StemCell Therapy

SAN DIEGO, CA--(Marketwire -05/03/12)- Regen BioPharma (Regen), Inc. a newly-formed subsidiary of Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) (BMSN.PK - News), unveiled today its operational plan for its "Super-Incubator" stem cell company.

Month 1-2: Assembly of Team. Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization.

Month 1-4: In-licensing of Intellectual Property. The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development.

Month 3-6: Interaction with Regulatory Agencies. Regen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials.

Month 6-18: Clinical Implementation. Regen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy.

Month 18-24: Exit. It is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.

"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."

About Bio-Matrix Scientific Group, Inc.:

Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is specifically focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to lung, heart, circulatory system and other internal organs.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life.

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Bio-Matrix Subsidiary "First in Class" Approach to Stem Cell Medicine

OLDSMAR, Fla., May 3, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Cryo-Cell International, Inc. announced the appointment of Linda Kelley, Ph.D., as chief scientific officer. Dr. Kelley is responsible for overseeing Cryo-Cells state-of-the art laboratory, translational medicine initiatives and quality assurance program at its stem cell and cord blood banking facility in Oldsmar, Florida. She joins the company from the Dana Farber Cancer Institute at Harvard, where she was the director of the Connell OReilly Cell Manipulation Core Facility.

Dr. Kelley is an internationally recognized, cord blood stem cell scientist whose accomplishments have helped expand the scope of stem cell therapies from bone marrow transplantation to the treatment of heart, kidney, brain and other degenerative diseases. She was a member of the board of trustees of the Foundation for Accreditation of Cellular Therapy and chaired its Standards Committee. Dr. Kelley was one of 12 scientists selected by the Institute of Medicine of the National Academies of Science to serve on the panel that advised Congress on how to allocate $80 million in funding to optimally structure a national cord blood stem cell program.

While director of the Cell Therapy Facility at the University of Utah, she established that states first umbilical cord blood collection program that enabled families to donate their childrens cord blood to the national inventory. Dr. Kelley earned graduate and post-doctoral degrees in hematology and immunology at Vanderbilt University in Nashville, Tenn., where she also served as assistant professor in the Department of Medicine.

As a leader in our field, Cryo-Cell is delighted to have someone of Dr. Kelleys caliber directing our laboratory and translational medicine initiatives. Her expertise will ensure that we continue to exceed the industrys quality standards and maintain our tradition of offering clients the absolute best in cord blood, cord tissue, and menstrual stem cell cryopreservation services, said David Portnoy, chairman and co-CEO at Cryo-Cell. Under her guidance, Cryo-Cell will be propelled to the forefront of regenerative medicine.

Kelley replaces Julie Allickson, Ph.D., who is joining the Wake Forest Institute for Regenerative Medicine (WFIRM), where she will manage translational research. WFIRM is led by Anthony Atala, M.D., a Cryo-Cell board member and preeminent stem cell scientist.

The opportunity to work in a cutting-edge facility with a staff that is exceptionally well trained was very attractive to me, said Dr. Kelley. But equally important in my decision to join Cryo-Cell, was the commitment that co-CEOs David and Mark Portnoy have made to support the advancement of regenerative medicine through partnerships with Stanford University and private research facilities. Cryo-Cell is unique among stem cell cryopreservation firms in that regard.

About Cryo-Cell International, Inc. Cryo-Cell International, Inc. was founded in 1989. In 1992, it became the first private cord blood bank in the world to separate and store stem cells. Today, Cryo-Cell has over 240,000 clients worldwide from 87 countries. Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is compliant with Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP). It is ISO 9001:2008 certified and accredited by the American Association of Blood Banks. Cryo-Cell is a publicly traded company, OTC:QB Markets Group Symbol: CCEL. Expectant parents or healthcare professionals who wish to learn more about cord blood banking and cord blood banking prices may call 1-800-STOR-CELL (1-800-786-7235) or visit http://www.cryo-cell.com/.

Forward-Looking Statement Statements wherein the terms "believes", "intends", "projects", "anticipates", "expects", and similar expressions as used are intended to reflect "forward-looking statements" of the Company. The information contained herein is subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements or paragraphs, many of which are outside the control of the Company. These uncertainties and other factors include the success of the Company's global expansion initiatives and product diversification, the Company's actual future ownership stake in future therapies emerging from its collaborative research partnerships, the success related to its IP portfolio, the Company's future competitive position in stem cell innovation, future success of its core business and the competitive impact of public cord blood banking on the Company's business, the Company's ability to minimize future costs to the Company related to R&D initiatives and collaborations and the success of such initiatives and collaborations, the success and enforceability of the Company's menstrual stem cell technology license agreements and umbilical cord blood license agreements and their ability to provide the Company with royalty fees, the ability of the reproductive tissue storage to generate new revenues for the Company and those risks and uncertainties contained in risk factors described in documents the Company files from time to time with the Securities and Exchange Commission, including the most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K filed by the Company. The Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements.

