BBC News

Edinburgh firm Angel Biotechnology buys collagen plant BBC News Biopharmaceutical firm Angel Biotechnology has bought a collagen manufacturing facility in Glasgow as it seeks to expand its core business. The purchase was undertaken by Angel's newly-formed and wholly-owned subsidiary, Angel Biomedical Ltd (ABL). Angel Biotechnology planning to expand operationnebusiness.co.uk all 2 news articles »

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LA Weekly (blog)

Black Licorice Found to Fight Diabetes LA Weekly (blog) A research team at the Max Planck Institute for Molecular Genetics in Berlin, has identified a group of natural substances in licorice root called amorfrutins. Using a mouse model, the scientists found that amorfrutins reduce blood sugar levels and ... and more »

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"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM) for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

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http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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 "Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

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By Andrew Beam abeam@troyrecord.com Twitter.com/beam_record

Ryan Gilbert, assistant professor of biomedical engineering at Rensselaer Polytechnic Institute and G.E. Washington, visiting assistant professor of art at The College of Saint Rose, stand under an inflated sculpture of a ganglion knot created as a result of their unique collaboration inside RPIs Center for Biotechnology and Interdisciplinary Studies in Troy Friday. (J.S. Carras/The Record)

TROY A professor and scientist from Rensselaer Polytechnic Institute and a visiting professor of art from the College of Saint Rose were both taken out of their comfort zones to create artistic and educational works based on research being conducted into stem cell technologies and the repair of spinal cord injuries.

The exhibit, titled A Walk Through the Nervous System: Artists View of Nerves and Spinal Cord Injury opened Friday with the hope of making it easier for the community at large to better comprehend not only how nerves work but also how injures affect the spinal cord.

Dr. Ryan Gilbert, an assistant professor in the Department of Biomedical Engineering at RPI, received a $500,000 grant from the National Science Foundation, $10,000 to $20,000 of which is earmarked for community awareness and outreach. The remainder of the grant funds the research Gilbert and his colleagues are conducting in the departments laboratories.

Gilbert said the department is working with biomaterials on both a nano and micro scale, and in the future hopes to implant them into the spinal cord to regenerate it. Currently, Gilbert explained, when someone injures his or her spinal cord, there is not only the potential for paralysis, but also for permanent damage, as no cure exists yet.

To show exactly what materials Gilbert and his colleagues are working with, department head Deepak Vashishth reached out to Washington, a visiting assistant professor of art at the College of Saint Rose, and his colleagues to help create pieces of art to represent them.

Washington said he spoke with Gilbert about the project. After listening to Gilbert explain some of the materials he was working with and realizing the interest he had in what he was doing, Washington himself became more interested in the project.

Its very interesting and sexy work, Washington said.

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Scientist, artist collaborate on exhibit about spinal cord injuries

11-05-2012 14:16 Stem cells are the body's repair cells. They have the ability to divide and differentiate into many different types of cells based on where they are needed throughout the body. Stem cells can divide and turn into tissues such as skin, fat, muscle, bone, cartilage, and nerve to name a few. With this capability, we can use them as a treatment for joint injuries, ligament and tendon damage, and fractured bones. Using MediVet America's Stem Cell Therapy, we have seen positive clinical improvement in 95% of the arthritic cases performed nationwide. Some owners have even reported seeing a difference in as little as a week!

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Stem Cell Therapy Exclusively at Gandy Animal Hospital - Tampa, FL - Video

Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

Original post:
In The Know: Stem cell therapy

ROCKVILLE, Md., May 9, 2012 /PRNewswire/ -- Neuralstem, Inc. (CUR) today reported its financial results for the three months ended March 31, 2012 and provided a business and clinical update.

