Stem Cell Therapy for Erectile Dysfunction - Alvarado Hospital
The first study in the U.S. to determine if stem cell therapy can treat erectile dysfunction. Alvarado Hospital #39;s Drs. Irwin Goldstein and Barry Handler discuss this FDA-approved study and...
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Stem Cell Therapy for Erectile Dysfunction - Alvarado Hospital - Video
Creation Of Rejuvenated Cell By Stem Cell Therapy - The Line Clinic
Stem cell therapy has become reality which was just possibilities and thoughts of science few days before. This amazing innovation makes life more secured an...
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Creation Of Rejuvenated Cell By Stem Cell Therapy - The Line Clinic - Video
PRESS RELEASE
TiGenix and Lonza sign agreement for the manufacture of stem cell-based treatment of complex perianal fistulas in Crohn's disease
TiGenix's Cx601 product is currently in Phase 3 in Europe for the treatment of complex perianal fistulas in Crohn's disease
Lonza to manufacture Cx601 product for TiGenix's Phase 3 trial in the US at Lonza's Walkersville, Maryland (US) facility
Basel, Switzerland, and Leuven, Belgium, 12 February 2015 - Lonza, a global leader in biological and cell therapy manufacturing and TiGenix, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) in inflammatory and autoimmune diseases, announced today an agreement for the supply of TiGenix's eASC product, Cx601. Under the agreement, Lonza will manufacture material for the Phase 3 trial of Cx601 in the US at Lonza's cell therapy production facility in Walkersville, Maryland (US).
Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn's disease patients, currently in Phase 3 of clinical development in Europe. Following the positive feedback received at a meeting with the Center for Biologics Evaluation and Research within the US Food and Drug Administration (FDA), TiGenix is moving ahead with the development of Cx601 for the US market. To supply Cx601 for a Phase 3 trial in the US, and potentially for the US market when the product has been fully approved, TiGenix has chosen to partner with Lonza as its contract manufacturing organisation (CMO). TiGenix will begin the process of technology transfer to Lonza in the coming weeks.
In December 2014, TiGenix submitted to the FDA the required documentation for a Special Protocol Assessment (SPA) of its pivotal Phase 3 trial design for Cx601 in the treatment of complex perianal fistulas in patients with Crohn's disease in the US. Agreement with the FDA on the SPA will ensure that the trial design is aligned with the FDA's requirements for the future approval of Cx601. The Phase 3 trial in the US, if successful, together with positive data from the European Phase 3 trial, would enable TiGenix to file a Biologics License Application (BLA) with the FDA.
"It was critical for us to have secured an agreement with a leading CMO, like Lonza, for Cell Therapy Manufacturing," said Eduardo Bravo, CEO of TiGenix. "With our appointment of a US advisory board in gastroenterology and inflammatory bowel disease, our submission to the FDA for an SPA for our US Phase 3 trial design, and now the agreement with Lonza for our US-based manufacturing, we have completed the early steps to prepare Cx601 for approval and entry in the American market."
"We are pleased to partner with TiGenix for the production of Cx601. Lonza will utilise our manufacturing knowledge and world class quality systems to manufacture this potentially life- changing product for Crohn's disease patients with complex perianal fistulas", said David Smith, Head of Cell Therapy, Lonza Custom Manufacturing. "Lonza is looking forward to a long and productive partnership with TiGenix."
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Newswise MINNEAPOLIS Stem cell transplants may be more effective than the drug mitoxantrone for people with severe cases of multiple sclerosis (MS), according to a new study published in the February 11, 2015, online issue of Neurology, the medical journal of the American Academy of Neurology.
The study involved 21 people whose disability due to MS had increased during the previous year even though they were taking conventional medications (also known as first-line treatments). The participants, who were an average age of 36, were at an average disability level where a cane or crutch was needed to walk.
In MS, the bodys immune system attacks its own central nervous system. In this phase II study, all of the participants received medications to suppress immune system activity. Then 12 of the participants received the MS drug mitoxantrone, which reduces immune system activity. For the other nine participants, stem cells were harvested from their bone marrow. After the immune system was suppressed, the stem cells were reintroduced through a vein. Over time, the cells migrate to the bone marrow and produce new cells that become immune cells. The participants were followed for up to four years.