Contact: David Portnoy Cryo-Cell International, Inc. 813-749-2100 dportnoy(at)cryo-cell(dot)com

This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit http://www.prweb.com/releases/2012/5/prweb9469228.htm

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Cryo-Cell International Taps Leader in Stem Cell Therapy to Serve as Chief Scientific Officer

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Massachusetts Eye and Ear (Mass. Eye and Ear) has received institutional review board (IRB) approval to be a site for the companys Phase I/II clinical trial for dry age-related macular degeneration (dry AMD), using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

We are delighted to announce that Mass. Eye and Ear will participate as a site for our clinical trial for dry AMD, said Gary Rabin, ACTs chairman and CEO. Dr. Dean Eliott and his team are deeply committed to finding new treatments for preventing blindness, and we very much look forward to tapping into his expertise and insight into the progression of macular degenerative disorders. The primary teaching hospital for ophthalmology at Harvard Medical School, Mass. Eye and Ear is ranked as among the top ophthalmology hospitals in the country by U.S. News & World Report and has a reputation that is unrivaled.

The Phase I/II trial is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format.

Dry AMD represents one of the largest unmet medical needs in ophthalmology, commented Dr. Dean Eliott, M.D. a full time retina surgeon, scientist and Associate Director of the Retina Service at Mass. Eye and Ear. We appreciate the opportunity to get some first-hand experience with the protocol and be involved with the international team that has been assembled around the U.S. and European trials.

Founded in 1824, the Massachusetts Eye and Ear Infirmary is an independent specialty hospital affiliated with Harvard Medical School.

Further information about patient eligibility for the dry AMD study is available at http://www.clinicaltrials.gov; ClinicalTrials.gov Identifier: NCT01344993.

About dry AMD Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. Age-related macular degeneration (AMD) is the leading cause of blindness in people over age 60 in the United States, and the vast majority of cases of AMD are of the dry form, which is currently untreatable.

About hESC-derived RPE Cells The retinal pigment epithelium (RPE) is a highly specialized tissue located between the choroid and the neural retina. RPE cells support, protect and provide nutrition for the light-sensitive photoreceptors. Human embryonic stem cells differentiate into any cell type, including RPE cells, and have a similar expression of RPE-specific genes compared to human RPE cells and demonstrate the full transition from the hESC state.

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 Announces Massachusetts Eye and Ear as Additional Site for Clinical Trial for Dry Age-Related Macular Degeneration ...

PHILADELPHIA HIV patients treated with genetically modified T cells remain healthy up to 11 years after initial therapy, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the new issue of Science Translational Medicine. The results provide a framework for the use of this type of gene therapy as a powerful weapon in the treatment of HIV, cancer, and a wide variety of other diseases.

"We have 43 patients and they are all healthy," says senior author Carl June, MD, a professor of Pathology and Laboratory Medicine at Penn Medicine. "And out of those, 41 patients show long term persistence of the modified T cells in their bodies."

Early gene therapy studies raised concern that gene transfer to cells via retroviruses might lead to leukemia in a substantial proportion of patients, due to mutations that may arise in genes when new DNA is inserted. The new long-term data, however, allay that concern in T cells, further buoying the hope generated by work June's team published in 2011 showing the eradication of tumors in patients with chronic lymphocytic leukemia using a similar strategy.

"If you have a safe way to modify cells in patients with HIV, you can potentially develop curative approaches," June says. "Patients now have to take medicine for their whole lives to keep their virus under control, but there are a number of gene therapy approaches that might be curative." A lifetime of anti-HIV drug therapy, by contrast, is expensive and can be accompanied by significant side effects.

They also note that the approach the Penn Medicine team studied may allow patients with cancers and other diseases to avoid the complications and mortality risks associated with more conventional treatments, since patients treated with the modified T cells did not require drugs to weaken their own immune systems in order for the modified cells to proliferate in their bodies after infusion, as is customary for cancer patients who receive stem cell transplants.

To demonstrate the long-term safety of genetically modified T cells, June and colleagues have followed HIV-positive patients who enrolled in three trials between 1998 and 2002. Each patient received one or more infusions of their own T cells that had been genetically modified in the laboratory using a retroviral vector. The vector encoded a chimeric antigen receptor that recognizes the HIV envelope protein and directs the modified T cell to kill any HIV-infected cells it encounters.

As is standard for any trial, the researchers carefully monitored patients for any serious adverse events immediately after infusion -- none of which were seen. Additionally, because of the earlier concerns about long-term side effects, the U.S. Food and Drug Administration also asked the team to follow the patients for up to 15 years to ensure that the modified T cells were not causing blood cancers or other late effects. Therefore, each patient underwent an exam and provided blood samples during each of the subsequent years.

Now, with more than 500 years of combined patient safety data, June and colleagues are confident that the retroviral vector system is safe for modifying T cells. By contrast, June notes, the earlier, worrying side effects were seen when viral vectors were used to modify blood stem cells. The new results show that the target cell for gene modification plays an important role in long-term safety for patients treated. "T cells appear to be a safe haven for gene modification," June says.

The multi-year blood samples also show that the gene-modified T cell population persists in the patients' blood for more than a decade. In fact, models suggest that more than half of the T cells or their progeny are still alive 16 years after infusion, which means one treatment might be able to kill off HIV-infected cells for decades. The prolonged safety data means that it might be possible to test T cell-based gene therapy for the treatment of non-life threatening diseases, like arthritis.

"Until now, we've focused on cancer and HIV-infection, but these data provide a rationale for starting to focus on other disease types," June says. "What we have demonstrated in this study and recent studies is that gene transfer to T cells can endow these cells with enhanced and novel functions. We view this as a personalized medicine platform to target disease using a patient's own cells."

