In a boost for the field of regenerative medicine, a small biotechnology company has received regulatory approval in Canada for what it says is the first manufactured drug based on stem cells.
The company, Osiris Therapeutics of Columbia, Md., said Thursday that Canadian regulators had approved its drug Prochymal, to treat children suffering from graft-versus-host disease, a potentially deadly complication of bone marrow transplantation.
“It’s really a good day for the concept and the hope behind stem cell therapies becoming a reality,” C. Randal Mills, the chief executive of Osiris, said in an interview.
Prochymal is a preparation of mesenchymal stem cells, which are obtained from the bone marrow of healthy young adult donors. The stem cells are separated out from the marrow and expanded in culture, so that one donation is enough to make as many as 10,000 doses.
Because these are adult stem cells, they do not raise the ethical concerns of embryonic stem cells, whose creation usually involves the destruction of human embryos.
Graft-versus-host disease occurs when the immune cells in a bone-marrow transplant see the recipient’s organs as foreign and attack them, causing potentially severe damage to the skin, liver and digestive tract. This happens most often when the donor is not an exact match for the recipient.
Doctors try using steroids or other drugs to damp the immune attack, but in many cases those don’t work, and the patient may die.
Prochymal is approved in Canada for children whose condition is not controlled by steroids. In a small trial, about 60 percent of such children had a clinically meaningful response to the drug, Osiris said.
“Any drug or a cell that has activity in the patients with severe disease is exciting and important,” said Dr. Joanne Kurtzberg, director of the pediatric blood and marrow transplant program at Duke University Medical Center.
Dr. Kurtzberg, who helped Osiris present its case to Canadian regulators, said the drug has saved some children’s lives from graft-versus-host disease and could lead to more successful bone marrow transplants.
Osiris is not expected to gain much revenue from patients with a rare disease in Canada. But it is a welcome success for a 20-year-old company that has had its share of failures.
In 2009, Prochymal failed in two late-stage clinical trials, showing little to no advantage over placebo in treating graft-versus-host disease. The company is also trying to develop Prochymal as a treatment for Crohn’s disease, diabetes, heart attacks and other illnesses, but has had some failures there as well.
Sanofi, the big French company that had the rights to sell Prochymal outside North America, said in February that it had discontinued its work on the drug.
Dr. Mills, Osiris’s chief executive, said the company realized the drug was most effective in the most severe cases of graft-versus-host-disease that did not respond to steroids, leading it to do the small trial in children.
Dr. Mills said that the Food and Drug Administration indicated that it would require more data before approval, prompting Osiris to seek approval in Canada first. He said the company would apply to the F.D.A. later this year.
Stem cells are already used in medicine. Bone marrow or stem cell transplants are used to treat various cancers and genetic diseases. But those transplants are medical procedures, not products sold by a drug company.
There are cell therapies that have been approved by regulators, such as Carticel, a Genzyme product that uses a patient’s own cells to repair cartilage in injuries. Last year the F.D.A. approved a cord blood product for use in transplantation. Those products are not manufactured for off-the-shelf use like Prochymal is, Dr. Mills said.
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Researchers in Australia have found stem cells in breast milk that, like embryonic stem cells, can become many different types of cells in the body.
Dr Foteini Hassiotou and the Hartmann Human Lactation Research Group at the University of Western Australia have found stem cells in human breast milk that they have turned into bone, brain, liver, and pancreatic cells that produce insulin.
From ABCScience.com:
A solution to the ethical dilemma of using human embryonic stem cells to treat human diseases could be staring us in the face.
Five years ago, Dr Foteini Hassiotou was part of a research team, the Hartmann Human Lactation Research Group at the University of Western Australia, which discovered that human breast milk contains what appear to be stem cells. These cells can potentially turn into many different types of cells, and offer staggering potential for treating a huge range of human diseases.
Hassiotou, the newest member of the group, found that some of these stem cells are very similar to embryonic stem cells — the most potent and useful stem cell of all.
Except the “potent and useful” stem cells found in breast milk do not require the destruction of human embryos to harvest them like embryonic stem cells. The stem cells in human breast milk are easily collected without surgery. The next step would be to investigate how these adult stem cells behave in animal models.
Human breast milk may be more than just nourishment for newborns. It may contain hope for a multitude of diseases. Hope that does not require the destruction of innocent human life.
Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences’ clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx™ Physician Network.
Regenerative Sciences’ Regenexx procedures utilize a patient’s own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.
“We are proud of our accomplishments in the field of regenerative interventional orthopedics and it’s exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist,” said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. “Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use.”
Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.
About Regenerative Sciences
Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: www.regenexx.com
About John C. Malone, PhD
Dr. John C. Malone holds a bachelor’s degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master’s degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.
Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.
How to Release MORE Adult Stem Cells .. go to EJMorris.biz .. If a person stimulates the body to Release MORE stem cells from the bone marrow, the body can repair and renew itself, at a Faster pace than it might by dying. Negative changes in the body, due to illness, accident or simply going through process of aging.. results in less adult stem cells circulating in the blood stream. Fact The more adult stem cells in the bloodstream are, the better it is for the body.. the closer you are to achieving optimal health. Fact: The older the body becomes.. MORE adult Stem Cells are required for repair and Renewal. And, the sad fact is.. as the body AGES .. the body has LESS stem cells in blood circulation for renewal ,repair and rejuvenation. The World’s FIRST Adult stem cell nutrition that releases, into circulation into the blood stream, millions more adult stem cells that are “Stuck” in the bone marrow is phenomenon that adult stem cell scientists and researchers have discovered. It has been proven our OWN adult stem cells.. the stem cells that are present in our body from the Minute we are born, constitute our body’s natural RENEWAL SYSTEM. Witness the world’s first adult stem cell enhancer nutrition products available in capsules, tablets, powders, granules and skin care serum … www.EJMorris.info
Polymer scaffolds guide stem cells growth into customized sizes and shapes.
