Posted: March 14, 2014 at 10:45 pm
Sweden Medical Forum, part 13 - Ms. Kristina Runeberg, Cellectis
Ms. Kristina Runeberg, Cellectis AB "Industrial platform for scale-up and differentiation of human pluripotent stem cells for Regerative Medicine" Find addit...
By: C0Orinir
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Sweden Medical Forum, part 13 - Ms. Kristina Runeberg, Cellectis - Video
Posted: March 14, 2014 at 10:45 pm
Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.
This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:
-How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to support the approval of regenerative therapies. -FDAs regulation of some regenerative medicine products and accessories as Medical Devices. -The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products. -The labeling and marketing of regenerative products and therapies. -The potential for enforcement action and recommendations for mitigating that risk. -The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.
Learning Objectives: Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:
-How FDA regulates regenerative treatments and therapies? -The HCT/P Criteria and Minimal Manipulation Standard. -The Drug and Biological Approval Process. -Regenerative Products as Medical Devices. -How to Design Appropriate Clinical Trials? -Applicable cGMPs and cGLPs. -Marketing Exclusivity and Patent Restoration. -Product Labeling, Marketing and Advertising. -FDA and other Federal Agency Enforcement Action. -The Regulation of Veterinary Regenerative Medicine. -The New Animal Drug Application (NADA) Process. -Veterinary User Fees and Waivers.
Who will benefit: This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:
-Senior quality managers -Quality professionals -Regulatory professionals -Compliance professionals -Production supervisors -Manufacturing engineers -Production engineers -Design engineers -Labelers and Private Labelers -Contract Manufacturers -Importers and Custom Agents -U.S. Agents of Foreign Corporations -Process owners -Quality engineers -Quality auditors -Document control specialists -Record retention specialists -Medical affairs -Legal Professionals -Financial Advisors and Institutional Investors -Consultants, Inspectors and cGMP Experts
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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.
Posted: March 14, 2014 at 10:40 pm
University of Washington researchers have created a line of human embryonic stem cells with the ability to develop into a far broader range of tissues than most existing cell lines.
"These cells will allow us to gain a much greater understanding of normal embryonic development and have the real potential for use in developing ways to grow new tissues and organs for transplantation," said Carol Ware, a professor of comparative medicine. She is the lead author of a paper describing the new cell line.
The findings are reported in the March 10 issue of the journal Proceedings of the National Academy of Sciences. The cells, called nave embryonic stem cells, normally appear at the earliest stages of embryonic development. They retain the ability to turn into any of all the different types of cells of the human body -- a capacity called "pluripotency."
Researchers had been able to develop nave cells using mouse embryonic stem cells, but to create naive human embryonic stem cells has required inserting a set of genes that force the cells to behave like naive cells.
While these transgenic cells are valuable research tools, the presence of artificially introduced genes meant the cells will not develop as normal embryonic cells would nor could they be safely used to create tissues and organs for transplantation.
In an article, Ware and her colleagues from the UW Institute for Stem Cell and Regenerative Medicine describe how they successfully created a line of nave human embryonic stem cells without introducing an artificial set of genes.
They first took embryonic stem cells that are slightly more developed, called primed stem cells, and grew them in a medium that contained factors that switched them back -- or "reverse toggled" them -- to the nave state. They then used the reverse toggled cells to develop a culture medium that would keep them in the nave state and create a stable cell line for study and research.
While the "reverse toggled" cells are much easier to create and will prove valuable research tools, Ware said, the cells that were directly derived from embryos are the more important advance because they are more likely to behave, grow and develop as embryonic cells do in nature.
The new cell line is called Elf1: "El" for the Ellison Foundation, a major supporter of the lab's work; "f" for female, the sex of the stem cell; and "1" for first.
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New cell line should accelerate embryonic stem cell research
Posted: March 14, 2014 at 10:40 pm
Many clinics that are offering stem cell treatments make claims about what stem cells can and cannot do that are not supported by our understanding of science. The information on this page corrects some of the misinformation that is being widely circulated.