This process appears to reset the immune system, said study author Giovanni Mancardi, MD, of the University of Genova in Italy. With these results, we can speculate that stem cell treatment may profoundly affect the course of the disease.
Intense immunosupression followed by stem cell treatment reduced disease activity significantly more than the mitoxantrone treatment. Those who received the stem cell transplants had 80 percent fewer new areas of brain damage called T2 lesions than those who received mitoxantrone, with an average of 2.5 new T2 lesions for those receiving stem cells compared to eight new T2 lesions for those receiving mitoxantrone.
For another type of lesion associated with MS, called gadolinium-enhancing lesions, none of the people who received the stem cell treatment had a new lesion during the study, while 56 percent of those taking mitoxantrone had at least one new lesion.
Mancardi noted that the serious side effects that occurred with the stem cell treatment were expected and resolved without permanent consequences.
More research is needed with larger numbers of patients who are randomized to receive either the stem cell transplant or an approved therapy, but its very exciting to see that this treatment may be so superior to a current treatment for people with severe MS that is not responding well to standard treatments, Mancardi said.
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Stem Cell Transplants May Work Better than Existing Drug for Severe Multiple Sclerosis
Stem-cell advocates pin their hopes on an artificial pancreas to treat diabetes.
Fourteen years ago, during the darkest moments of the stem-cell wars pitting American scientists against the White House of George W. Bush, one group of advocates could be counted on to urge research using cells from human embryos: parents of children with type 1 diabetes. Motivated by scientists who told them these cells would lead to amazing cures, they spent millions on TV ads, lobbying, and countless phone calls to Congress.
Now the first test of a type 1 diabetes treatment using stem cells has finally begun. In October, a San Diego man had two pouches of lab-grown pancreas cells, derived from human embryonic stem cells, inserted into his body through incisions in his back. Two other patients have since received the stand-in pancreas, engineered by a small San Diego company called ViaCyte.
Its a significant step, partly because the ViaCyte study is only the third in the United States of any treatment based on embryonic stem cells. These cells, once removed from early-stage human embryos, can be grown in a lab dish and retain the ability to differentiate into any of the cells and tissue types in the body. One other study, since cancelled, treated several patients with spinal-cord injury (see Geron Shuts Down Pioneering Stem-Cell Program and Stem-Cell Gamble), while tests to transplant lab-grown retina cells into the eyes of people going blind are ongoing (see Stem Cells Seem Safe in Treating Eye Disease).
Type 1 diabetes is especially hard on children. If they dont manage their glucose properly, they could suffer nerve and kidney damage, blindness, and a shortened life span.
Type 1 patients must constantly monitor their blood glucose using finger pricks, carefully time when and what they eat, and routinely inject themselves with insulin that the pancreas should make. Insulin, a hormone, triggers the removal of excess glucose from the blood for storage in fat and muscles. In type 1 diabetics, the pancreas doesnt make it because their own immune system has attacked and destroyed the pancreatic islets, the tiny clusters of cells containing the insulin-secreting beta cells.
The routine is especially hard on children, but if they dont manage their glucose properly, they could suffer nerve and kidney damage, blindness, and a shortened life span. Yet despite years of research, there is still just nothing to offer patients, says Robert Henry, a doctor at the University of California, San Diego, whose center is carrying out the surgeries for ViaCyte.
Henry slightly overstates the case, but not by much. There is something called the Edmonton Protocol, a surgical technique first described in the New England Journal of Medicine in 2000. It used islets collected from cadavers; by transplanting them, doctors at the University of Alberta managed to keep all seven of their first patients off insulin for an entire year.
Early hopes for the Edmonton Protocol were quickly tempered, however. Only about half of patients treated have stayed off insulin long-term, and the procedure, which is still regarded as experimental in the U.S., isnt paid for by insurance. It requires recipients to take powerful immune-suppressing drugs for life. Suitable donor pancreases are in extremely short supply.