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Genetically Modified T Cell Therapy Shown to be Safe, Lasting in Decade-Long Penn Medicine Study of HIV Patients

SAN DIEGO, CA--(Marketwire -05/03/12)- Regen BioPharma (Regen), Inc. a newly-formed subsidiary of Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) (BMSN.PK - News), unveiled today its operational plan for its "Super-Incubator" stem cell company.

Month 1-2: Assembly of Team. Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization.

Month 1-4: In-licensing of Intellectual Property. The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development.

Month 3-6: Interaction with Regulatory Agencies. Regen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials.

Month 6-18: Clinical Implementation. Regen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy.

Month 18-24: Exit. It is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.

"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."

About Bio-Matrix Scientific Group, Inc.:

Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) is a biotechnology company focused on the development of regenerative medicine therapies and tools. The Company is specifically focused on human therapies that address unmet medical needs. Specifically, Bio-Matrix Scientific Group Inc. is looking to increase the quality of life through therapies involving stem cell treatments. These treatments are focused in areas relating to lung, heart, circulatory system and other internal organs.

Through Its wholly owned subsidiary, Regen BioPharma, it is the Company's goal to develop translational medicine platforms for the rapid commercialization of stem cell therapies. The Company is looking to use these translational medicine platforms to advance intellectual property licensed from entities, institutions and universities that show promise towards fulfilling the Company's goal of increased quality of life.

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Bio-Matrix Subsidiary "First in Class" Approach to Stem Cell Medicine

"See The Potential" program sponsored by Canada's Stem Cell Network and Pfizer

MONTRAL, May 2, 2012 /CNW/ - The first two postdoctoral research fellowships of a new program to promote stem cell research in Canada were announced today by the program's sponsors, Canada's Stem Cell Network and Pfizer.

"See The Potential" is a program established to encourage the work of promising young scientists in the field of stem cell and regenerative medicine research. Under the program, six postdoctoral fellowships will be funded from competitions over the next three years. Fellows will receive a grant of $50,000 per year for up to three years and will conduct two years of stem cell and regenerative medicine research at a recognized research laboratory in Canada as well as another year of research at the Pfizer Neusentis laboratories in the United Kingdom.

The 2011 fellowship recipients that have just been announced, following an internationally publicized competition, are Dr. Corinne Hoesli from Laval University in Qubec City and Dr. Reaz Vawda from University Health Network in Toronto. Dr. Hoesli proposes to conduct research related to engineering artificial blood vessels and is speaking today at the Till and McCulloch Meetings in Montral about the program and her research strategies. The research specialty of Dr. Vawda is comparative investigations on the therapeutic repair function of mesenchymal stem cells in the treatment of spinal cord injury.

"We are very pleased to name these first recipients of the See The Potential postdoctoral fellowships in partnership with Pfizer Inc," said Dr. Verna Skanes, Chair of the Board of the Stem Cell Network. "This program is an exciting way to provide young researchers with the opportunity to develop their research efforts and their careers while building important collaborations for the future with other researchers connected to the Stem Cell Network and, internationally, through Pfizer network. This is exactly the type of collaboration with industry that is the hallmark of translational research and one that can provide benefits to all involved."

Half the program is funded by the Stem Cell Network and other half shared by Pfizer.

"This is an excellent initiative aligned with the Pfizer Neusentis' mission to develop innovative cell therapies to benefit patients through research and development, clinical and business innovation," said academic liaison, Dr. Tim Allsopp, Head of External Research for the Regenerative Medicine activities at Pfizer Neusentis Ltd. "We congratulate our winners and look forward to witnessing the results of their important research."

The second See The Potential fellowship competition is now open with an application deadline set for June 26, 2012. For more information on the competition please visit http://www.seethepotential.ca

Canada's Stem Cell Network The Stem Cell Network, established in 2001, brings together more than 100 leading scientists, clinicians, engineers, and ethicists from universities and hospitals across Canada. The Network supports cutting-edge projects that translate research discoveries into new and better treatments for millions of patients in Canada and around the world. Hosted by the University of Ottawa, the Stem Cell Network is one of Canada's Networks of Centres of Excellence funded through Industry Canada and its three granting councils. http://www.stemcellnetwork.ca

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First fellowships awarded in new Canadian stem cell and regenerative medicine research program

01-05-2012 12:12 This video, is a testimonial of a patient from Uruguay that went to Progencell, to get treatment Juvenile Parkinson's . Talks about his experience, the procedure, the outcome and some suggestions. Language spanish with English subtitles, 7:10 min duration aprox.

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Juvenile Parkinson's - Stem cell therapy - Video

When Tyler was born, the umbilical cord was wrapped around his neck, causing a lack of oxygen to his brain that led to Tyler suffering a stroke during delivery. The stroke caused damage to the back of Tylers brain. Tyler was diagnosed with cerebral palsy and his mother, Lisa Biermann, was told to expect the worst: a child who would never walk, talk, or have any chance at a normal life.

Lisa refused to give up hope. She tried everything she could to help Tyler. Tyler could not walk because his feet would not sit flat on the floor. She tried botox injections every three months, braces, casts and even ankle cord surgery. Nothing worked.

Lisa said Tyler could not communicate with her at all. She never knew when he was in pain because he was unable to tell her.

