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Stem cell treatment for ALS gets clinical trial greenlight from FDA

By Stem Cell Treatment

(Reuters) - BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration approved the start of a mid-stage clinical trial of its adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS).

The Phase II trial will be launched initially at Massachusetts General Hospital in Boston and the University of Massachusetts Memorial Hospital in Worcester.

Dana-Farber Cancer Institute's Connell O'Reilly Cell Manipulation Core Facility will manufacture BrainStorm's NurOwn cells for these two clinical sites. The trial will also be conducted at the Mayo Clinic, the Israel-based company said on Sunday. The trials are expected to start soon.

"Today's announcement represents the most significant milestone BrainStorm has achieved to date," the company's president, Chaim Lebovits, said.

This trial will be the first Phase II double-blinded stem cell study to be conducted for ALS, he added.

ALS, also known as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.

BrainStorm's Phase II trial is designed to evaluate the safety and efficacy of transplantation of the stem cells in 48 ALS patients. The cells will be administered via intramuscular and intrathecal injection.

Patients will be followed monthly for three months before transplantation and for six months following transplantation.

Earlier clinical trials have shown that treatment with NurOwn cells was well tolerated and safe.

Last week, Cytokinetics Inc said its experimental treatment for Lou Gehrig's Disease failed the main goal in a mid-stage trial.

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Stem cell treatment for ALS gets clinical trial greenlight from FDA

Center for Joint Regeneration in Phoenix Now Offering Stem Cell Procedures for Nonoperative Rotator Cuff Tendon Repair

By Stem Cell Treatment

Phoenix, Arizona (PRWEB) April 28, 2014

Center for Joint Regeneration is now offering stem cell procedures for nonoperative rotator cuff repair with Board Certified orthopedic doctors. The regenerative medicine procedures are performed as an outpatient and involve either bone marrow derived or amniotic derived stem cell material. Call (480) 466-0980 for more information and scheduling.

Millions of Americans are affected by shoulder pain due to a rotator cuff bursitis or tendon tear. The pain may persist for months and may end up needing surgery if traditional treatments fail. These may include steroid injections, physical therapy and pain medication.

Treatment with regenerative medicine has now become available with stem cell material. The Board Certified orthopedic doctors at Center for Joint Regeneration offer stem cell procedures for rotator cuff injuries with either bone marrow or amniotic derived stem cells.

The bone marrow stem cells involve harvesting the material in a short procedure from the patient, with immediate processing to concentrate the stem cells and growth factors for injection into the shoulder. The amniotic material is obtained from consenting donors after a scheduled c-section procedure. There is no fetal tissue used at all, alleviating any ethical concerns.

Small studies to date have shown stem cell procedures to work well for pain relief and restoration of function with musculoskeletal conditions such as knee arthritis, ligament injury and tendonitis. The stem cell material includes growth factors, stem cells, hyaluronic acid and anti-inflammatory medicine as well.

Center for Joint Regeneration also offers stem cell procedures for joint arthritis, ligament injuries and tendonitis of other areas of the body as well. This helps patients avoid surgery as well as helping athletes return to sporting activities.

For more information and scheduling to discuss regenerative medicine stem cell procedure options, call (480) 466-0980.

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Center for Joint Regeneration in Phoenix Now Offering Stem Cell Procedures for Nonoperative Rotator Cuff Tendon Repair

State stem cell agencys at a crossroads – Business …

By Stell Cell Research

In a few days, the $3 billion California stem cell agency is slated to pick a new president who will oversee what could be the last years of its life.

The governing board of the California Institute of Regenerative Medicine (CIRM), as the agency is formally known, is scheduled to make the decision Wednesday on the new CEO and his or her pay, which may top $500,000 annually and predictably stir public outrage.

It is a watershed moment for the nearly 10-year-old agency. Not only does it need a new president, it needs more cash, along with results that will resonate widely with the public and potential funding sources. Money for new research awards is scheduled to run out in 2017. To help build support and attract cash, CIRM has begun an aggressive push to commercialize stem cell research. The hope is to fulfill the promises of cures that were made during the ballot initiative campaign that created the program in 2004.

Overall, the agency, which has 56 employees, has handed out about $1.7 billion since it was created by California voters when they approved Proposition 71. The measure funded the agency directly from state borrowing (bonds), with no intervention by the governor or Legislature. No cures have yet resulted from CIRMs spending.