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

"In the first Quarter of 2012, we entered the final cohort of our Phase I clinical trial in ALS at Emory University Hospital. We are encouraged with the recent approval by the FDA to amend the trial protocol to bring back previously transplanted patients for additional dosing. These patients, who have each received ten lumbar injections earlier in the trial, may now receive an additional five cervical injections. These three patients in our ALS Phase I trial will become the first patients to receive neural stem cell injections up the full length of the spinal cord," said Karl Johe, PhD, chairman of the board and chief scientific officer of Neuralstem, Inc. "These patients are currently 15 to 17 months out from their original surgeries, so we are further encouraged by the fact that their disease progression has been slow enough that they can still be considered for these additional cervical injections. These segments of the spinal cord control breathing, and we believe that multiple injections in the cervical region may be the most effective way to help ALS patients. In order to be eligible, these three patients must meet the same inclusion criteria as new patients into the trial both before and at the time of surgery."

Dr. Johe continued, "This year will also see the start and finish of our neuroregenerative small molecule NSI-189 Phase Ib trial to treat major depressive disorder. This is a novel orally active drug that stimulates new neuron growth in the hippocampus which we believe can help patients with major depressive disorder. We are finalizing the preparations for the first of three cohorts of eight patients each that are scheduled to demonstrate the safety of escalating doses of daily administration of NSI-189 during a 28-day cycle. Dr. Maurizio Fava of Harvard University and Massachusetts General helped to design the trial and we thank him for his efforts.

"Internationally, we expect to commence a combined Phase I/II/III clinical trial for chronic motor disorders from stroke at BaYi Brain Hospital in Beijing through our wholly owned subsidiary, Neuralstem China later in the year. We are currently engaged in test runs at our facility in Suzhou, China where we will manufacture the neural stem cells for the trial," concluded Dr. Johe.

Neuralstem's President and CEO Richard Garr added, "This New Year has seen us actively engaged in licensing discussions for our proprietary surgical device, invented by our ALS surgeon, Dr. Nicholas M. Boulis, with both the industry and Academia. We believe it will be the industry standard for such intraspinal procedures.

"We continue to work with our partner Sumitomo's Summit Pharmaceuticals International Corporation with the goal of licensing NSI-189 to a Japanese pharmaceutical company for development of the Japanese market this year," Mr. Garr continued. "We also continue to see strong interest in co-development opportunities for our preclinical library of additional patented novel neuroregenerative compounds. The company is committed to finding the right partner to move these preclinical compounds forward."

Clinical Program and Business Highlights

Cellular Therapy: Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University Hospital

Corporate News

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Neuralstem Reports First Quarter Financial Results And Provides Business And Clinical Update

NEWARK Stem cells might repair damage in a spinal cord, regenerating tissue currently considered irreparable. Electrical implants are already allowing a quadriplegic to control a robotic hand with their thoughts. And scientists are working on protein therapy that would keep a bad injury from becoming catastrophic .

These were just some of the advances in treating spinal cord injuries that were heralded at a symposium Wednesday at the University of Medicine and Dentistry of New Jersey. It was the second annual meeting of national scientists and researchers coming together in Newark to sharing their expertise.

The presentations show further advances since last years inaugural event, according to the experts.

"Everything Im seeing here is completely different than what I learned as a medical student 25 years ago," said Robert Heary, a UMDNJ neurosurgeon, the co-director of the Reynolds Family Spine Laboratory at the Spine Center of New Jersey, and the organizer of the event.

Stem cell implantation in a dozen spinal-cord patients is underway in Switzerland, according to Aileen Anderson, an associate professor of physical medicine and rehabilitation at the University of California-Irvine who has been involved in the work. She said the human clinical trial involving multipotent cells at the University of Zurich will be going through 2015 at least but stem cells advances have been moving relatively quickly.

"Cholesterol drugs took 30 years to get to market," Anderson said. "Stem cells as potential therapeutics have moved pretty quickly."

Some of the work presented variations upon a microscopic theme.

A UMDNJ team presented work in which an immune-system protein is suppressed to reduce inflammation allowing better recovery after catastrophic injury in mice. Michele Basso, a professor at the Ohio State University College of Medicine, presented work that showed rodents walking was dramatically improved after the another protein was suppressed, and they got exercise.

"We begin to see a gain of function that we wouldnt normally see," said Basso.

Still others focused on the technologies that being used to currently treat patients.