Tyler was considered to be blind, with a prescription that was over nine units nearsighted, and his eyes jumped around. Even with glasses, he could not focus his vision, and doctors did not believe he could see, or ever would see.

Until he was 8 years old, Lisa would carry Tyler from his classes at Woodland Park Elementary.

When Tyler was 8, he had a seizure. Dr. David Steenblock, who is based in California, heard about Tyler and offered to help him with umbilical cord stem cell therapy. Lisa said she thought hard about it, and because she had tried everything else and nothing had worked, she decided to try the stem cell therapy, which Dr. Steenblock told her had no side effects.

In December 2007, Lisa, Dr. Steenblock and his team took Tyler for the treatment, which had to be done in Tijuana, Mexico, because stem cells injection is currently not legal in the United States. Three months later, they went for a second injection.

The stem cells were given to Tyler intravenously for a period of approximately 45 minutes.

Lisa said within weeks, she saw monumental changes in Tyler. All the milestones he never reached as a baby, he began reaching.

Within three months Tyler could put his feet flat on the floor and could walk independently. At six months post-treatment, he no longer needed the painful braces that gave him bunions.

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Stem cell therapy for WCMS student has remarkable results

Public release date: 2-May-2012 [ | E-mail | Share ]

Contact: Holly Auer holly.auer@uphs.upenn.edu 215-200-2313 University of Pennsylvania School of Medicine

PHILADELPHIA -- HIV patients treated with genetically modified T cells remain healthy up to 11 years after initial therapy, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the new issue of Science Translational Medicine. The results provide a framework for the use of this type of gene therapy as a powerful weapon in the treatment of HIV, cancer, and a wide variety of other diseases.

"We have 43 patients and they are all healthy," says senior author Carl June, MD, a professor of Pathology and Laboratory Medicine at Penn Medicine. "And out of those, 41 patients show long term persistence of the modified T cells in their bodies."

Early gene therapy studies raised concern that gene transfer to cells via retroviruses might lead to leukemia in a substantial proportion of patients, due to mutations that may arise in genes when new DNA is inserted. The new long-term data, however, allay that concern in T cells, further buoying the hope generated by work June's team published in 2011 showing the eradication of tumors in patients with chronic lymphocytic leukemia using a similar strategy.

"If you have a safe way to modify cells in patients with HIV, you can potentially develop curative approaches," June says. "Patients now have to take medicine for their whole lives to keep their virus under control, but there are a number of gene therapy approaches that might be curative." A lifetime of anti-HIV drug therapy, by contrast, is expensive and can be accompanied by significant side effects.

They also note that the approach the Penn Medicine team studied may allow patients with cancers and other diseases to avoid the complications and mortality risks associated with more conventional treatments, since patients treated with the modified T cells did not require drugs to weaken their own immune systems in order for the modified cells to proliferate in their bodies after infusion, as is customary for cancer patients who receive stem cell transplants.

To demonstrate the long-term safety of genetically modified T cells, June and colleagues have followed HIV-positive patients who enrolled in three trials between 1998 and 2002. Each patient received one or more infusions of their own T cells that had been genetically modified in the laboratory using a retroviral vector. The vector encoded a chimeric antigen receptor that recognizes the HIV envelope protein and directs the modified T cell to kill any HIV-infected cells it encounters.

As is standard for any trial, the researchers carefully monitored patients for any serious adverse events immediately after infusion -- none of which were seen. Additionally, because of the earlier concerns about long-term side effects, the U.S. Food and Drug Administration also asked the team to follow the patients for up to 15 years to ensure that the modified T cells were not causing blood cancers or other late effects. Therefore, each patient underwent an exam and provided blood samples during each of the subsequent years.

Now, with more than 500 years of combined patient safety data, June and colleagues are confident that the retroviral vector system is safe for modifying T cells. By contrast, June notes, the earlier, worrying side effects were seen when viral vectors were used to modify blood stem cells. The new results show that the target cell for gene modification plays an important role in long-term safety for patients treated. "T cells appear to be a safe haven for gene modification," June says.

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Genetically modified T cell therapy shown to be safe, lasting in decade-long study of HIV patients

Public release date: 1-May-2012 [ | E-mail | Share ]

Contact: Charles Casey charles.casey@ucdmc.ucdavis.edu 916-734-9048 University of California - Davis Health System

UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.

In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.

"We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system."

To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.

Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:

a human/rhesus macaque TRIM5 isoform, which disrupts HIV from uncoating in the cytoplasm a CCR5 short hairpin RNA (shRNA), which prevents certain strains of HIV from attaching to target cells a TAR decoy, which stops HIV genes from being expressed inside of the cell by soaking up a critical protein needed for HIV gene expression These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.

The results were successful on all counts.

"After we challenged transplanted mice with live HIV, we demonstrated that the cells with HIV-resistant genes were protected from infection and survived in the face of a viral challenge, maintaining normal human CD4 levels," said Anderson. CD4+ T-cells are a type of specialized immune cell that HIV attacks and uses to make more copies of HIV.

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Study using stem cell therapy shows promise in fight against HIV

ScienceDaily (May 2, 2012) UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS.

In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load.

"We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system."

To establish immunity in mice whose immune systems paralleled those of patients with HIV, Anderson and his team genetically modified human blood stem cells, which are responsible for producing the various types of immune cells in the body.

