Stem Cell Clinic

Lame dogs brought to heal with stem cells Save

July 29, 2012, 3 a.m.

Up for a walk ... Denise Stuckey, with her dog, Bella, who has had stem cell treatment from vet Joe Sulyok.

Stem cell injections in dogs will become routine in the next two years and will probably cost less than $1000.

The first data, collated last week, into the use of the procedure where cultured cells are injected into the joints of dogs with hip dysplasia or canine osteoarthritis has shown a success rate of 96 per cent.

The procedure will be made available to veterinary clinics, promoted at dog shows and possibly in a television campaign.

It has been transformed in little more than a year with stem cells from one animal used to treat other dogs.

Previously, an invasive procedure was necessary, with incisions to remove subcutaneous or fatty tissue from the affected dog and stem cells isolated in a laboratory before being injected back into the dog.

The procedure resulted in a culture containing only about 10 per cent to 15 per cent stem cells, while the culture from a donor in a breed with a genetic line clear of arthritis can been screened to provide a culture containing 100 per cent stem cells.

The figures were collected from vets by Australian Veterinary Stem Cells, which supplies stem cell treatments and has a partnership with the immunology and stem cell research department at Monash University in Melbourne.

The sample size for the study was small at 150 but only about 1000 animals have had the treatment.

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It saved Ciaran, but America split on stem-cell cure

When news emerged last week that 13-year-old Ciaran Finn-Lynch is healthy two years on from having revolutionary stem-cell surgery to replace his windpipe, Atlanta's Erica Lyles Greene, whose brother underwent a similar procedure last November, had words of praise for the teen.

"Thank you for being so brave," Erica said of young Ciaran. "He did it two years ago. And how amazing is it that he is alive and well? This is exactly what my brother had hoped for."

Christopher Lyles (30) was diagnosed with a rare form of tracheal cancer in June 2011. Over the next three months, he endured 33 rounds of radiation treatment and seven of chemotherapy.

Finally, his doctors informed him that the tumour was too big to operate on and that they could do no more.

Erica and an aunt began trawling the internet for possible cures, when they came across Dr Paolo Macchiarini, the director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm, who was at the cutting-edge of tracheal transplants.

Amazingly, in spite of the fact that reports about Dr Macchiarini's work were easily found on the internet, Christopher's doctors hadn't a clue about it.

"They had no idea that someone was performing tracheal transplants," Erica said. "And they said 'It's in Europe. Why are you looking there? That's kinda kooky.' And we said 'No, it's not'."

Stem-cell research has been contested terrain in America for decades. The battle has largely revolved around the issue of embryonic stem-cells.

Pro-life activists have waged a very active campaign to block the use of embryonic stem-cell use, insisting that life begins at conception and that destroying an embryo is, therefore, taking a human life.

Stem-cell research in the US still lags behind efforts in other parts of the world.

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It saved Ciaran, but America split on stem-cell cure

StemCells, Inc. Broadens HuCNS-SC(R) Patent Portfolio With Key Patent in Japan

NEWARK, Calif., July 31, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the Japan Patent Office has granted to the Company Patent Number 5007003, titled "Enriched Central Nervous System Stem Cell and Progenitor Cell Populations, and Methods for Identifying, Isolating and Enriching for Such Populations." The patent broadly covers the prospective isolation and enrichment of neural stem and progenitor cells using antibody selection, as well as the use of these cells to treat disorders of the central nervous system. Some of the more noteworthy claims in the '003 patent include methods for isolating human neural stem cells, as well as compositions of matter comprising enriched neural stem cells, such as the Company's proprietary HuCNS-SC cells, and the use of enriched neural stem cells as a medicament for the treatment of neurodegenerative diseases, acute brain injury and dysfunction of the central nervous system. The invention claimed by the '003 patent was the result of groundbreaking research conducted by the Company's stem cell researchers, including Nobuko Uchida, Ph.D., Vice President of Stem Cell Biology at StemCells, Inc., who is a named inventor on the patent. The patent term of the '003 patent extends into 2020.