See the article here:
UMDNJ symposium heralds advances in treating spinal cord injuries

NEWARK, Calif., May 9, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced that Armin Curt, MD, FRCPC, Professor and Chairman, Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the Balgrist University Hospital and principal investigator for the Company's Phase I/II clinical trial in chronic spinal cord injury, will provide a progress report on the trial on Thursday, May 17 at the Interdependence 2012 Global SCI Conference. Interdependence 2012, which is being held in Vancouver, British Columbia on May 15-17, 2012, is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.

In addition, on Thursday, May 17, Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc., will make a presentation on neural stem cell transplantation in neurological disorders. Dr. Huhn will describe the scientific and preclinical rationale for the Company's extensive clinical development program which encompasses all three elements of the central nervous system -- spinal cord, brain, and eye. StemCells was the first company to receive authorizations from the US Food and Drug Administration and Swissmedic to conduct clinical trials to evaluate purified human neural stem cells as potential therapeutic agents.

The goal of Interdependence 2012 is to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research.

About the Spinal Cord Injury Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.

The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. For information on patient enrollment, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at stemcells.pz@balgrist.ch.

Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.

About Balgrist University Hospital

Balgrist University Hospital, University of Zurich is recognized worldwide as a highly specialized center of excellence providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions. The clinic owes its leading international reputation to its unique combination of specialized medical services. The hospital's carefully-balanced, interdisciplinary network brings together under one roof medical specialties including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology, and physical medicine. More information about Balgrist University Hospital is available at http://www.balgrist.ch.

The rest is here:
StemCells, Inc. to Provide Progress Report on Spinal Cord Injury Trial at the Interdependence 2012 Global SCI ...

University of Michigan Hospital (Credit: UM.edu)

ANN ARBOR Three patients with amyotrophic lateral sclerosis will be permitted to receive a second dose of stem cells delivered directly to the spinal cord, in a clinical trial being led by the University of Michigans Eva Feldman, M.D.

The U.S. Food and Drug Administration approved the second treatment after a review concluded that the patients showed no adverse effects from their first implantation surgeries.

All have ALS, the inevitably fatal degenerative disease of the nervous system that many call Lou Gehrigs disease. They received injections directly into the lumbar, or lower, area of the spinal cord.

None of the patients experienced any long-term complications related to either the surgical procedure or the implantation of stem cells, or showed signs of rejecting the cells. And in the months following the surgery to inject the cells, none showed evidence that their ALS progression was accelerating.

These patients will receive a second implantation to the cervical, or upper, region of the spine where the nerves that control breathing reside. Most ALS patients die of respiratory failure as these nerves die or are damaged by the disease.

We believe that the cells and the route of administration are safe, said Feldman, principal investigator of the trial and the director of the UMs A. Alfred Taubman Medical Research Institute. The FDA go-ahead to bring these three patients back for re-dosing is a further validation of that.

The trial is funded by Neuralstem, to which Feldman is an unpaid consultant.

This Phase 1 safety trial, which is taking place at Emory University in Atlanta, began in January 2010. After reviewing safety data from the first 12 patients, the FDA granted approval for the trial to advance the cervical injections. Three patients so far have received injections to that area. Those to be re-dosed will come from the first cohort of 12.

Results from that cohort recently were featured in the peer-reviewed journal Stem Cells in an article authored by Feldman and her colleagues at Emory, including neurologist Jonathan Glass, M.D. and neurosurgeon Nick Boulis, M.D., who performed the implantation surgeries. Boulis, an adjunct professor at UMs Medical School and a Taubman Scholar, also developed the device used to inject the stem cells into the spinal cord, which received a notice of patent allowance from U.S. Patent and Trademark Office in October.

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ALS Patients Approved For More Stem Cells

MONT-SAINT-GUIBERT, Belgium, May 9, 2012 /PRNewswire/ --

The Belgian biotechnology company, Cardio3--BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases, today announces that it has received CE Marking (Conformit Europenne) for its intra-myocardial C-Cath Injection Catheter. The CE Mark certifies that C-Cath complies with applicable European health, safety and environmental protection legislation. C-Cath is now available for commercial use in the EU and many other countries where the CE mark allows commercialization.