The agencys new chief will replace scientist Alan Trounson, who said last fall that he was resigning to rejoin his family in Australia. Trounson was hired in 2008 at an annual salary of $490,008, where it remains today.

Late last year, the agency pointedly specified that the new CEO did not have to be a scientist. Hiring someone from the private sector, however, could mean offering a salary higher than Trounsons.

The new president and the agency face other issues, particularly developing what the agency calls a sustainability plan that would finance it beyond 2017. CIRM Chairman Jonathan Thomas is examining the possibility of a public-private partnership and is pitching the agencys achievements to possible funding sources.

Asked last week to summarize CIRMs accomplishments, Thomas said in an email, In just a few short years we didnt start funding research in earnest until 2007 we have helped make California the world leader in stem cell research and advanced the science much faster than anyone imagined would happen. Just 10 years after the passage of Proposition 71, 10 projects (that) we have funded are in or have been in clinical trials including therapies for heart failure and HIV/AIDS and we anticipate several more in cancer, diabetes, sickle cell disease and blindness going into clinical trials this year. Its a record the people of California can be proud of.

CIRMs message, however, did not resonate at a meeting in January of the only state body charged with oversight of the enterprise the Citizens Financial Accountability Oversight Committee, which is chaired by state Controller John Chiang.

One member of the committee, Jim Lott, a hospital industry executive in the Los Angeles area and backer of Proposition 71, was sharply critical of a presentation by Thomas and Ellen Feigal, CIRMs senior vice president for research and development. According to the transcript of the meeting, Lott said, What can you tell me that weve done thats going to get my (13-year-old) daughter out of her wheelchair sooner (rather) than later after all this money has been spent?

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State stem cell agencys at a crossroads - Business ...

Vet-Stem, Inc. Licenses Its New Patent to Human Stem Cell Company

By Stem Cell Medicine

Poway, California (PRWEB) April 24, 2014

Vet-Stem, Inc., announced that a non-exclusive European license agreement has been signed with a global human stem cell company. This license provides access to the newly issued Vet-Stem patent for the extraction methods and the use of adipose-derived stem cells in prevention and treatment of diseases in the human. Vet-Stem retains all rights outside of the human field.

As the first and largest company in the world to offer fat-derived stem cell services for veterinary use, Vet-Stem has rapidly developed the market, treating over 10,000 horses and dogs. In its veterinary development, Vet-Stem has collaborated closely with leading companies and academic institutions worldwide involved in bringing this technology to the human markets. Vet-Stems patent covers both veterinary and human applications and it seeks to license the human applications to additional interested companies.

Intellectual property rights can be confusing in a rapidly developing market with evolving technology, said Bob Harman, DVM, MPVM, CEO of Vet-Stem. We have in-licensed the strongest patents in the world to protect the market that we are creating in regenerative veterinary medicine and to ensure that the value of the company is optimized. Now with this additional patent issued directly to Vet-Stem, we can collaborate directly with companies developing human therapeutics in the cell therapy space.

Vet-Stem currently offers stem cell services to veterinarians for treatment of lameness in horses and for arthritis in dogs and cats. New uses of regenerative cells are in development for diseases in dogs, cats and horses that often times have few other treatment options.

About Vet-Stem, Inc. Vet-Stem, Inc. was formed in 2002 to bring regenerative medicine to the veterinary profession. The privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem, Inc. pioneered the use of regenerative stem cells in veterinary medicine. The company holds exclusive licenses to over 50 patents including world-wide veterinary rights for use of adipose derived stem cells. In the last decade over 10,000 animals have been treated using Vet-Stem, Inc.s services, and Vet-Stem is actively investigating stem cell therapy for immune-mediated and inflammatory disease, as well as organ disease and failure. For more on Vet-Stem, Inc. and Veterinary Regenerative Medicine visit http://www.vet-stem.com or call 858-748-2004.

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Vet-Stem, Inc. Licenses Its New Patent to Human Stem Cell Company

Skin Layer Grown From Human Stem Cells Could Replace Animals In Drug, Cosmetics Testing

By Stem Cell Medical Center

April 25, 2014

Kings College London

An international team led by Kings College London and the San Francisco Veteran Affairs Medical Center (SFVAMC) has developed the first lab-grown epidermis the outermost skin layer with a functional permeability barrier akin to real skin. The new epidermis, grown from human pluripotent stem cells, offers a cost-effective alternative lab model for testing drugs and cosmetics, and could also help to develop new therapies for rare and common skin disorders.

