Stem cells for neck injury: $20 million

Stem cells for neck injury: $20 million July 27th, 2012, 3:45 pm posted by Pat Brennan, science, environment editor

Human neural stem cell. Image courtesy StemCells Inc.

The states stem-cell institute has awarded $20 million to UC Irvine researchers, along with a private company, to prepare the way for human testing of a treatment for spinal-cord injuries in the neck region one that could restore movement and independence for some of the 1.3 million spinal-cord injury sufferers in the United States.

The treatment, developed by the husband and wife research team, Aileen Anderson and Brian Cummings, along with StemCells Inc. of Newark, Ca., would involve injecting versatile human neural stem cells into the neck area.

The cells, capable of transforming themselves based on cues from the body, could then migrate to the injured area and perhaps repair the protective sheaths, known as myelin, around nerve cells. If the treatment works as expected, it would restore movement and body control for patients with debilitating injuries.

While the treatment has the potential to allow the paralyzed to walk again, more modest gains are more likely and well worth the effort, Anderson said Friday.

UC Irvine husband-wife research team, Brian Cummings and Aileen Anderson. Courtesy UC Irvine.

Obviously that would be, of course, what we in our wildest dreams would see in a clinical trial, she said. But likely what youre going to see for any spinal cord injury is much more incremental improvement in function. For people with spinal cord injuries, that could be a huge thing. It could help with health care costs, the ability to function independently. If you can type on a computer, versus not, or write with a pen it changes an awful lot.

The $20 million was among $150 million authorized on Thursday by the board of the California Institute for Regenerative Medicine, a stem-cell funding body created by a California voter initiative in 2004.

Anderson and Cummings are among a cadre of stem-cell scientists at UCIs Sue & Bill Gross Stem Cell Research Center, and have already pushed the field forward.

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Stem cells for neck injury: $20 million

UC Davis gets $53 million in stem cell funds to study Huntington's, other diseases

The University of California, Davis, scored a major coup in stem cell funding with a $53 million award Thursday for research into Huntington's disease, limb ischemia and osteoporosis.

The grants were approved Thursday afternoon by CIRM the California Institute for Regenerative Medicine. They are a major milestone for the university, which had received $73 million in past funding from the state agency.

"We're here to bring this new era of medicine to patients," UC Davis stem cell program director Jan Nolta said.

For Melissa Biliardi of Santa Maria, the vote symbolizes hope. Her son, James Birdsall, 32, was diagnosed four years ago with Huntington's disease. The degenerative brain disorder could prove fatal over the next 10 to 15 years. There is currently no cure or treatment, but with the grant, UC Davis researchers hope to deliver an effective therapy in four years.

"This is the most hope we've ever had for a cure or treatment," Biliardi said.

Her son suffers from involuntary movement and fatigue, all symptoms of the disease, and relies on a wheelchair to get around. Birdsall is one of 30,000 Americans living with the genetic disorder, according to Nolta. Another 150,000 are at risk, but many aren't diagnosed until their early 30s.

Created by voters in 2004, CIRM is financed by state bonds. The agency started with a $3 billion fund in 2007. Since then, it has doled out a quarter of its money about $900 million to various universities and private companies doing stem cell work in the state.

"We're driving opportunity here," CIRM President Alan Trounson said.

Huntington's is caused by toxic proteins that kill nerves in the brain. Limb ischemia causes blood clots that eventually lead to amputation. Osteoporosis is characterized by a loss in bone mass.

Together, the diseases afflict millions of Americans each year. UC Davis researchers said they are on the cusp of a major breakthrough to treating all three.

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UC Davis gets $53 million in stem cell funds to study Huntington's, other diseases

State stem cell research funding agency awards $20 million to UCI, StemCells Inc.

Public release date: 27-Jul-2012 [ | E-mail | Share ]

Contact: Cathy Lawhon clawhon@uci.edu 949-824-1151 University of California - Irvine

Irvine, Calif., July 26, 2012 Efforts to begin human clinical trials using stem cells to treat cervical spinal cord injury in the U.S. received a $20 million boost Thursday, July 26, from the state's stem cell research funding agency, the California Institute for Regenerative Medicine.

The award will be shared by Aileen Anderson and Brian Cummings, associate professors of physical medicine & rehabilitation at UC Irvine's Sue & Bill Gross Stem Cell Research Center, and Nobuko Uchida of StemCells Inc. in Newark, Calif. Anderson and Cummings proved that transplanting human neural stem cells discovered and developed by Stem Cells, Inc. into rodents with thoracic spinal cord injury could restore mobility. The CIRM award announced Thursday will fund the collection of data necessary to establish human clinical trials in the U.S.