Building on work that members of the team have pursued over the last decade, they developed several anti-HIV genes that were inserted into blood stem cells using standard gene-therapy techniques and viral vectors (viruses that efficiently insert the genes they carry into host cells). The resulting combination vector contained:

These engineered blood stem cells, which could be differentiated into normal and functional human immune cells, were introduced into the mice. The goal was to validate whether this experimental treatment would result in an immune system that remained functional, even in the face of an HIV infection, and would halt or slow the progression toward AIDS.

The results were successful on all counts.

"After we challenged transplanted mice with live HIV, we demonstrated that the cells with HIV-resistant genes were protected from infection and survived in the face of a viral challenge, maintaining normal human CD4 levels," said Anderson. CD4+ T-cells are a type of specialized immune cell that HIV attacks and uses to make more copies of HIV.

"We actually saw an expansion of resistant cells after the viral challenge, because other cells which were not resistant were being killed off, and only the resistant cells remained, which took over the immune system and maintained normal CD4 levels," added Anderson.

The data provided from the study confirm the safety and efficacy of this combination anti-HIV lentiviral vector in a hematopoietic stem cell gene therapy setting for HIV and validated its potential application in future human clinical trials. The team has submitted a grant application for human clinical trials and is currently seeking regulatory approval, which is necessary to move on to clinical trials.

Continued here:
Stem cell therapy shows promise in fight against HIV

South San Francisco, CA (Marketwire) - VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, has secured a new United States patent covering the company's proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, (U.S. Patent 11/445,733), titled "Toxicity Typing Using Liver Stem Cells," cover all mammalian liver stem cells -- rat and mouse cells, for example, in addition to human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS).

H. Ralph Snodgrass, Ph.D., VistaGen's President and Chief Scientific Officer, said, "This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. The specific sets of genes that are affected become a profile of that drug."

VistaGen's new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity. Using sophisticated "pattern matching" database tools, drug developers can analyze these related profiles to determine "gene expression signatures" that are common and predictive of drugs that produce specific types of toxicity.

"Without this database capability, a drug's single gene expression profile could not be interpreted," Dr. Snodgrass added. "The ability to use liver stem cells to differentiate drug-dependent gene expression profiles, and to compare those profiles of drugs known to induce toxic liver effects, provides a powerful tool for predicting liver toxicity of new drug candidates, including drug rescue variants."

Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube platform. This new liver toxicity typing patent further solidifies our growing IP portfolio, and supports the continuing development of LiverSafe 3D, our human liver cell-based bioassay system, which complements our CardioSafe 3D human heart cell-based bioassay system for heart toxicity."

About VistaGen Therapeutics VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart toxicity after substantial development by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101. Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward Looking Statements The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals, the issuance and protection of patents and other intellectual property, the success of VistaGen's ongoing clinical studies, including the safety and efficacy of its drug candidate, AV-101, the failure of future drug rescue and pilot preclinical cell therapy programs related to VistaGen's stem cell technology-based Human Clinical Trial in a Test Tube platform, its ability to enter into drug rescue collaborations, risks and uncertainties relating to the availability of substantial additional capital to support VistaGen's research, development and commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to AV-101 and any drug rescue variants identified and developed by VistaGen. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

SOURCE: VistaGen Therapeutics, Inc.

More:
VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used To Test Drug Candidates For Liver Toxicity

MONTREAL, QUEBEC--(Marketwire -04/30/12)- With a shared goal of supporting development projects that will boost innovation in the growing field of stem cells and biomaterials-based products, Pfizer Canada and the Centre for Commercialization of Regenerative Medicine (CCRM) have established the Pfizer-CCRM Innovation Fund to accelerate regenerative medicine (RM) technologies for drug screening and therapeutic applications. The announcement is being made at the first annual Till & McCulloch Meetings (April 30-May 2), Canada's premier stem cell meeting, jointly hosted by the Stem Cell Network and CCRM.

"CCRM was created on the premise that it would work with academia and industry on projects that will hopefully move RM technologies and innovations from the bench to the bedside," says Michael May, CEO of CCRM. "Canada is already a leader in this field and additional funding to advance novel research through early product development will only make us stronger. We're very pleased to be partnering with Pfizer Canada and appreciate their confidence in joining with us."

"Pfizer Canada is pleased to contribute to this new fund which will support important research here in Canada," explains Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada. "With the novel resources offered through CCRM's development capabilities, we hope to help advance the RM field in this country."

Pfizer Canada has contributed a total of $500,000 to the Pfizer-CCRM Innovation Fund and CCRM will contribute matching dollars to any approved projects undertaken in the duration of this fund.

About Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading biopharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc. invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas. Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. For more information, visit http://www.pfizer.ca

Here is the original post:
New Fund Established to Stimulate Regenerative Medicine Industry

--Study lends support to safe use for therapy

Newswise A team of researchers from Johns Hopkins University and the National Human Genome Research Institute has evaluated the whole genomic sequence of stem cells derived from human bone marrow cellsso-called induced pluripotent stem (iPS) cellsand found that relatively few genetic changes occur during stem cell conversion by an improved method. The findings, reported in the March issue of Cell Stem Cell, the official journal of the International Society for Stem Cell Research (ISSCR), will be presented at the annual ISSCR meeting in June.