The epidermis, the outermost layer of human skin, forms a protective interface between the body and its external environment, preventing water from escaping and microbes and toxins from entering. Tissue engineers have been unable to grow epidermis with the functional barrier needed for drug testing, and have been further limited in producing an in vitro (lab) model for large-scale drug screening by the number of cells that can be grown from a single skin biopsy sample.

The new study, published in the journal Stem Cell Reports, describes the use of human induced pluripotent stem cells (iPSC) to produce an unlimited supply of pure keratinocytes the predominant cell type in the outermost layer of skin that closely match keratinocytes generated from human embryonic stem cells (hESC) and primary keratinocytes from skin biopsies. These keratinocytes were then used to manufacture 3D epidermal equivalents in a high-to-low humidity environment to build a functional permeability barrier, which is essential in protecting the body from losing moisture, and preventing the entry of chemicals, toxins and microbes.

A comparison of epidermal equivalents generated from iPSC, hESC and primary human keratinocytes (skin cells) from skin biopsies showed no significant difference in their structural or functional properties compared with the outermost layer of normal human skin.

Dr Theodora Mauro, leader of the SFVAMC team, says: The ability to obtain an unlimited number of genetically identical units can be used to study a range of conditions where the skins barrier is defective due to mutations in genes involved in skin barrier formation, such as ichthyosis (dry, flaky skin) or atopic dermatitis. We can use this model to study how the skin barrier develops normally, how the barrier is impaired in different diseases and how we can stimulate its repair and recovery.

Dr Dusko Ilic, leader of the team at Kings College London, says: Our new method can be used to grow much greater quantities of lab-grown human epidermal equivalents, and thus could be scaled up for commercial testing of drugs and cosmetics. Human epidermal equivalents representing different types of skin could also be grown, depending on the source of the stem cells used, and could thus be tailored to study a range of skin conditions and sensitivities in different populations.

Source: King's College London

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Skin Layer Grown From Human Stem Cells Could Replace Animals In Drug, Cosmetics Testing

Stem Cells Yield Lab-Grown Skin, Researchers Say

By Stem Cell Medical Center

Posted: Friday, April 25, 2014, 9:00 AM

FRIDAY, April 25, 2014 (HealthDay News) -- Skin that was created from stem cells and grown in a lab could be used instead of animals to test drugs and cosmetics, and to develop new treatments for skin disorders, scientists report.

An international team of researchers said it's the first to create lab-grown epidermis -- the outermost layer of skin -- that has a functional barrier like real skin. The functional barrier prevents water from escaping the body and keeps germs and toxins out. Until now, no one had successfully grown epidermis with a functional barrier, which is needed for drug testing, the study authors said.

The research, led by scientists at King's College London and the San Francisco Veteran Affairs Medical Center, is described in the current issue of the journal Stem Cell Reports.

The ability to create an unlimited amount of genetically identical skin samples "can be used to study a range of conditions where the skin's barrier is defective due to mutations in genes involved in skin barrier formation, such as ichthyosis (dry, flaky skin) or atopic dermatitis (eczema)," Dr. Theodora Mauro, leader of the research team, said in a King's College London news release.

"We can use this model to study how the skin barrier develops normally, how the barrier is impaired in different diseases and how we can stimulate its repair and recovery," she said.

Dr. Dusko Ilic, leader of the team at King's College London, said: "Our new method can be used to grow much greater quantities of lab-grown human epidermal equivalents, and thus could be scaled up for commercial testing of drugs and cosmetics."

"Human epidermal equivalents representing different types of skin could also be grown, depending on the source of the stem cells used, and could thus be tailored to study a range of skin conditions and sensitivities in different populations," he added.

More information

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Stem Cells Yield Lab-Grown Skin, Researchers Say

Okla. House passes abortion clinic standards bill

By Stem Cell Clinic

OKLAHOMA CITY (AP) - A bill that would impose strict new state regulations and requirements on abortion providers in Oklahoma easily won the approval of the state House on Thursday.

The legislation would require the Oklahoma Board of Health to establish standards regarding equipment and supplies that might be needed in a medical emergency. Abortion clinics would also be required to have a physician with admitting privileges at a nearby hospital present when an abortion is performed.