"Our therapeutic approach is based on the hypothesis that transplanted human neural stem cells integrate into the injured spinal cord to repair the protective myelin sheath and spinal circuitry," Anderson said. "Any therapy that can partially reverse some of the effects of spinal cord injury could substantially change the quality of life for patients by altering their dependence on assisted living and medical care."

CIRM's governing board on Thursday gave authorized $150 million for eight teams at five institutions statewide. The projects backed are considered critical to the institute's mission of translating basic stem cell discoveries into clinical cures.

"CIRM's support for UC Irvine's efforts to advance novel stem cell-based therapies for a variety of diseases is extremely gratifying," said Peter Donovan, director of the university's Sue & Bill Gross Stem Cell Research Center. "This latest award for spinal cord treatment holds great promise. We are delighted."

About 1.3 million Americans suffer chronically from spinal cord injuries. In California, nearly 147,000 individuals are living with such damage, which can severely impair the movement, sensation and autonomic function of otherwise healthy people. Recovery from spinal cord injury is often limited, even after aggressive emergency intervention with steroids and surgery, followed by rehabilitation.

"That's crushing for anyone," Anderson noted. "It's very tough for patients and their families. We believe stem cell therapies could provide significant functional recovery, improve quality of life and reduce the cost of care for those with spinal cord injury. That's our goal."

Anderson's and Cummings' laboratory has a long history of collaboration with StemCells Inc. in addressing spinal cord injury, including studies that led to the world's first clinical trial of a neural stem cell therapy for chronic spinal cord injury. This Phase I/II clinical trial, currently under way in Zurich, recently reported positive safety data from the first cohort of treated patients and continues to enroll subjects.

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State stem cell research funding agency awards $20 million to UCI, StemCells Inc.

Malaya Business Insight

Details Published on Friday, 27 July 2012 00:00

STEM cell therapy is being eyed to cure the neck and back pains and other illnesses of former president and now Pampanga Rep. Gloria Arroyo, alternative medicine doctor Antonia Park said yesterday.

Arroyo went to Parks Green and Young Health and Wellness Center in Tagaytay City yesterday morning for cleansing and alternative healing.

A guard at the La Vista Subdivision in Quezon City, who requested anonymity, said Arroyo left the subdivision at around 7:30 a.m., accompanied by a few staff and a personal nurse. She rode a white Nissan Patrol and her convoy included a gray Toyota Land Cruiser and a police escort.

Arroyo was granted bail Wednesday by a Pasay City court after finding that the electoral sabotage case against her was weak. She posted a P1-million cash bond.

Stem cell treatment involves the introduction of new adult stem cells into the damaged tissue in order to treat a disease or injury. The ability of new cells to regenerate is seen as having significant potential to replace diseased areas of the body, with minimal risk of rejection and side effects.

Park, in a statement distributed to the media, said Arroyo complained of difficulty in swallowing with choking due to her bulge along the posterior pharyngeal wall, together with a change of her voice and losing weight due to her difficulties of swallowing the food (solid) and angina as well as continuous neck and back pain.

Thats why our center is accepting her for possible stem cell therapy and another treatment of pain management and giving natural food by means of fresh fruit and vegetable juices for which management is warranted and which the stem cell therapy is contemplated and strongly considered, she said.

She said the stem cell therapy can be given by her clinic in Tagaytay while Arroyo can continue her physical therapy at the Veterans Memorial Medical Center four times a week.

Park said Arroyo can to go her district, referring to the second district of Pampanga, over the weekend provided she takes care to wear a brace and avoid talking too much so as to protect the bulging interior of the throat, and provided she resumes physical therapy as soon as possible.

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Malaya Business Insight

ACT Issued Broad Patent for Human RPE Cells Derived From All Types of Pluripotent Stem Cells

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has been issued a patent in Australia, patent number 2005325753, Improved modalities for the treatment of degenerative diseases of the retina. The patent broadly covers the use of human retinal pigment epithelial (RPE) cells generated from pluripotent stem cells in the manufacture of pharmaceutical preparations of RPE cells, and the use of those preparations to treat patients with degenerative diseases of the retina such as Age-related Macular Degeneration. The patent covers the pharmaceutical formulation of human RPE cells made from a range of pluripotent stem cells, including both human embryonic stem cells (hESCs) and human induced pluripotent stem (iPS) cells.