The C-Cath Injection Catheter is the most advanced device of its kind and was designed to address three key requirements: ease of use, safety and efficacy. During its development Cardio3 BioSciences combined its extensive experience in stem cell therapies and specific knowledge of the properties of heart tissue with key insights from leading cardiologists in the field. C-Cath's performance is based on its unique needle design as well as unique catheter properties. Previously announced pre-clinical data from a head to head comparison with the 'best' injection catheter available until now showed a close to threefold increase in retention of stem cells within the heart muscle in favour of the CCath Injection Catheter. Within a clinical setting, an increased retention rate could allow an increase in efficacy while reducing side effects.-

Dr Christian Homsy,CEOof Cardio3-BioSciences comments on today's announcement: "Today marks an important milestone for Cardio3 BioSciences and our innovative C-Cath technology. With C-Cath, we developed an advanced injection catheter that meets the requirements of physicians and has the potential to deliver better outcomes for patients. C-Cath demonstrates our commitment to continued innovation in regenerative heart therapy. This is a major step forward in addressing the patient needs for regenerative therapies for the heart and provides physicians with new treatment options."

About Cardio3 BioSciences

Cardio3-BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3-BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.

The Company's lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3-BioSciences has developed C-Cath, the next-generation injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.

C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities. As a result, of these factors investors and prospective investors are cautioned not to rely on any forward-looking statements.We disclaim any intention or obligation to update or review any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information contact:

Cardio3 BioSciences http://www.c3bs.com

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Cardio3 BioSciences Announces CE Marking for its C-Cath® Injection Catheter

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR)has announced that a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating has seen a reversal of her condition. The improvement came due to a significant increase in her red cells, white cells and platelets following the intramuscular injection of Pluristem's PLacental eXpanded (PLX) cells. Aplastic bone marrow is a disease where the patient has no blood-forming hematopoietic stem cells in the bone marrow.

Hadassah Medical Center Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center director Prof. Reuven Or said, "With her body rejecting all possible treatment, and with no other options, we finally turned to Pluristem's PLX cells, which literally saved her life. The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."

The patient has been hospitalized at the Hadassah Hebrew University Medical Center in Jerusalem since August 2011. Her aplastic bone marrow had been refractory to treatment. So she underwent allogeneic stem cell transplantation from a matched unrelated donor. The first transplant was unsuccessful and the patient remained with bone marrow failure. The patient underwent a second allogeneic stem cell transplantation from a second donor. The bone marrow function was very poor and the patient suffered from recurrent infections.

Two months after the patient's second bone marrow transplant, the child received PLX cells intramuscularly in two doses about one week apart. Some 10 days after the last administration of PLX cells, the patient's hematological parameters began to significantly increase, an effect that has persisted to date. The patient's general clinical status has also improved. Subsequent analysis has indicated that the PLX cells worked by stimulating the recovery of the hematopoietic stem cells contained in the second bone marrow transplant that she had received over two months earlier. Finally, after nine months of hospitalization, the child will be discharged from the hospital.

Pluristem chairman and CEO Zami Alberman said, "Pluristem is extremely happy that our PLX cells have helped this little girl. Remarkably, these beneficial effects were seen in the patient after our PLX cells were administered intramuscularly and correlate with the positive effects on the bone marrow when we administered our PLX cells intramuscularly (IM) in animals exposed to toxic levels of radiation. Pluristem now has several data points to indicate that our PLX cells may work for systemic diseases when given locally, away from the target organ, and without a need to give cells intravenously."

In February 2012, Pluristem announced the results of animal studies suggesting PLX cells can be potentially effective in treating the life threatening hematopoietic complications associated with Acute Radiation Syndrome (ARS). In these experiments, animals given PLX cells IM up to 24 hours post irradiation demonstrated a recovery of their red cells, white cells, platelets and bone marrow to almost normal levels. It was that announcement, and the significant deterioration of the patient following two bone marrow transplants, that led Prof. Or to contact Pluristem about the possible compassionate use of PLX cells to treat his young patient.

