ACT Treats 10th Patient in Embryonic Stem Cell Trials for Macular Degeneration

By adminJuly 30, 2012Stem Cell Treatment

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the final patient in the first patient cohort in its Phase 1/2 clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, July 27 at Moorfields Eye Hospital in London, the same site as the first two treatments, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The outpatient transplant surgery was performed successfully without any complications, and the patient is recovering uneventfully. This is the tenth patient overall to now be treated with the RPE cell therapy developed by the company.

Our European trial is making very steady progress, having now completed enrollment of the first patient cohort, commented Gary Rabin, chairman and CEO. We are very encouraged and look forward to receiving clearance to initiate the treatment of the second patient cohort in the coming weeks.

The Phase 1/2 trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the studys primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. It is similar in design to the U.S. trial for SMD that was initiated in July 2011.

This is a significant month for the company, continued Mr. Rabin. One year ago we treated the first of our patients in our two U.S. clinical trials. The one-year follow-up for those initial patients indicates that the improvements in visual acuity we initially reported have in fact persisted now for a year. Indeed, we are consistently observing improvements in subjective and objective visual acuity for patients being treated at the various clinical centers involved in our trials. Again, these trials are still at very early stages, but these preliminary results indicate that we are on the right track.

The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially designated ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells as an orphan medicinal product for the treatment of SMD.

About Stargardts Disease

Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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.

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ACT Treats 10th Patient in Embryonic Stem Cell Trials for Macular Degeneration

Stem Cell Treatment = Drug

By adminJuly 30, 2012Stem Cell Treatment

A US federal court rules that procedures in which a patients own stem cells are extracted, manipulated, and reinjected should be regulated by the FDA.

By Bob Grant | July 30, 2012

Leonardini | stock.xchng

After years of legal wrangling, the US District Court in Washington, DC, last week upheld the Food and Drug Administrations power to regulate adult stem cell treatments in which the cells are more than minimally manipulated before being injected back into the patient. The court ruled that the FDA was operating within its legal mandate when it filed suit against Colorado-based stem cell treatment clinic Regenerative Sciences in 2010 to stop them from extracting, processing, and then reinjecting patients own bone marrow stem cells to treat bone and joint disorders.

The FDA argued that the treatment fell under its purview and was subject to approval like any new drug because the extracted cells were significantly modified using reagents that cross state lines. Regenerative Sciences disagreed, characterizing the treatment as a simple medical procedure, which dont require FDA approval. The court sided with the FDA, making similar stem cell clinics popping up in the United States take notice. University of Minnesota bioethicist Leigh Turner told Nature that the ruling was spot on. It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a manufacturing process that includes risk of transmission of communicable diseases, he said. Maintaining the FDAs role as watchdog and regulatory authority is imperative.

But Chris Centeno, Regenerative Sciences medical director told Nature that the clinic plans to continue offering patients 3 of its 4 stem cell treatments, in which cells are only processed for 2 days before reinjection. He added that the company will continue to treat patients using the process now prohibited by the FDA in a clinic located in the Cayman Islands and that Regenerative Sciences plans to appeal the courts ruling.

By Edyta Zielinska

The National Institutes of Health will fund 17 projects developing lab-on-a-chip applications to improve drug screening.

By Cristina Luiggi

After treating terminally ill patients with an unauthorized experimental probiotic procedure, two California doctors can no longer participate in human research.

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Stem Cell Treatment = Drug

Jamie’s dad to be stem cells donor

By adminJuly 28, 2012Stem Cell Treatment

Father of Jamie Inglis to be stem cells donor

9:37am Saturday 28th July 2012 in News By Kate Liptrot, kate.liptrot@thepress.co.uk

THE father of a six-year-old boy bravely fighting cancer is likely to be a stem cell donor for medical treatment which could potentially save his life.

Jamie Inglis has a 75 per cent chance of survival if he successfully goes through a clinical trial in Germany, according to his oncologist at Leeds General Infirmary, an expert on neuroblastoma.

This form of cancer is so aggressive that treatment in the UK is inadequate and will prolong Jamies life only for months, so his family are in the process of raising 250,000 to fund the treatment. They have currently raised about 80,000.

Jamies parents, John and Vicky, of Kelfield, near Selby , have been tested to see who would be the most appropriate donor.

John has been chosen by the experts because he has the best properties to assist Jamies immune system, which does not recognise cancer cells.

He is due to travel to Germany in early August, when he will have tests to detect any defects and to clarify that he can definitely be a donor.

Mr Inglis said: We are really pleased, we feel quite positive we have got to the main point, which is killing the disease he had. We are getting closer to receiving the treatment. He said Jamie is also due for an appointment with his oncologist next week and for an MRI scan soon.

Jamie, a pupils at Lord Deramores Primary School in York, is due to travel to undergo treatment in Tubingen in Germany from August 20.

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Jamie’s dad to be stem cells donor

Stem cells for neck injury: $20 million

By adminJuly 28, 2012Stem Cell Treatment

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

By adminJuly 27, 2012Stem Cell Treatment

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.

By adminJuly 27, 2012Stem Cell Treatment

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

By adminJuly 26, 2012Uncategorized

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

By adminJuly 26, 2012Stem Cell Treatment

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

By adminJuly 26, 2012Stem Cell Treatment

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

By adminJuly 26, 2012Uncategorized

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