"The issuance of the '003 patent in Japan further strengthens our intellectual property position around our neural stem cell technology," said Martin McGlynn, President and CEO of StemCells, Inc. "Our HuCNS-SC clinical development program continues to move forward, targeting such conditions as Alzheimer's disease, spinal cord injury, myelin disorders, and diseases of the eye. This patent is another testament to the excellent and innovative science conducted by our researchers, who are leaders in the field of stem cell biology and, like the rest of our IP portfolio, will help to protect the significant investment we have made in developing our unique neural stem cell technology."

The Company's patent portfolio consists of approximately 40 issued U.S. patents, 250 issued foreign patents and active patent prosecution in over 14 distinct patent families claiming different types of stem and progenitor cells, cell culture media, stem cell research tools and techniques, and similar technologies. The Company's issued neural stem cell patents broadly cover human neural stem cells irrespective of whether they were derived from embryonic, juvenile or adult tissue, or derived using presently known induced pluripotent stem cell (iPS) technologies. The Company's neural stem and progenitor cell patents cover (i) compositions of matter, (ii) methods of manufacture (isolation, proliferation, purification, genetic modification, etc.), and (iii) methods of use, including the use of these cells both as therapeutics and as tools for drug screening and testing.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and recently reported positive interim safety data for the first patient cohort. The Company has also initiated a Phase I/II clinical trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the prospect of enforcing the Company's intellectual property against infringers, the potential breadth and length of patent protection in Japan or in any other geography; the likelihood that any of the Company's intellectual property will be found to be valid and enforceable; and whether the Company will be able to manufacture HuCNS-SC cells consistently and as needed to conduct the Company's on-going clinical studies. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the Company's ability to obtain the increased capital resources needed to continue its current operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals and for continued patent prosecution efforts; uncertainty regarding the validity and enforceability of the Company's existing patents; the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury, age related macular degeneration or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the Company's ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and in its subsequent reports on Form 10-Q and Form 8-K.

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StemCells, Inc. Broadens HuCNS-SC(R) Patent Portfolio With Key Patent in Japan

Stem cell therapy could offer new hope for defects and injuries to head, mouth

ScienceDaily (July 30, 2012) In the first human study of its kind, researchers found that using stem cells to re-grow craniofacial tissues -- mainly bone -- proved quicker, more effective and less invasive than traditional bone regeneration treatments.

Researchers from the University of Michigan School of Dentistry and the Michigan Center for Oral Health Research partnered with Ann Arbor-based Aastrom Biosciences Inc. in the clinical trial, which involved 24 patients who required jawbone reconstruction after tooth removal.

Patients either received experimental tissue repair cells or traditional guided bone regeneration therapy. The tissue repair cells, called ixmyelocel-T, are under development at Aastrom, which is a U-M spinout company.

"In patients with jawbone deficiencies who also have missing teeth, it is very difficult to replace the missing teeth so that they look and function naturally," said Darnell Kaigler, principal investigator and assistant professor at the U-M School of Dentistry. "This technology and approach could potentially be used to restore areas of bone loss so that missing teeth can be replaced with dental implants."

William Giannobile, director of the Michigan Center for Oral Health Research and chair of the U-M Department of Periodontics and Oral Medicine, is co-principal investigator on the project.

The treatment is best suited for large defects such as those resulting from trauma, diseases or birth defects, Kaigler said. These defects are very complex because they involve several different tissue types -- bone, skin, gum tissue -- and are very challenging to treat.

The main advantage to the stem cell therapy is that it uses the patient's own cells to regenerate tissues, rather than introducing human-made, foreign materials, Kaigler said.

The results were promising. At six and 12 weeks following the experimental cell therapy treatment, patients in the study received dental implants. Patients who received tissue repair cells had greater bone density and quicker bone repair than those who received traditional guided bone regeneration therapy.

In addition, the experimental group needed less secondary bone grafting when getting their implants.

The cells used for the therapy were originally extracted from bone marrow taken from the patient's hip. The bone marrow was processed using Aastrom's proprietary system, which allows many different cells to grow, including stem cells. These stem cells were then placed in different areas of the mouth and jaw.