Pluristem recently received US FDA clearance to begin a Phase II clinical trial using the company's proprietary PLX-PAD cell product candidate intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

Published by Globes, Israel business news - http://www.globes-online.com - on May 9, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem stem cells save girl's life

ScienceDaily (May 9, 2012) For the first time, scientists at Fred Hutchinson Cancer Research Center have transplanted brain cancer patients' own gene-modified blood stem cells in order to protect their bone marrow against the toxic side effects of chemotherapy. Initial results of the ongoing, small clinical trial of three patients with glioblastoma showed that two patients survived longer than predicted if they had not been given the transplants, and a third patient remains alive with no disease progression almost three years after treatment.

"We found that patients were able to tolerate the chemotherapy better and without negative side effects after transplantation of the gene-modified stem cells than patients in previous studies who received the same type of chemotherapy without a transplant of gene-modified stem cells," said Hans-Peter Kiem, M.D., senior and corresponding author of the study published in the May 9 issue of Science Translational Medicine.

Kiem, a member of the Clinical Research Division at the Hutchinson Center, said that a major barrier to effective use of chemotherapy to treat cancers like glioblastoma has been the toxicity of chemotherapy drugs to other organs, primarily bone marrow. This results in decreased blood cell counts, increased susceptibility to infections and other side effects. Discontinuing or delaying treatment or reducing the chemotherapy dose is generally required, but that often results in less effective treatment.

In the current study, Kiem and colleagues focused on patients with glioblastoma, an invariably fatal cancer. Many of these patients have a gene called MGMT (O6-methylguanine-DNA-methyltransferase) that is turned on because the promoter for this gene is unmethylated. MGMT is a DNA repair enzyme that counteracts the toxic effect of some chemotherapy agents like temozolomide. Patients with such an unmethylated promoter status have a particularly poor prognosis.

A drug called benzylguanine can block the MGMT gene and make tumor cells sensitive to chemotherapy again, but when given with chemotherapy, the toxic effects of this combination are too much for bone marrow cells, which results in marrow suppression.

By giving bone marrow stem cells P140K, which is a modified version of MGMT, those cells are protected from the toxic effects of benzylguanine and chemotherapy, while the tumor cells are still sensitive to chemotherapy. "P140K can repair the damage caused by chemotherapy and is impervious to the effects of benzylguanine," Kiem said.

"This therapy is analogous to firing at both tumor cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumor cells are unshielded," said Jennifer Adair, Ph.D., who shares first authorship of the study with Brian Beard, Ph.D., both members of Kiem's lab.

The three patients in this study survived an average of 22 months after receiving transplants of their own circulating blood stem cells. One, an Alaskan man, remains alive 34 months after treatment. Median survival for patients with this type of high-risk glioblastoma without a transplant is just over a year.

"Glioblastoma remains one of the most devastating cancers with a median survival of only 12 to 15 months for patients with unmethylated MGMT," said Maciej Mrugala, M.D., the lead neuro oncologist for this study.

As many as 50 percent to 60 percent of glioblastoma patients harbor such chemotherapy-resistant tumors, which makes gene-modified stem cell transplant therapy applicable to a large number of these patients. In addition, there are also other brain tumors such as neuroblastoma or other solid tumors with MGMT-mediated chemo resistance that might benefit from this approach.

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Gene-modified stem cell transplant protects patients from toxic side effects of chemotherapy, study suggests

Public release date: 9-May-2012 [ | E-mail | Share ]

Contact: Dean Forbes dforbes@fhcrc.org 206-667-2896 Fred Hutchinson Cancer Research Center

SEATTLE For the first time, scientists at Fred Hutchinson Cancer Research Center have transplanted brain cancer patients' own gene-modified blood stem cells in order to protect their bone marrow against the toxic side effects of chemotherapy. Initial results of the ongoing, small clinical trial of three patients with glioblastoma showed that two patients survived longer than predicted if they had not been given the transplants, and a third patient remains alive with no disease progression almost three years after treatment.

"We found that patients were able to tolerate the chemotherapy better and without negative side effects after transplantation of the gene-modified stem cells than patients in previous studies who received the same type of chemotherapy without a transplant of gene-modified stem cells," said Hans-Peter Kiem, M.D., senior and corresponding author of the study published in the May 9 issue of Science Translational Medicine.

