients who have completed treatment for cancer. Instead of coming to a cancer center to undergo a PET scan to check for tumors that may have returned, patients could get a blood test at their convenience and have it sent in for analysis.

“You could have one blood test for everything that is going on,” he said.

(Editing by Paul Simao)

Posted on

First U.S. stem cells transplanted into spinal cord

CNN Health

First U.S. stem cells transplanted into spinal cord

By Miriam Falco, CNN Medical News Managing Editor

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January 21, 2010 11:35 a.m. ESTJanuary 21, 2010 11:35 a.m. EST
Stem Cells Picture

Stem cells like these were injected into the spine of an ALS patient.
STORY HIGHLIGHTS
  • Fetal cells injected into spine of man with advanced ALS
  • There is no cure for ALS, better known as Lou Gehrig’s disease
  • At least 12 patients expected to participate in early research on stem cells and ALS
  • These are neural stem cells, which have ability to turn into different types of nerve cells

ATLANTA, Georgia (CNN) — For the first time in the United States, stem cells have been directly injected into the spinal cord of a patient, researchers announced Thursday.

Doctors injected stem cells from 8-week-old fetal tissue into the spine of a man in his early 60s who has advanced ALS, or amyotrophic lateral sclerosis. It was part of a clinical trial designed to determine whether it is safe to inject stem cells into the spinal cord and whether the cells themselves are safe.

ALS is a fatal neurodegenerative disease that causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. About 30,000 Americans have ALS at any given time, according to the ALS Association.

There is no cure for ALS, which is better known as Lou Gehrig’s disease, named after the New York Yankees’ first baseman and Hall of Famer who retired from baseball in the 1930s after being diagnosed with the disease.

As the illness progresses, patients lose their ability to walk, talk and breathe. Patients usually die within two to five years of diagnosis, according the ALS Association.

Neuralstem Inc., a Rockville, Maryland-based biotech company, received approval from the U.S. Food and Drug Administration to conduct the clinical trial in September. The company is fully funding the research and provides the stem cells that are being injected into the patients.

Neuralstem announced the start of the clinical trial in a news release Thursday.

Longtime ALS researcher and University of Michigan neurologist Dr. Eva Feldman is overseeing the first human clinical trial of a stem cell treatment in ALS patients.

“We are entering a new era of cell therapeutics for ALS, and in my opinion, it is an new era of hope for patients with ALS,” Feldman said.

At least 12 patients are expected to participate in this early research. They are to receive the stem cell transplants at Emory University in Atlanta, Georgia.

“This is the first study to see if the invasive injection into the spinal cord is safe for the patient,” said Lucie Bruijn, science director of the ALS Association.

This first patient in the clinical trial received several injections of stem cells into the lumbar region of the spinal cord, the area that controls leg function, because most ALS patients first lose muscle function in their legs, according to Karl Johe, Neuralstem’s chairman and chief scientific officer.

Bruijn says there have been a few other occasions outside the United States in which fetal stem cells have been injected into a patient, “but not necessarily using a very [rigorous] trial design.” She adds that there were also a couple of small studies in Italy that injected other types of stem cells into a few patients but that this is the first FDA-approved trial in the United States.

“Our biggest hope for stem cells is to significantly slow the progression the disease,” Bruijn said.

The ALS Association is not providing funding for this clinical trial, but it has supported the work of Dr. Nick Boulis, the Emory neurosurgeon who developed the surgical technique used to inject the stem cells.

Johe invented the technology that allows the company to manufacture billions of copies of stem cells that are taken from a single source of spinal cord cells: cells that were extracted from fetal tissue, which was donated to the company.

“The cells are human neural stem cells,” Johe said, acknowledging that the introduction of stem cells is a very invasive procedure.

“What we are attempting is a novel approach by directly injecting them into the middle of the spinal cord, which to our knowledge has never been done before,” Johe said.

Researchers plan to follow this and future patients participating in this trial for a long time to determine the safety of the procedure.