Our results show that human iPS cells accrue genetic changes at about the same rate as any replicating cells, which we dont feel is a cause for concern, says Linzhao Cheng, Ph.D., a professor of medicine and oncology, and a member of the Johns Hopkins Institute for Cell Engineering.

Each time a cell divides, it has the chance to make errors and incorporate new genetic changes in its DNA, Cheng explains. Some genetic changes can be harmless, but others can lead to changes in cell behavior that may lead to disease and, in the worst case, to cancer.

In the new study, the researchers showed that iPS cells derived from adult bone marrow cells contain random genetic changes that do not specifically predispose the cells to form cancer.

Little research was done previously to determine the number of DNA changes in stem cells, but because whole genome sequencing is getting faster and cheaper, we can now more easily assess the genetic stability of these cells derived by various methods and from different tissues, Cheng says. Last year, a study published in Nature suggested higher than expected cancer gene mutation rates in iPS cells created from skin samples, which, according to Cheng, raised great concerns to many in the field pertaining to usefulness and safety of the cells. This study analyzed both viral and the improved, nonviral methods to turn on stem cell genes making the iPS cells

To more thoroughly evaluate the number of genetic changes in iPS cells created by the improved, non-viral method, Chengs team first converted human blood-forming cells or their support cells, so-called marrow stromal cells (MSCs) in adult bone marrow into iPS cells by turning on specific genes and giving them special nutrients. The researchers isolated DNA from--and sequenced--the genome of each type of iPS cells, in comparison with the original cells from which the iPS cells were derived.

Cheng says they then counted the number of small DNA differences in each cell line compared to the original bone marrow cells. A range of 1,000 to 1,800 changes in the nucleic acid letters A, C, T and G occurred across each genome, but only a few changes were found in actual genes--DNA sequences that act as blueprints for our bodys proteins. Such genes make up two percent of the genome.

The blood-derived iPS cells contained six and the MSC-derived iPS cells contained 12 DNA letter changes in genes, which led the researchers to conclude that DNA changes in iPS cells are far more likely to occur in the spaces between genes, not in the genes themselves.

Next, the investigators examined the severity of the DNA changes--how likely each one would disrupt the function of each gene. They found that about half of the DNA changes were silent, meaning these altered blueprints wouldnt change the nucleic acid building code for its corresponding protein or change its function.

Link:
Improved Adult-Derived Human Stem Cells Have Fewer Genetic Changes Than Expected

SOURCE: American CryoStem Corporation

RED BANK, NJ--(Marketwire - Apr 30, 2012) - American CryoStem Corporation (OTCQB: CRYO) announced the launch of its new adipose tissue and adult stem cell testing services to assist physicians involved in tissue engraftment, regenerative medicine procedures and cellular therapies utilizing adult adipose derived stem cells. The new testing services provide physicians an affordable method for self assessment of their procedures and methods to better understand the relationship between tissue quality and engraftment success.

American CryoStem recognizes the need for independent testing services as reinforced by the increasing focus and scrutiny of physician office based tissue laboratories by the US Food and Drug Administration (FDA). The menu of testing services includes full 14 day sterility testing, viability testing, growth assay and additional tests for each selected service. The tests can be ordered individually or in multiples over time and are designed to allow physicians to self evaluate their current methods and performance, or to assess new methods or devices designed to improve procedure and tissue quality. Long term and customized programs are available upon request. Physicians enrolled as a provider of the Company's stem cell storage services can obtain discounts for individual and multi test programs.

"We are very excited about rolling these new services out to our existing providers and all participants in the tissue engraftment, regenerative medicine and cellular therapy markets. We believe that this is the first such program offered commercially and meets a critical need for the advancement of the regenerative and cellular therapy markets," said Anthony Dudzinski, the Company's COO. "Now there is a way for physicians to assess their own performance without the need to overcome the significant costs of purchasing and maintaining their own testing facilities."

The new testing services are offered by ACS Laboratories reflects the Company's increasing branding and commercialization of products and services developed around its proprietary clinical tissue processing and storage methodologies. ACS Laboratory incorporates its proprietary cGMP/cGTP aseptic methods and FDA guidance's into these services to ensure the highest quality and most useful information for physicians.

About American CryoStem: American CryoStem Corporation (OTCQB: CRYO) markets clinical processing services and patented products for Adipose (fat) Tissue and Adipose Derived Adult Stem Cells. The Company's clinical processing, patented cell culture media products and cellular preservation platform supports the science and regenerative medicine applications being developed globally. The Company provides the highest quality, clinically processed cells assuring their purity, viability and growth capabilities, while at the same time developing cutting edge applications, therapies and patented laboratory products and services for consumer and commercial applications.

Link:
American CryoStem Announces ACS Laboratories Adipose Tissue and Adult Stem Cell Testing Services

NES ZIONA, Israel--(BUSINESS WIRE)--

Kadimastem, an Israeli Biotechnology company that develops human pluripotent stem cell-related products, today announced the signing of a five year framework agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany. The agreement concerns the use of Kadimastem's drug-screening platform to discover new oral drugs for the treatment of the neurological disease Multiple Sclerosis (MS).