Kiem, a member of the Clinical Research Division at the Hutchinson Center, said that a major barrier to effective use of chemotherapy to treat cancers like glioblastoma has been the toxicity of chemotherapy drugs to other organs, primarily bone marrow. This results in decreased blood cell counts, increased susceptibility to infections and other side effects. Discontinuing or delaying treatment or reducing the chemotherapy dose is generally required, but that often results in less effective treatment.

In the current study, Kiem and colleagues focused on patients with glioblastoma, an invariably fatal cancer. Many of these patients have a gene called MGMT (O6-methylguanine-DNA-methyltransferase) that is turned on because the promoter for this gene is unmethylated. MGMT is a DNA repair enzyme that counteracts the toxic effect of some chemotherapy agents like temozolomide. Patients with such an unmethylated promoter status have a particularly poor prognosis.

A drug called benzylguanine can block the MGMT gene and make tumor cells sensitive to chemotherapy again, but when given with chemotherapy, the toxic effects of this combination are too much for bone marrow cells, which results in marrow suppression.

By giving bone marrow stem cells P140K, which is a modified version of MGMT, those cells are protected from the toxic effects of benzylguanine and chemotherapy, while the tumor cells are still sensitive to chemotherapy. "P140K can repair the damage caused by chemotherapy and is impervious to the effects of benzylguanine," Kiem said.

"This therapy is analogous to firing at both tumor cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumor cells are unshielded," said Jennifer Adair, Ph.D., who shares first authorship of the study with Brian Beard, Ph.D., both members of Kiem's lab.

The three patients in this study survived an average of 22 months after receiving transplants of their own circulating blood stem cells. One, an Alaskan man, remains alive 34 months after treatment. Median survival for patients with this type of high-risk glioblastoma without a transplant is just over a year.

Read more:
Gene-modified stem cell transplant protects patients from toxic side effects of chemotherapy

Study is first to show feasibility and efficacy of a new use for autologous stem cell transplant

Newswise SEATTLE For the first time, scientists at Fred Hutchinson Cancer Research Center have transplanted brain cancer patients own gene-modified blood stem cells in order to protect their bone marrow against the toxic side effects of chemotherapy. Initial results of the ongoing, small clinical trial of three patients with glioblastoma showed that two patients survived longer than predicted if they had not been given the transplants, and a third patient remains alive with no disease progression almost three years after treatment.

We found that patients were able to tolerate the chemotherapy better and without negative side effects after transplantation of the gene-modified stem cells than patients in previous studies who received the same type of chemotherapy without a transplant of gene-modified stem cells, said Hans-Peter Kiem, M.D., senior and corresponding author of the study published in the May 9 issue of Science Translational Medicine.

Kiem, a member of the Clinical Research Division at the Hutchinson Center, said that a major barrier to effective use of chemotherapy to treat cancers like glioblastoma has been the toxicity of chemotherapy drugs to other organs, primarily bone marrow. This results in decreased blood cell counts, increased susceptibility to infections and other side effects. Discontinuing or delaying treatment or reducing the chemotherapy dose is generally required, but that often results in less effective treatment.

In the current study, Kiem and colleagues focused on patients with glioblastoma, an invariably fatal cancer. Many of these patients have a gene called MGMT (O6-methylguanine-DNA-methyltransferase) that is turned on because the promoter for this gene is unmethylated. MGMT is a DNA repair enzyme that counteracts the toxic effect of some chemotherapy agents like temozolomide. Patients with such an unmethylated promoter status have a particularly poor prognosis.

A drug called benzylguanine can block the MGMT gene and make tumor cells sensitive to chemotherapy again, but when given with chemotherapy, the toxic effects of this combination are too much for bone marrow cells, which results in marrow suppression.

By giving bone marrow stem cells P140K, which is a modified version of MGMT, those cells are protected from the toxic effects of benzylguanine and chemotherapy, while the tumor cells are still sensitive to chemotherapy. P140K can repair the damage caused by chemotherapy and is impervious to the effects of benzylguanine, Kiem said.