The early success of the Edmonton Protocol came only two years after the discovery of embryonic stem cells, in 1998. Those pressing for a diabetes cure quickly set a new goal: pair something like the Edmonton Protocol with the technology of lab-grown beta cells, the supplies of which are theoretically infinite.
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A Pancreas in a Capsule
Structure of a typical neuron, showing the protective myelin sheath that is attacked in multiple sclerosis
In what could herald a major advance in treating multiple sclerosis, brain damage was significantly reduced in patients getting stem cell transplants, compared to a control group. Results of the small Phase 2 trial -- the first of its kind -- are preliminary but promising, according to experts not involved with the trial.
The four-year study compared the results of intense immune suppression followed by transplants of the patient's own blood-forming, or hematopoietic stem cells to those of a control group given immune suppression alone. Dr. Giovanni L. Mancardi of the University of Genova in Italy led the 21-patient study, released Wednesday in the journal Neurology.
Patients in the treatment group had 80 percent fewer new damaged brain areas called T2 lesions, compared to those who got the immune-suppressing chemotherapy drug mitoxantrone but no stem cells. The Phase 3 trial will look for signs of effectiveness in reducing disability. The goal is to "reboot" the immune system, which is maladjusted in MS and attacks the nervous system, impairing movement and balance.
Patients were randomly assigned to either the treatment or control group, something that hasn't been done in previous trials of stem cell therapy for MS, according to an accompanying editorial in Neurology.
Randomizing patient assignment gives the results more value, said UC San Diego stem cell researcher Larry Goldstein and neurologist Dr. Jody Corey-Bloom.
"It's a very exciting advance," said Goldstein, who heads UCSD's stem cell program. "It's a small study, but it sure looks like it was well controlled and carefully done."
Goldstein and Corey-Bloom, and the study authors themselves, cautioned that because the trial was so small, results must be regarded as preliminary. No improvement in disability was found in the trial, although there were so few patients that even a strong benefit might not have been noticed.
The Phase 3 trial now underway, which will include more patients, has been designed to find that benefit, if it exists. It can be found at clinicaltrials.gov under the identifier NCT00273364.
In the Phase 2 trial, nine patients received immune suppression followed by stem cell transplants. Immune suppression alone was administered to a control group of 12 patients, for a total of 21 patients. The patients receiving stem cells were given their own, or autologous, hematopoietic stem cells, reducing the risk of rejection.
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Stem cells reduce MS brain damage
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Newswise A University of California, San Diego School of Medicine project involving the creation of miniature models of the human brain developed with stem cells to study neurological disorders caused by HIV and methamphetamine use has been named one of five recipients of the 2015 Avant-Garde Award for HIV/AIDS Research from the National Institute on Drug Abuse (NIDA).
The project, headed by Tariq M. Rana, PhD, professor of pediatrics, will receive $500,000 per year for five years.
The human cerebral cortex has evolved strikingly compared to those of other species, and no animal model accurately captures human-specific brain functions, said Rana. The creation of mini-brains, or organoids, will permit, for the first time, study of the toxic effects of addiction and HIV on the human brain in a dish. This offers us the exciting opportunity to design patient-specific model systems, which could potentially revolutionize drug discovery and precision medicine for central nervous system disorders.
The Avant-Garde Awards are granted to scientists who propose high-impact research that could open new avenues for prevention and treatment of HIV/AIDS among drug abusers. The term avant-garde is used to describe highly innovative approaches that have the potential to be transformative.
Despite the success of combined antiretroviral therapies, HIV remains a chronic disease with a host of debilitating side effects that are exacerbated in those suffering from substance use disorders, said NIDA director Nora D. Volkow, MD. These scientists have proposed creative approaches that could transform the way we think about HIV/AIDS research, and could lead to the development of exciting new tools and strategies to prevent infections and improve the lives of substance abusers infected with HIV.