The system developed by Kadimastem allows using human functional tissues produced industrially from pluripotent stem cells as a means to search for potential new drugs, a direct approach that has advantages over the use of animals. In Multiple Sclerosis, the insulating myelin sheaths which cover many nerves in the brain and spinal cord are destroyed due to loss of the myelin-forming cells resulting in the impairment of nerve function and severe neurological disabilities. It is estimated that 2.5 million patients suffer from this disease around the globe. While the existing treatments act by slowing down the loss of myelin-forming cells, there is great interest in finding new medications that could repair the myelin by stimulating the regeneration of myelin-forming cells. The drug-screening project, to be carried out through the Kadimastem-Merck Serono agreement, aims precisely at the discovery of potential oral drugs that act by stimulating myelin repair.

We are pleased to announce this agreement with Merck-Serono, a company with robust experience in drug discovery, development and marketing in the Multiple Sclerosis area, said Mr. Yossi Ben-Yossef, CEO of Kadimastem. The undisclosed compensation for this agreement will provide financial support for Kadimastem's own in-house drug discovery initiatives, in the field of neurodegenerative diseases as well as in the field of Diabetes. Kadimastem also produces pancreatic islet cells from pluripotent stem cells, for screening of drugs enhancing insulin secretion and eventually for cellular therapy of Diabetes.

Prof. Michel Revel, Chief Scientist of Kadimastem, further commented: We are very proud that after a thorough evaluation, Merck Serono decided to sign an agreement with us. We see it as a proof of our excellence in developing human myelin-forming cells and our capabilities in drug screening. We believe that this agreement is a first step towards further collaboration with Merck Serono and other Pharmaceutical companies, in which our capabilities in drug screening on human functional cell systems will synergize with their capabilities in medicinal chemistry and clinical development, to make drugs available more rapidly and more efficiently.

Prof. Revel from the Weizmann Institute of Science was the Chief Scientist of InterPharm, an Israeli biotech company part of the Merck Serono group that developed Prof. Revel's groundbreaking research which lead to Rebif (mammalian cell-produced recombinant Interferon beta-1a), today a leading drug for the treatment of Multiple Sclerosis with annual sales by Merck Serono of over US$ 2.3 billion.

Mr. Amir Naiberg, CEO of Yeda, the commercial arm of the Weizmann Institiute of Science, said: We are excited that Kadimastem, that was established around one of our technologies, is collaborating with Merck Serono. Merck Serono has a long and successful tradition of developing products that emerged from the Weizmann Institute labs,and we hope that Kadimastem will be another link in this chain.

About Kadimastem

Kadimastem (www.kadimastem.com) is a biotechnology company focused on the industrial development and commercialization of human pluripotent stem cell-based products. At Kadimastem, the pluripotent stem cell technology is used to produce specialized human cells and tissues for two major types of medical applications: 1) Drug-screening platforms using human functional cells and tissues as in vitro assays for discovering novel therapeutic drugs for neurological diseases and diabetes, and 2) Cell therapy for regenerative medicine, to repair tissues and organs affected by diseases, such as implanting insulin-secreting pancreatic islet cells as a treatment for insulin-dependent diabetes. Kadimastem is developing these technologies in its state of the art 1,000 m2 facilities in the Weizmann Science Park (Ness Ziona, Israel), for industrial research and production, with a staff of PhD-level and MSc-level scientists. Kadimastem uses pluripotent human stem cells made available through licensing agreements with the Embryonic Stem Cell Center of the Hadassah Medical center in Jerusalem (Prof. Benjamin Reubinoff) and the Shaarei Zedek Medical Center, Jerusalem, Israel.

About Merck Serono

Link:
Pharmaceutical Company Merck Serono Signs an Agreement to Use Kadimastem's Platform for Drug Screening

Eliminating smoking at home reduces the risk of sudden infant death syndrome (SIDS) by 80 percent, an Australian study has found.

Research from the University of Sydney has proven a link between noxious fumes and SIDS. It found nicotine, the main neurotoxin found in cigarette smoke, increased the risk of SIDS by damaging brain stem cells receptive to the drug.

The results, published in the journal of Toxicology and Applied Pharmacology, followed up on the research team's previous 2007 study of babies who died of SIDS that proved any smoke exposure contributed to brain cell death.

Of the 67 babies who died of SIDS in the research group, 81 percent were exposed to cigarette smoke.

International studies have shown the babies of mothers who smoke during pregnancy have a five-fold increase in the risk of SIDS, while babies born into a home where there is a smoker have a three-fold risk.

"We found any smoke exposure in the home resulted in a greater number of cells dying in the brain stem which controls heart rate, respiration and sleep and arousal," researcher Dr. Rita Machaalani said.

The incidence of SIDS has decreased by 85 percent in the past 25 years due to safe sleep education programs that recommend babies be placed on their backs to sleep.

Almost one in five women still smoke in pregnancy, including 42 percent of teenagers and 52 percent of indigenous women.

"The most outstanding risk factor is tobacco smoke and it's one of the hardest ones to shake," Ros Richardson, from SIDS and Kids NSW, said.

"Smoking in pregnancy is also associated with a higher risk of stillbirth and pre-term birth and neonatal loss."

See the original post here:
Study finds smoking leads to increase in sudden infant death syndrome

When Tyler was born, the umbilical cord was wrapped around his neck, causing a lack of oxygen to his brain that led to Tyler suffering a stroke during delivery. The stroke caused damage to the back of Tylers brain. Tyler was diagnosed with cerebral palsy and his mother, Lisa Biermann, was told to expect the worst: a child who would never walk, talk, or have any chance at a normal life.