This therapy is analogous to firing at both tumor cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumor cells are unshielded, said Jennifer Adair, Ph.D., who shares first authorship of the study with Brian Beard, Ph.D., both members of Kiems lab.

The three patients in this study survived an average of 22 months after receiving transplants of their own circulating blood stem cells. One, an Alaskan man, remains alive 34 months after treatment. Median survival for patients with this type of high-risk glioblastoma without a transplant is just over a year.

Glioblastoma remains one of the most devastating cancers with a median survival of only 12 to 15 months for patients with unmethylated MGMT, said Maciej Mrugala, M.D., the lead neuro oncologist for this study.

See the article here:
Transplanted Gene-Modified Blood Stem Cells Protect Brain Cancer Patients From Toxic Side Effects of Chemotherapy

LAS VEGAS, May 10, 2012 /PRNewswire/ -- An investigational therapyderived from a patient's own bone marrow stem cells improves heart function in some patients with progressive heart failure due to dilated cardiomyopathy (DCM), according to the results of a Phase 2a study presented today as a late-breaking clinical trial at the SCAI 2012 Scientific Sessions.

Ixmyelocel-T is developed by culturing a patient's bone marrow for 12 days to increase the numbers of immune cells including macrophages and monocytes, as well as mesenchymal cells, stem cells that can differentiate into several different cell types. The resulting cell treatment is then injected into the patient's heart muscles to encourage growth of new tissue and improve inflammation.

"An increasing number of patients have progressive heart failure due to dilated cardiomyopathy, even after treatment with drug therapy and surgical intervention," said Timothy Henry, MD, FSCAI, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and the study's principal investigator. "In this study, patients treated with ixmyelocel-T showed repair in damaged heart muscle and some reversal in heart failure symptoms."

The trial included 22 ischemic (IDCM) and non-ischemic (NIDCM) patients with a New York Heart Association (NYHA) heart failure class of III or IV, or moderate to severe heart failure, and a left ventricular ejection fraction of 30 percent or less, which is a measure of how much blood leaves the heart with each pump. Patients were randomized to receive an injection of the treatment into their heart muscles or to a control group, and were followed at 3, 6 and 12 months.

After 12 months, no procedural complications and no difference in adverse events were reported among patients who received the treatment and the control group. IDCM patients who received the cell treatment had a lower mean number of major adverse clinical events (0.33 compared to 1.67 in the control group). IDCM patients who received the treatment were more likely to see improvement in NYHA class, six-minute walking distance and ejection fraction, compared to NIDCM patients who received the treatment and those in the control group.

"Treatment with ixmyelocel-T was well-tolerated and patients who received the cell therapy showed improved symptoms after one year," said Dr. Henry. "The results provide a strong basis for a larger clinical trial of this treatment in patients with dilated cardiomyopathy."

The study was sponsored by Aastrom Biosciences.

Dr. Henry will present "Safety and Efficacy ofIxmyelocel-T, An Expanded Patient-Specific Mixed Cell Therapy, in Dilated Cardiomyopathy" on Thursday, May 10, 2012, in the Late-Breaking Clinical Trials Session beginning at 12:00 p.m. (Pacific Time).

About SCAI

Headquartered in Washington, D.C., the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's patient education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit http://www.scai.org or http://www.SecondsCount.org.

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Treatment with Ixmyelocel-T Shown to Improve Outcomes in Heart Failure Patients

(CBS News) Patients with brain cancer may face devastating side effects from chemotherapy, but a new study offers a possible solution: stem cells.

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The stem cells form a shield of sorts against the toxic side effects from chemo, according to the researchers behind the study. It was a small trial that involved only three patients with glioblastoma, the most aggressive and common form of a malignant brain tumor that's usually fatal.

Two of the patients survived longer than predicted with help from the stem cell treatment - an average of 22 months - and a third man from Alaska remains alive today with no disease progression almost three years following treatment.

How does it work?

Many patients with the deadly form of brain cancer possess a gene called MGMT. The MGMT gene is typically turned on and counters the effects from some chemotherapy agents, such as temozolomide, rendering them less effective. As such, people with such a gene often have a particularly poor prognosis.