The other 2015 recipients are:
*Don C. Des Jarlais, PhD, Mount Sinai Beth Israel *Eli Gilboa, PhD, University of Miami School of Medicine *Nichole Klatt, PhD, University of Washington, Seattle *Alan D. Levine, PhD, Case Western Reserve University
For more information about the Avant-Garde Award Program and 2015 recipients, visit http://www.drugabuse.gov/about-nida/organization/offices/office-nida-director-od/aids-research-program-arp/avant-garde-award-hivaids-research
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Building Mini-Brains to Study Disorders Caused by HIV and Meth Use
Editors note: Upon request, some individuals interviewed for this article have been identified by first name only.
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The Statement is The Michigan Daily's weekly news magazine, distributed every Wednesday during the academic year.
It is exciting for me to think that this tiny group of cells could be the seed to help people suffering with diseases in the future, Patricia said.
In the Medical Science Building at the Universitys Medical School, I looked through a microscope at a 35-millimeter petri dish and saw microscopic organisms that could apparently one day provide treatments for a host of debilitating genetic diseases.
These microscopic organisms are called human embryonic stem cell colonies.
The room is the Universitys MStem Cell Laboratories, which develops human embryonic stem cell lines from disease-affected embryos. Last month The Michigan Daily reported on one such stem cell line developed from an embryo that had been donated by a University alumna.
But as the University looks to grow such efforts, it remains unclear how the current political landscape might alter the path of such research.
***
The difficulty in studying genetic diseases is observing how they begin and how they grow. Without access to the formation of the cells, scientists cannot know what the developmental process is. Embryonic stem cell lines can to some extent solve this problem by showing scientists how a mutation develops.
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University advances stem cell technologies amid political contention
Portland, Oregon and Miami, Fla. (PRWEB) February 10, 2015
Global Stem Cells Group and the Regenerative Technology Alliance (RTA) have signed a memorandum of understanding to evaluate and promote stem cell training programs. RTA, a global provider of standards and certification for the emerging fields of regenerative medicine and science, will work with the Global Stem Cells Group to evaluate the regenerative medicine companys training programs and assess GSCGs participating physicians against the RTAs established international standards for the practice of regenerative and cell-based medicine.
Our new alliance with the RTA is a natural step toward establishing GSCGs recognition as a global leader in stem cell medicine, says Global Stem Cells Group CEO Benito Novas. This is a perfect fit for us, as Global Stem Cells Group shares the RTAs focus on high standards and transparency, especially when it comes to patient safety and advancing the field of stem cell medicine.
We are very pleased to have this alliance, says David Audley, General Secretary and Chair of the RTA. Our goal is to provide the highest level of transparency and oversight for the industry. Working with Global will allow us to have a direct and dramatic impact on physician training.
For more information, visit the Global Stem Cells Group website, email bnovas(at)stemcellsgroup(dot)com, or call 305-224-1858.
About Global Stem Cells Group:
Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products, and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators, and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions. With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.
About the RTA
The Regenerative Technology Alliance (RTA) a global provider of standards and certification for the emerging fields of regenerative medicine and science, is a 501(c)3 and is supported by donations from individuals, corporations and foundations to help advance its critical mission of bringing peer oversight and transparency to the field of cell-based and regenerative medicine.
For more information visit the RTA website, email david(at)regen-tech(dot)org, or call 503-446-5039.
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Global Stem Cells Group Announces Alliance with Regenerative Technology
DUBLIN, Feb .10, 2015 /PRNewswire/ --Research and Markets
(http://www.researchandmarkets.com/research/7zf9mz/cell_therapy) has announced the addition of Jain PharmaBiotech's new report "Cell Therapy - Technologies, Markets and Companies" to their offering.
This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.
Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.
Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.
Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.
Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.
The cell-based markets was analyzed for 2014, and projected to 2024.The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.
The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 294 of these are profiled in part II of the report along with tabulation of 285 alliances. Of these companies, 160 are involved in stem cells. Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 61 Tables and 16 Figures. The bibliography contains 1,200 selected references, which are cited in the text.
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Cell Therapy Report 2014-2020 - Technologies, Markets and Companies