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Stem cell therapy could offer new hope for defects and injuries to head, mouth

Osiris Therapeutics Reports Second Quarter 2012 Financial Results

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the second quarter ended June 30, 2012.

Highlights and Recent Developments

This past quarter was not only memorable, but monumental, for Osiris, stated C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. We have set a new benchmark to measure our success, and remain as committed as ever to extending the reach of this remarkable technology. Whether through our Biosurgery or Therapeutics units, we will continue to develop innovative cell therapy solutions for patients in need.

Second Quarter Financial Results

Biosurgery product revenue rose 43% from the previous quarter to $1.63 million. As of June 30, 2012, Osiris had $40.1 million of cash, receivables and short-term investments.

Research and development expenses for the second quarter of 2012 were $4.1 million, compared to $5.2 million incurred in the second quarter of 2011. General and administrative (G&A) expenses were $1.4 million for the second quarter of 2012 compared to $3.3 million for the same period of the prior year. The 2011 G&A expense included a non-cash charge of $1.7 million related to the extension of the expiration date of a warrant. Net cash used in operations for the three months ended June 30, 2012 was $4.4 million.

Webcast and Conference Call

A webcast and conference call to discuss the financial results is scheduled for today, July 30, 2012 at 9:00 a.m. ET. To access the webcast, visit the Investor Relations section of the company's website at http://investor.osiris.com/events.cfm. Alternatively, callers may participate in the conference call by dialing (877) 303-6133 (U.S. participants) or (970) 315-0493 (international participants).

A replay of the conference call will be available approximately two hours after the completion of the call through August 05, 2012. Callers can access the replay by dialing (855) 859-2056 (U.S. participants) or (404) 537-3406 (international participants). The audio replay confirmation code is 99408506. To access a replay of the webcast, visit the Investor Relations section of the company's website at http://investor.osiris.com/events.cfm.

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Osiris Therapeutics Reports Second Quarter 2012 Financial Results

Cayden's second chance: 5-year-old has stem cell injection that may help his vision

The quest to save her grandson's eyesight began more than four years ago when Carmie Carr discovered a business on the Internet offering experimental stem cell injections in China.

At 4 months old, Cayden Baggett was diagnosed with optic nerve hypoplasia, a condition where the nerves in the eyes never fully develop. His family was told he would eventually go blind. Right now, Cayden can see light and dark, but little else.

Soon after learning about the stem cell treatments, the Carr family launched a campaign to raise $50,000 to cover the costs. The 2010 Gulf oil spill, coupled with the 2011 tornadoes in Tuscaloosa that destroyed their retail business, made collecting the funds next to impossible, they said.

Then, a friend told the family about a construction project he was working on just down the street. It was for a local radiologist who planned to offer stem cell injections to athletes with sports-related injuries.

He introduced the Carrs to Dr. Jason Williams. After talking with the family and researching the procedures, Williams agreed to help.

"There is no doubt in my mind this is the road the Lord has been leading us down," said Carmie Carr. "It connected like a perfect puzzle. We thought we were going to have to travel around the world. Instead, we drove four blocks."

A goal of Cayden's stem cell treatment is to stimulate new nerve growth that might improve his vision. Some children with similar health problems have shown marked improvement in recent years after being treated with stem cells in China, Carmie Carr said.

When the day of his procedure finally arrived, a groggy Cayden, now 5, was carried by his mother, Leanna Carr, into the Gulf Shores medical practice. During the procedure, Williams used the little boy's own fat through liposuction to harvest stem cells that were processed, then injected into his back.

Stem cells, sometimes called the body's master cells, are precursor cells that can develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use. Their promise in medicine, researchers say, is that the cells have shown potential to help regenerate other cells.

For about four months, Williams, a radiologist, has been performing stem cell injections, which are considered investigational in the U.S., at his Baldwin County practice. He has said the procedures meet FDA guidelines because the stem cells are collected from a patient's fat tissue and administered back to the same person.

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Cayden's second chance: 5-year-old has stem cell injection that may help his vision

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

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

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

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