We continue to make great progress with our patent estate covering RPE therapies, said Gary Rabin, chairman and CEO of ACT. Our ongoing success in securing broad patent protection around the world, including this newly-issued Australian patent, is a testament to our innovative chief scientific officer, Dr. Robert Lanza, and the rest of our scientific team.

The efficient production of highly pure RPE cell preparations represents a critical step in the creation of renewable sources of transplantable cells that can be used to target degenerative diseases of the eye such as Stargardts Macular Dystrophy (SMD) and dry Age-related Macular Degeneration (dry AMD).

Our current embryonic stem cell trials pave the way for other pluripotent stem cell therapies, commented Dr. Lanza. ACTs cellular reprogramming technologies using iPS cells are in an advanced stage of development, and we hope to be in a position to move toward clinical translation in the not-too-distant future. Since iPS cells can be made from the patients own cells such as skin or blood cells they may allow us to expand our cell therapies beyond immune-privileged sites such as the eye without the risk of immune rejection.

Mr. Rabin concluded, We are aggressively pursuing patent protection for a variety of aspects of our programs. Our intellectual property strategy includes both vigilance in pursuing comprehensive coverage from our initial patent filings, such as this new Australian patent, and filing for protection around our scientific teams various innovations. At the same time we are paying close attention to including within our patent coverage those ways others may wish to adapt our technology for commercial use, such as through the choice of stem cell source, or the use of solid supports or cell suspensions for delivery. Following this strategy, we are establishing both formidable barriers-to-entry for potential competitors, as well as strong potential licensing opportunities for others, translating into solid revenue generation possibilities for the company.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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ACT Issued Broad Patent for Human RPE Cells Derived From All Types of Pluripotent Stem Cells

Arroyo might undergo stem cell therapy

MANILA, Philippines - Former President Gloria Macapagal-Arroyo might undergo stem cell therapy to improve her health, according to the alternative medicine facility in Tagaytay City that the Pampanga lawmaker visited Thursday.

Arroyo came to the facility complaining of difficulty in swallowing because of a bulge in her throat, according to a statement from the Green 8 Young Health & Wellness Center.

Her voice has also changed and she is losing weight because she can't swallow solid food. She also has angina, the center said.

Arroyo also complained of continuing neck and back pain.

"Our center is accepting her for possible stem cell therapy," the alternative medicine facility said. "The stem cell therapy is... strongly considered."

It said the Arroyo can undergo such therapy in the Tagaytay center while her physical therapy will continue at the Veterans Memorial Medical Center 4 times a week.

The Pampanga lawmaker is seeking treatment at the center through her sister, Cielo Macapagal-Salgado.

The center said Salgado was previously diagnosed with a cancerous lump in her breast.

"She consulted several doctors and was subsequently subjected to a myrad of treatment procedures. These, however, did not produce the desired results. When she came to our center she was cured of her cancer," it claimed.

Arroyo heads to Pampanga

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Arroyo might undergo stem cell therapy

Ruling frees FDA to crack down on stem cell clinics

Peter Aldhous, San Francisco bureau chief

It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use.

It was on this basis that in 2008 the FDA began moves to shut downRegenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx.

Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling.

Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. "This is really round one," he says. "Our position remains that a patient's cells are not drugs."

Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials.

"I think it's a good ruling, and I'm glad to see that that the FDA has exercised its muscle on the case," says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.

Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.

Last month, the Houston Chronicle revealed that FDA inspectors had found multiple violations of good manufacturing practice at Celltex.

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Ruling frees FDA to crack down on stem cell clinics

Seventeenth Patient Dosed in Neuralstem ALS Stem Cell Trial

ROCKVILLE, Md., July 25, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that the seventeenth patient was treated in the ongoing Phase I trial of its spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This patient is also the second to return to the trial for additional injections. In this treatment, the patient received five injections in the cervical (upper back) region of the spinal cord, in addition to the ten he had previously received in the lumbar (lower back) region, for a total of 15 injections. The final previously treated patient of this cervical cohort is expected to return to the trial in August, provided the inclusion requirements continue to be met. This ground-breaking stem cell trial is taking place at Emory University Hospital in Atlanta, Georgia.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"We are pleased that this phase of the trial, in which we have been permitted by the FDA to take the unprecedented step of dosing patients for the second time, is progressing as planned," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "These are the first patients in the world to receive our cells in both the lumbar and cervical regions of their spinal cords, where the stem cell therapy could support both walking and breathing."