These particular stem cells — which came from the spinal cord of an 8-week-old fetus — are neural stem cells, which have the ability to turn into different types of nerve cells. These are not the same stem cells as the controversial human embryonic stem cells, which destroy the embryo when the stem cells are removed.

Johe says that once the safety of this type of transplant is determined, he and his colleagues hope to see whether this is a possible treatment for ALS.

“This is not a cure. We are not replacing those motor neurons [nerve cells which tell muscles to contract]. These stem cells don’t generate motor neurons. Instead they protect the still-functioning motor neurons,” Johe explained.

Bruijn says that injecting stem cells into the spinal cord — in the region where the motor neurons are located that affect ALS — is a breakthrough. But she cautions that this is only the first step in the first part of this clinical trial. It’s too early to draw any conclusions about the effectiveness of this treatment, especially since the trial has only just begun.

She notes that everyone involved with the study and other ALS patients have to wait and see what the results of the clinical trial will be.

The FDA granted the first approval for injecting human embryonic stem cells into humans to Menlo Park, California-based Geron Corporation in January 2009. Their trials were expected to start last summer but have yet to begin.

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FDA green lights stem-cell clinical trial for Lou Gehrig’s disease

NATURE PUBLICATIONS

FDA green lights stem-cell clinical trial for Lou Gehrig’s disease 

September 22, 2009

http://blogs.nature.com/news/thegreatbeyond/2009/09/fda_green_lights_stemcell_clin.html

Monya Baker

The Maryland company NeuralStem has the U.S. Food and Drug Administration’s permission to test its spinal cord stem cells in twelve patients with amyotrophic lateral sclerosis. The approval comes a month after the FDA placed Geron’s planned clinical trial on hold for a second time. NeuralStem’s trial had also previously been placed on hold by the FDA in February before receiving the go-ahead in September.

Though both trials involve placing cells into the spinal cord, NeuralStem’s product is made of cultured neural stem cells derived from a single 8-week fetus; Geron’s product, intended to treat spinal cord injury, is derived from embryonic stem cells that have been differentiated into precursors of neuron-support cells.

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ALS has not funded NeuralStem’s work directly, Briujn says, but has advised the company and funded academic scientists who’ve been involved with the company.

NeuralStem’s chief scientific officer Karl Johe says tests of large animal models show that the transplanted cells exert a neuroprotective effect over motor neurons, but it’s not entirely clear how. Earlier this year, Neuralstem and collaborators published results in a rat model of ALS showing that transplanted cells could develop into interneurons that formed synapses with the rats’ motor neurons.

However, Johe emphasized that the upcoming trial will assess safety rather than efficacy. The first few patients selected for the procedure will be those who are no longer able to walk. Because the injected cells protect rather than replace motor neurons, these sicker patients are less likely to benefit from treatment, but they are less able to lose function if something goes wrong. Cells will be injected only on one side of the spinal cord in order to minimize the number of injections into the spinal cord. Only one patient will be injected each month, so that researchers can monitor for effects over a longer period. Eventually, Johe says, the goal is to be able to inject cells in both lower and upper regions of the spinal cord in healthier patients, and see if the injections can keep motor neurons healthy.

The trial is expected to take place at Emory University in Atlanta, Georgia. Though the FDA is allowing the trial to go forward, the university’s patient-safety board will also need to approve the trial before it can proceed. Johe declined to say when that would be but said discussions were well underway.

Other companies using neural cells include ReNeuron, which received permission from UK authorities this January to start clinical trials for stroke. Its cell product is made from genetically modified cultures of neural stem cells, also of fetal origin.

StemCells Inc is conducting trials in Batten’s disease, a neurodegenerative disease that strikes children, and recently received approval for a clinical trial for a similar disease. It also uses neural stem cells from material originally derived from fetuses and has recently published results showing that its cell product delayed some symptoms of the disease by about three weeks.

As with human embryonic stem cells, the patent situation for neural stem cells is contentious. In a pair of dueling press releases this May, NeuralStem and Stem Cells Inc both claimed key intellectual property on these cells.