There are many different types of stem cells that come from different placesin the body or are formed at different times in our lives. These include embryonic stem cells that exist only at the earliest stages of development and various types of tissue-specific or adult stem cells that appear during fetal development and remain in our bodies throughout life.
Our bodies use different types of tissue-specific stem cells to fit a particular purpose. Tissue-specific stem cells are limited in their potential and largely make the cell types found in the tissue from which they are derived. For example, the blood-forming stem cells (or hematopoietic stem cells) in the bone marrow regenerate the blood, while neural stem cells in the brain make brain cells. A neural stem cell wont spontaneously make a blood cell and likewise a hematopoietic stem cell wont spontaneously make a brain cell. Thus, it is unlikely that a single cell type could be used to treat a multitude of unrelated diseases that involve different tissues or organs. Be wary of clinics that offer treatments with stem cells thatoriginate from a part of the body that is different from the part being treated.
Read more about differentTypes of Stem Cells
As described above, each type of stem cell fulfills a specific function in the body and cannot be expected to make cell types from other tissues. Thus, it is unlikely that a single type of stem cell treatment can treat multiple unrelated conditions, such as diabetes and Parkinsons disease. The underlying causes are very different and different cell types would need to be replaced to treat each condition. It is critical that the cell type used as a treatment be appropriate to the specific disease or condition.
Embryonic stem cells may one day be used to generate treatments for a range of human diseases. However, embryonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors and are unlikely to become the cells needed to regenerate a tissue on their own. They would first need to be coaxed to develop into specialized cell types before transplantation. A major warning sign that a clinic may not be credible is when treatments are offered for a wide variety of conditions but rely on a single cell type.
The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely restricted. The best defined and most extensively used is blood stem cell transplantation to treat diseases and conditions of the blood and immune system, or to restore the blood system after treatments for specific cancers. Some bone, skin and corneal diseases or injuries can be treated with grafting of tissue that depends upon stem cells from these organs. These therapies are also generally accepted as safe and effective by the medical community.
There are three main reasons why a person might feel better that are unrelated to the actual stem cell treatment: the placebo effect, accompanying treatments, and natural fluctuations of the disease or condition. The intense desire or belief that a treatment will work can cause a person to feel like it has and to even experience positive physical changes, such as improved movement or less pain. This phenomenon is called the placebo effect. Even having a positive conversation with a doctor can cause a person to feel improvement. Likewise, other techniques offered along with stem cell treatmentsuch as changes to diet, relaxation, physical therapy, medication, etc.may make a person feel better in a way that is unrelated to the stem cells. Also, the severity of symptoms of many conditions can change over time, resulting in either temporary improvement or decline, which can complicate the interpretation of the effectiveness of treatments. These factors are so widespread that without testing in a controlled clinical study, where a group that receives a treatment is carefully compared against a group that does not receive this treatment, it is very difficult to determine the real effect of any therapy. Be wary of clinics that measure or advertise their results primarily through patient testimonials.
Science, in general, is a long and involved process. Understanding what goes wrong in disease or injury and how to fix it takes time. New ideas have to be tested first in a research laboratory, and many times the new ideas dont work. Even once the basic science has been established, translating it into an effective medical treatment is a long and difficult process. Something that looks promising in cultured cells may fail as a therapy in an animal model and something that works in an animal model may fail when it is tried on humans. Once therapies are tested in humans, ensuring patient safety becomes a critical issue and this means starting with very few people until the safety and side effects are better understood.
If a treatment has not been carefully designed, well studied and gone through the necessary preclinical and clinical testing, it is unlikely to have the desired effect. Even more concerning is that it may prove to make the condition worse or have dangerous side effects. SeeHow Science Becomes Medicine
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Top 10 Stem Cell Treatment Facts | Closer Look
Posted: March 14, 2014 at 10:40 pm
St. Petersburg, Floriday (PRWEB) March 13, 2014
Dr. Jeffrey Adler of Adler Footcare New York is presenting at the 7th Annual Graham International Implant Symposium, a two-day event that brings together foot and ankle specialists to present and attend lectures on the latest in foot and ankle topics. Dr. Adler will be speaking on the use of stem cells in the first MP (metacarpophalangeal) joint surgery.