Lisa refused to give up hope. She tried everything she could to help Tyler. Tyler could not walk because his feet would not sit flat on the floor. She tried botox injections every three months, braces, casts and even ankle cord surgery. Nothing worked.

Lisa said Tyler could not communicate with her at all. She never knew when he was in pain because he was unable to tell her.

Tyler was considered to be blind, with a prescription that was over nine units nearsighted, and his eyes jumped around. Even with glasses, he could not focus his vision, and doctors did not believe he could see, or ever would see.

Until he was 8 years old, Lisa would carry Tyler from his classes at Woodland Park Elementary.

When Tyler was 8, he had a seizure. Dr. David Steenblock, who is based in California, heard about Tyler and offered to help him with umbilical cord stem cell therapy. Lisa said she thought hard about it, and because she had tried everything else and nothing had worked, she decided to try the stem cell therapy, which Dr. Steenblock told her had no side effects.

In December 2007, Lisa, Dr. Steenblock and his team took Tyler for the treatment, which had to be done in Tijuana, Mexico, because stem cells injection is currently not legal in the United States. Three months later, they went for a second injection.

The stem cells were given to Tyler intravenously for a period of approximately 45 minutes.

Lisa said within weeks, she saw monumental changes in Tyler. All the milestones he never reached as a baby, he began reaching.

Within three months Tyler could put his feet flat on the floor and could walk independently. At six months post-treatment, he no longer needed the painful braces that gave him bunions.

See the original post:
Stem cell therapy for WCMS student has remarkable results

Source:
http://feeds.feedburner.com/integratedmedicine

The $3 billion California stem cell agency, which is moving to engage the biotech industry ever more closely, is proposing a major weakening of the financial disclosure requirements for its board of directors and executives.

The move comes as the agency is also seeking to raise cash from the private sector to continue the state research effort's existence.  CIRM's dimming of transparency runs counter to government trends nationally for more disclosure rather than less, including regulations enacted last year by the NIH.

The proposed changes will be considered next Thursday by the CIRM directors' Governance Subcommittee, which will have public teleconference sites in San Francisco and Irvine and two each in Los Angeles and La Jolla.

Currently CIRM board members and top executives must disclose all their investments and income – in a general way – along with California real property that they hold. Under the changes, disclosures would instead be required only "if the business entity or source of income is of the type to receive grants or other monies from or through the California Institute for Regenerative Medicine." CIRM offered no explanation of what it means by "of the type to receive" funds from the agency.

The proposal further narrows disclosure in connection with income or investments in enterprises that provide facilities or services used by CIRM. With the removal of the requirement for reporting all investments, CIRM's changes also specified disclosure of income and investments connected to business entities (nonprofits are not mentioned) that are engaged in biomedical research or the manufacture of biomedical pharmaceuticals.

The new code would appear to give CIRM directors and executives wide personal latitude in determining what should be disclosed. The current language simply states that "all" investments, etc., must be disclosed. That language originated in the 1974 ballot initiative that created the state disclosure requirements. The initiative's intent was to give the public and interested parties access to key information that would allow them to determine what forces are at work in government and whether conflicts of interests exist – as opposed to simply trusting the assertions of officials without additional substantiation.

The new code also appears to relieve CIRM officials of reporting investment in or income from venture capital or other firms that may be engaged in financing biotech or stem cell enterprises, since the firms do not receive cash from CIRM or engage in biomedical research.

While the code appears to provide more reporting freedom for board members and executives, it also may indirectly impose a burden on them to determine whether any of their investments may involve biomedical research or enterprises that could possibly receive funds from CIRM at some point

Earlier this week, the California Stem Cell Report asked the stem cell agency about such issues. Kevin McCormack, CIRM's new senior director of public communications and patient advocate outreach, replied that the changes were "proposed" by the state Fair Political Practices Commission, which oversees state disclosure laws.

He said the FPPC says agencies "should tailor their disclosure categories to type of work performed by the agency."

McCormack cited as examples the State Board of Education and the state retirement system.

As for the specific changes in CIRM's code, McCormack said,

"Because these are the types of entities that are likely to create potential conflicts of interest, we believe the disclosure categories are appropriate."

McCormack did not comment on whether the proposed code would give board members more reporting latitude or whether it relieve them of reporting investments tied to the financing of biotech or stem cell firms. (The text of his response can be found here.)

The California Stem Cell Report is querying the FPPC concerning its policy regarding disclosure codes. CIRM's new code is expected to go before the the full CIRM board in late May. The changes are subject to review by the FPPC and then must formally go through the state administrative law process during which the public can comment and the code modified before final adoption.

Our take? The proposed changes are not in the best interests of CIRM or the people of California. The absence of transparency and disclosure only breeds suspicious speculation of the worst sort. The agency is already burdened by conflicts of interest that are built in by the ballot measure that created it in 2004. Nearly all of the $1.3 billion that CIRM has handed out has gone to institutions linked to CIRM directors. Weakening disclosure at a time when the biotech industry will become more closely tied to CIRM inevitably raises questions about financial linkages – present and future – between CIRM directors and executives and industry. For the past seven years, CIRM directors and staff have been able to comply with
more complete disclosure. They should continue to do so for the life of the agency, which will expire in less than a decade unless it finds additional sources of cash.

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