A drug called benzylguanine can block the MGMT gene, thus making tumors more receptive to chemotherapy, but the combination of the drug and chemo are often too toxic for healthy bone marrow cells.

That's where the new stem cell treatment comes in. By combining bone marrow stem cells with a modified version of MGMT in the form of the new treatment, patients' cells were protected from the toxic effects of the cancer drugs and chemotherapy while keeping the tumor cells targeted.

"This therapy is analogous to firing at both tumor cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumor cells are unshielded," study author Dr. Jennifer Adair, a researcher at the Fred Hutchinson Cancer Research Center in Seattle, said in a news release.

Read more:
Stem cells boost brain tumor treatments for some patients, study finds

HAIFA, Israel, May 9, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (Nasdaq:PSTI - News) (TASE:PLTR) today announced that a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating is now experiencing a reversal of her condition with a significant increase in her red cells, white cells and platelets following the intramuscular injection of the company's PLacental eXpanded (PLX) cells. Aplastic bone marrow is a disease where the patient has no blood-forming hematopoietic stem cells in the bone marrow.

"With her body rejecting all possible treatment -- and with no other options -- we finally turned to Pluristem's PLX cells, which literally saved her life," said Professor Reuven Or, Director of Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center at Hadassah Medical Center and the child's physician. "The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."

The patient has been hospitalized at the Hadassah Hebrew University Medical Center, Jerusalem since August 2011. Her aplastic bone marrow had been refractory to treatment and, therefore, she underwent allogeneic stem cell transplantation from a matched unrelated donor. The first transplant was unsuccessful and the patient remained with bone marrow failure. Therefore, the patient underwent a second allogeneic stem cell transplantation from a second donor. Unfortunately, the bone marrow function was very poor and the patient suffered from recurrent infections. Approximately two months after the patient's second bone marrow transplant, the child received PLX cells intramuscularly in two doses approximately one week apart. Approximately 10 days after the last administration of PLX cells, the patient's hematological parameters began to significantly increase, an effect that has persisted to date. Additionally, the patient's general clinical status has improved. Subsequent analysis has indicated that the PLX cells worked by stimulating the recovery of the hematopoietic stem cells contained in the second bone marrow transplant that she had received over two months earlier. Finally, after nine months of hospitalization, the child will be discharged from the hospital.

"Pluristem is extremely happy that our PLX cells have helped this little girl," said Zami Aberman, Chairman and CEO of Pluristem. "Remarkably, these beneficial effects were seen in the patient after our PLX cells were administered intramuscularly and correlates with the positive effects on the bone marrow when we administered our PLX cells intramuscularly (IM) in animals exposed to toxic levels of radiation. Pluristem now has several data points to indicate that our PLX cells may work for systemic diseases when given locally, away from the target organ, and without a need to give cells intravenously."

In February 2012, Pluristem announced the results of animal studies suggesting PLX cells can be potentially effective in treating the life threatening hematopoietic complications associated with Acute Radiation Syndrome (ARS). In these experiments, animals given PLX cells IM up to 24 hours post irradiation demonstrated a recovery of their red cells, white cells, platelets and bone marrow to almost normal levels. It was that announcement, and the significant deterioration of the patient following two bone marrow transplants, that led Professor Reuven Or to contact Pluristem about the possible compassionate use of PLX cells to treat his young patient.

Pluristem recently received U.S. FDA Clearance to begin a Phase II clinical trial using the company's proprietary PLX-PAD cell product candidate intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). In April, the Company was awarded a $3.1 Million grant by the Israeli Government, which will be used to help fund R&D and clinical trials.

About Pluristem Therapeutics Inc.

Pluristem Therapeutics Inc. (Nasdaq:PSTI - News) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the use of PLX cells administered locally to treat systemic diseases and potentially obviating the need to use the intravenous route.

Data from two phase I/II studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-BMP for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.

Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities as well as strategic relationships with major research institutions.

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Compassionate Use of Pluristem's PLX Cells Saves the Life of a Child After Bone Marrow Transplantation Failure