Stem Cell Replacement Therapy offers an advanced treatment option for problems like plantar fasciitis, Osteoarthritis, Achilles tendonitis and torn soft tissue.
Stem Cell Replacement Therapy is proving to be much more effective and long lasting than traditional treatments.
In the past common foot problems have been treated by physical therapy or orthotic therapy, but the results have often been poor, leaving patients continuing to struggle with the foot pain.
Stem cells are used by many physicians to treat a broad variety of conditions because of their ability to either replicate themselves or change into the cell type that is needed to repair the tissue that has been damaged. The New York podiatrists at Adler Footcare introduce live birth stem cells into the affected area. When a patient comes in for stem cell therapy, the affected area is carefully measured so the stem cells can be delivered directly to the area that needs the treatment.
Stem cell treatment helps patients heal much quicker and allows them to return to their normal activities much sooner, Dr. Adler said. Actual recovery time will depend on each individual patients general health and medical diagnosis, but in the end they will be able to live life without chronic foot pain.
Treatments using stem cells have been used by physicians for over 100 years. Stem Cell Replacement Therapy is covered by commercial insurance and Medicare, and is approved and regulated by the FDA. The product is tested and screened by medical professionals to eliminate the potential of any communicable diseases.
Graham International Implant Institute
The Graham International Implant Institute (GIII) is a global-reaching organization dedicated to research, training, certification and support on implantology for foot physicians worldwide.
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Dr. Jeffrey Adler Presents on Use of Stem Cell Therapy at Graham International Implant Symposium
Posted: March 14, 2014 at 6:44 am
Philadelphia, PA (PRWEB) March 13, 2014
Bioquark, Inc., (http://www.bioquark.com) a company focused on the development of combinatorial biologics for regeneration and disease reversion in human organs and tissues, today announces the appointment of Dr. Luis Martinez, MD, MPH, as VP of Global Operations.
We are honored to have someone with Dr. Martinezs experience join us as we execute on a globalized strategy in regenerative medicine, said Ira S. Pastor, CEO, Bioquark Inc. His broad clinical experience in applied regenerative medicine and cellular therapies make him a very valuable addition to the Bioquark team.
Dr. Martinez is a regenerative medicine and cell therapy specialist with over 10 years of experience in the clinical setting. He is currently the President of Elite Regenerative Medicine Group, a premier treatment and research center specializing in cell therapy applications for therapeutic, regenerative and preventive purposes. Dr. Martinez obtained his medical degree, as well as his Master of Public Health, at the Ponce School of Medicine and Health Sciences, and completed his residency at the prestigious University of Pennsylvania. He also completed a fellowship in biosecurity with the UPMC Center for Health Security. He is currently a clinical instructor at the Ponce School of Medicine and Health Sciences and is a board certified physician. Dr. Martinez also serves as vice-president of the XanoGene Anti-Aging Clinic and is President at Xyrion Medical, a biomedical consulting firm. He is a current consultant for multiple biomedical and pharmaceutical companies and conducts clinical research for various clients in the industry. Dr. Martinez is also a renowned international speaker, speaking at multiple venues for professional and academic organizations and he offers training to physicians in multiple applications of regenerative medicine, including Platelet Rich Plasma (PRP) therapy, adipose and bone marrow stem cell derived harvesting, preparation and therapeutic administration, as well as cytokine, growth factor and peptide therapies.
I am very excited about the biologic candidates being developed at Bioquark Inc. and their very novel approach to human regeneration and disease reversion, which has broad clinical applicability towards a range of degenerative disorders," said Dr. Martinez. "I'm pleased to be joining the team and am looking forward to playing a more active role in this truly transformational platform."
About Bioquark, Inc.