The measure has already passed the Senate. House members voted 75-15 for it after amending the bill to also ban stem cell research in the state, similar to personhood legislation that House leaders refused to hear two years ago.

The bill now returns to the Senate for consideration of the amendment.

One of two physicians who serve in the chamber said Thursday that the Board of Health, which has nonphysician members, is not an appropriate agency to set medical standards.

The state Board of Health has no business determining medical procedures. The medical profession sets those standards, said Rep. Doug Cox, R-Grove, an emergency room physician. A medical expert could be a physical therapist. Thats a dangerous precedent.

Rep. Cory Williams, D-Stillwater, said the bill could have a devastating effect on the entire practice of medicine, not just abortion access.

Logic and reason really dont have that much of a place around here, Williams said.

The bills author, Rep. Randy Grau, R-Edmond, said it will require abortion clinics to be equipped and staffed to deal with a medical emergency if an abortion occurs.

I dont have a problem holding them to a higher standard, Grau said.

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Okla. House passes abortion clinic standards bill

Annual Wisconsin Stem Cell Symposium to focus on blood

By Stem Cell Medical Center

World stem cell leaders will converge on Promega's BioPharmaceutical Technology Center in Fitchburg, Wisconsin, on April 30 for the 9th Annual Wisconsin Stem Cell Symposium: From Stem Cells to Blood.

Coordinated by the nonprofit BioPharmaceutical Technology Center Institute, the University of Wisconsin-Madison Stem Cell and Regenerative Medicine Center and the UW-Madison Blood Research Program, this year's symposium is focused on how the stem cells that give rise to blood develop and function. It will also look at the diversity of insights stem cell studies have provided other fields.

Highlighted topics include genesis and regulation of progenitor cells and hematopoietic stem cells, stem cell genomes/epigenomes, stem cell microenvironment, and tumor initiating cells.

The day will be broken up into four moderated sessions focused on various themes, including:

Featured speakers include Scott A. Armstrong, Grayer Family Chair and vice chair for basic and translational research in the Department of Pediatrics at Memorial Sloan Kettering Cancer Center in New York; Berthold Gttgens, professor of molecular hematology at the Cambridge Institute for Medical Research, University of Cambridge in the United Kingdom; and Nancy A. Speck, professor in the Department of Cell and Molecular Biology and principal investigator in the University of Pennsylvania Perelman School of Medicine, Abramson Family Cancer Research Institute.

The day begins at 7 a.m. with registration and a continental breakfast and closes with a reception from 5 until 6 p.m. Registration for the public event is $45 for students and postdoctoral researchers, $90 for all others.

In addition to the symposium's coordinators, platinum sponsors of the event include Promega Corp., Perkins Coie and the WiCell Research Institute.

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Annual Wisconsin Stem Cell Symposium to focus on blood

Blood cancer patients have local option for marrow transplants

By Stem Cell Medical Center

by JIM BERGAMO / KVUE News and editor Rob Diaz

kvue.com

Posted on April 22, 2014 at 5:14 PM

Updated Tuesday, Apr 22 at 7:00 PM

AUSTIN -- Doctors at St. Davids South AustinMedical Center recently performed the first adult hematopoieticstem cell transplant, which is a type of blood and marrowtransplant. Prior to the new comprehensive blood cancer center,patients had to leave Austin to get the treatment they needed.

Earlier this year, Nancy Guerra enjoyed some down time at her Northwest Austin home, putting together an electronic puzzle. But her own health became far more puzzling than anything she could piece together on her I-Pad. She suffered from multiple myeloma and had intense chemotherapy treatments in preparation for a more important procedure.

Doing the chemotherapy is really good, said Guerra. It puts me in remission, but Im not going to stay in remission anywhere near as long as I will when I have a bone marrow transplant.

But like other patients with bone cancer disorders where to go to get that blood marrow is the key question.

Austin is reaching a critical mass size, said David Huffstutler, President and Chief Executive Officer, St. Davids HealthCare. While we already have a wide array of oncology services, bone marrow transplantation was a missing piece.

Until now Central Texas patients had to travel to San Antonio or Dallas for transplants. The procedure takes only a few hours, but it can take several months for the bone marrow transition to be completed. For Guerra, leaving Austin for that length of time was simply out of the question. So in February she became the first patient to receive a transplant at the new, comprehensive blood cancer center at St. Davids South Austin Medical Center.

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Blood cancer patients have local option for marrow transplants

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