About the Trial

The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.

The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The current cohort of three is receiving injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The second of these returning patients was just treated. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

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Seventeenth Patient Dosed in Neuralstem ALS Stem Cell Trial

Stem Cell Treatment Alleviated Lorna Tolentino's Back Pain

By ROWENA JOY A. SANCHEZ

LT is noticeably more blooming these days (Publicity photo)

MANILA, Philippines As if by stroke of magic, Lorna Tolentinos back pain was eliminated after getting stem cell treatment at a hospital in Germany on July 3.

The whole process only took four days, which included a day for an interview about her health history. The second day was for the treatment itself, with Lorna receiving 10 injections. She rested on the third day and was discharged on the fourth.

In a recent interview with Bulletin Entertainment and some members of the media, Lorna enthused, Ang instant [na nawala] sa akin yung back pain talaga Kasi iba yung pakiramdam ng wala kang iniinda na sakit sa likod. Dati pag lumalakad ako, mabagal Pag lumalakad ako pinupukpok ko na tong paa ko dahil nagna-numb na yung dito (part of her legs) ko.

The back pain, she noted, was caused by scoliosis, a disorder that causes an abnormal curve of the spine, or backbone, according to medicinenet.com.

Although her aura is noticeably more bloomingwhich can perhaps be attributed to the treatmentthe Kapatid actress emphasized that it will take three months before the changes completely take effect.

Such immediate relief and the no side effects assurance apparently came with a huge price. The treatment is said to have cost P1 million. Lorna did not shell a single cent, though, with executive consultant Joey Santos shouldering the expenses.

Mabait sa akin si Lord, Lorna said.

According to Mayo Clinic, stem cell therapy, which is also known as regenerative medicine, "is the replacement of diseased, dysfunctional or injured cells with stem cells or their derivatives. It's somewhat similar to the organ transplant process but uses cells instead of organs."

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Stem Cell Treatment Alleviated Lorna Tolentino's Back Pain

Driver of breast cancer stem cell metastasis found

ScienceDaily (July 24, 2012) Researchers at the University of Michigan Comprehensive Cancer Center have found that a cancer gene linked to aggressive spread of the disease promotes breast cancer stem cells. The finding implies a new way to target the behavior of these lethal cells.

The finding involves the cancer gene RhoC, which has previously been shown to promote metastasis of many types of cancer. RhoC levels increase as breast cancer progresses and high levels of RhoC are associated with worse patient survival.

Cancer stem cells are the small number of cells within a tumor that are believed to fuel the tumor's growth and spread. Researchers believe traditional chemotherapy and radiation treatments often become ineffective because they do not kill the cancer stem cells, and that the key to future treatments is to develop drugs that target and kill these cells.

This new study, which appears online in PLoS ONE, suggests a new way to get at the cancer stem cells.

"Targeting the specific molecular cogs driving the cancer stem cell machinery responsible for the cancer spreading has potential for future treatments. Eliminating cancer stem cells may ultimately be necessary to cure certain cancers, but in the meantime, we may be able to manage the cancer stem cell population and the invasive behaviors of these cells by disrupting the molecular machinery, using RhoC as a target," says senior study author Sofia D. Merajver, M.D., Ph.D., professor of internal medicine and epidemiology at the University of Michigan and scientific director of the breast oncology program at the U-M Comprehensive Cancer Center.

The researchers looked at breast cancer cell lines that were highly metastatic and cell lines from normal breast tissue. By inhibiting or overexpressing RhoC, they found that RhoC expression is necessary to cause metastasis in both cell lines, and that RhoC overexpression alone can cause metastasis. The researchers also tested this in mice and had similar results.

Merajver's lab, in conjunction with other U-M researchers, is studying a novel small molecule drug to inhibit RhoC, which has shown promising initial results in the laboratory. The researchers are continuing to develop this inhibitor, which will require several years of additional testing in the laboratory before potentially advancing to clinical trials.

Breast cancer statistics: 229,060 Americans will be diagnosed with breast cancer this year and 39,920 will die from the disease, according to the American Cancer Society

Additional authors: Devin T. Rosenthal, Jie Zhang, Liwei Bao, Lian Zhu, Zhifen Wu, Kathy Toy and Celina G. Kleer, all from U-M

Funding: Department of Defense Breast Cancer Research Program (BC083262); National Institutes of Health (T32-GM07315); Burroughs Wellcome Fund; Breast Cancer Research Foundation

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Driver of breast cancer stem cell metastasis found