Bioquark Inc. is focused on the development of biologic based products that have the ability to alter the regulatory state of human tissues and organs, with the goal of curing a wide range of diseases, as well as effecting complex regeneration. Bioquark is developing biological pharmaceutical candidates, as well as products for the global consumer health and wellness market segments.
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Bioquark Inc. Announces the Appointment of Dr. Luis Martinez, MD, MPH, Regenerative Medicine and Cell Therapy ...
Posted: March 14, 2014 at 6:42 am
Transcript Stephen J. Russell, M.D., Ph.D. Deputy Director Regenerative Medicine Translation
Stephen J. Russell, M.D., Ph.D.: Regenerative medicine is a very broad, new approach to medicine which uses the advances in stem cell technology, primarily, to advance clinical care. And what that really converts into is that instead of treating chronic diseases with drugs that have a short-term effect, and that need to be continued long term as a consequence, we can think in terms of regenerative medicine of solutions to problems.
If you think about what kind of illnesses people get, most of them are a consequence of degeneration or aging. I mean, as you go through life things stop working properly, so, you know, your eyesight begins to fail, your hearing begins to fail, you start to get problems with your joints, your muscles become weak, your heart begins to fail, your liver, your kidneys, everything, as you get older, is more likely to stop functioning correctly. And regeneration is the exact opposite of this degenerative process. I mean, the whole idea is to try and restore organs and prevent the deterioration.
I see regenerative medicine as the new surgery. I mean if you go back over Mayo Clinic's history, we were built on the brilliance of the Mayo brothers' surgery. We're seeing some real opportunity in certain specific areas that we're focusing on at this point in time. One of those is diabetes. I mean we do know that if we transplant a pancreas or if we transplant islets, the part of the pancreas that produces insulin and senses glucose, we can cure diabetes. There simply are not enough pancreas transplants available or islets available to be able to serve the need of the population because diabetes is common. So that's where regenerative medicine comes in as a way to generate islets from other cell types, generate islets from the patient's own skin cells or whatever, and so we really see that as a major opportunity.
Though great progress has been made in medicine, current evidence-based and palliative treatments are increasingly unable to keep pace with patients' needs, especially given our aging population. There are few effective ways to treat the root causes of many diseases, injuries and congenital conditions. In many cases, clinicians can only manage patients' symptoms using medications or devices.
Regenerative medicine is a game-changing area of medicine with the potential to fully heal damaged tissues and organs, offering solutions and hope for people who have conditions that today are beyond repair.
Regenerative medicine itself isn't new the first bone marrow and solid-organ transplants were done decades ago. But advances in developmental and cell biology, immunology, and other fields have unlocked new opportunities to refine existing regenerative therapies and develop novel ones.
The Center for Regenerative Medicine takes three interrelated approaches:
Rejuvenation. Rejuvenation means boosting the body's natural ability to heal itself. Though after a cut your skin heals within a few days, other organs don't repair themselves as readily.
But cells in the body once thought to be no longer able to divide (terminally differentiated) including the highly specialized cells constituting the heart, lungs and nerves have been shown to be able to remodel and possess some ability to self-heal. Teams within the center are studying how to enhance self-healing processes.
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About Regenerative Medicine - Mayo Clinic Research
Posted: March 13, 2014 at 8:41 pm
Stem Cell Research- Olivia Bishop
Stem Cell Research Speech Darnell COM 201- 12.
By: unacomsummer
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Stem Cell Research- Olivia Bishop - Video
Posted: March 13, 2014 at 8:41 pm
STEM CELL (indo)
Growth factor stem cell adult.
By: Dian Ytkp
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STEM CELL (indo) - Video
Posted: March 13, 2014 at 8:40 pm
Bryan Anderson Combined Stroke and Stem Cell Treatment
Bryan Anderson #39;s second round of Stem Cell Treatment from Dr. Steenblock #39;s Clinic in Mission Viejo, CA.
By: David Steenblock
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Bryan Anderson Combined Stroke and Stem Cell Treatment - Video