It may be hard to remember what it was like to lose a tooth as a child, but many adults get an unpleasant reminder as they age when their teeth begin to fall out (even those who don’t play hockey) and must consider dentures or dental implants. For years, researchers have investigated stem cells in an effort to grow teeth made for a person’s own cells. Toward this end, endodontics professor Dr. Peter Murray and colleagues from the College of Dental Medicine at Nova Southeastern University (NSU) have developed methods to control adult stem cell growth toward generating dental tissue and “real” replacement teeth.
The NSU researchers’ approach is to extract stem cells from oral tissue, such as inside a tooth itself, or from bone marrow. After being harvested, the cells are mounted to a polymer scaffold in the shape of the desired tooth. The polymer is the same material used in bioreabsorable sutures, so the scaffold eventually dissolves away. Teeth can be grown separately then inserted into a patient’s mouth or the stem cells can be grown within the mouth reaching a full-sized tooth within a few months.
So far, teeth have been regenerated in mice and monkeys, and clinical trials with humans are underway, but whether the technology can generate teeth that are nourished by the blood and have full sensations remains to be seen. Teeth present a unique challenge for researchers because the stem cells must be stimulated to grow the right balance of hard tissue, dentin and enamel, while producing the correct size and shape.
As Dr. Murray explains it, humans already have two sets of teeth, baby and adult sets, over the course of their lifetimes, so “All we are trying to do is copy nature and give the person the third option to re-grow their teeth.” Not only could this be important for replacing lost teeth, but it could become a standard treatment when extreme orthodontics is necessitated. And if the tooth is malformed or fails, it can be extracted and a new one put into place.
To date, the NSU researchers have received about $1.7 million in grants for their dental stem cell research.
Dr. Murray believes that if they can demonstrate control over tooth re-growth and prove that the technology is safe, these teeth will be the first to see widespread adoption in the US. He also reports that interest has been high from the public and even fellow dentists, as evidenced by the recent selling out of his “Regenerative Endodontic Procedures” presentation at the American Dental Association conference in Las Vegas.
Just as developments in embryonic stem cell research launched umbilical cord banks, the promise that dental stem cell therapy holds has led to the rise of tooth banks, such as BioEden, StemSave, and Store-A-Tooth (StemSave, for instance, charges $2,430 to store a child’s tooth for 20 years.) Stem cell therapies are being actively used to repair bone damage, facial bones, and even organs like a heart, but skeptics continue to scoff at the potential of stem cells, oft citing nightmare scenarios or runaway tissue growth. Furthermore, research progress is often clouded by the politics surrounding embryonic stem cell research.
But the one therapy that could silence the naysayers is tooth regeneration.
The statistics on tooth loss are a bit staggering: 7 out of 10 adults age 35 to 44 have lost at least one tooth and a quarter of those aged 65 or older (or about 20 million people) have lost all their permanent teeth. Additionally, side effects from medications can effect oral health, such as changing properties of the saliva that helps fight bacterial growth. And increased tooth loss leads to poor dietary habits even among dentists, according to a recent study, which leads to secondary health effects. Add to this high sugar diets contributing to the obesity epidemic and increasing cases of periodontal disease due to neglect and you can see that the market for tooth replacement is enormous and expected to grow.
Having a full set of functional teeth is increasingly important as an aging population seeks to maintain an active lifestyle. And the growth of social media has led to people’s faces being plastered all over Facebook, Twitter, and YouTube. So how your teeth look is more important than ever, especially with more people carrying high quality cameras built into their mobile devices.
Dentists are at the front line of the increased demand for perfect teeth. A 2009 nationwide survey by NSU revealed that 96% of the dentists polled expected stem cell regeneration to dominate the future of dentistry. Additionally, more than half predicted that the technology would be available within the next decade.
Research into using stem cells to regrow new teeth has been around for at least 10 years. In 2002, Professor Paul Sharpe at the Dental Institute of King’s College in London received a $500,000 Wellcome Trust grant to translate tooth regrowth with stem cells in mice into regenerative dentistry for humans. A company was formed, Odontis, and in 2010 seemed ready to launch its BioTooth technology, but has since fallen off the radar and had its website shut down possibly suffering the same fate that led to Geron Corporation abandoning stem cell research last year. Researchers from Tokyo University in 2009 reported success with implantation of stem cell tooth germs in mice which grew into fully functional teeth within a few months. Scaffolds were also successfully used to regrow anatomically correct teeth in nine weeks by researchers at Colombia University Medical Center.
Although the promise of stem cell therapies remains to be realized, there’s little doubt that researchers at NSU and around the world will continue in their efforts to use stem cells for regenerative medicine.
Dr. Murray remains optimistic: “When dental stem cell therapies become routine it will be historic, and the most fantastic time to practice as a dentist.”
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www.EmergentStemCells.com There are two kinds of stem cells embryonic and adult. Much of the emphasis in the mainstream media is on embryonic stem cells; however adult stem cells can treat more than 70 different medical conditions. These adult stem cells can develop into a wide range of tissues in the human body. Embryonic stem cells are obtained after killing the human embryo, whereas adult stem cells are located throughout the human body and can be safely extracted without doing any harm. There is a new breakthrough in stem cell technology. With the use of plant-based stem cell nutrition, the number of adult stem cells can increase without surgery or painful injections. JDI and Vita-Stim contains Stem Cell Nutrition. Go to www.emergentstemcells.com This video presents the Catholic Church’s teaching on human life as it relates to adult and embryonic stem cell research — courtesy of the Michigan Catholic Conference.
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Fourth in a series of short videos brought to you by the Maryland Coalition for Ethical Research. This is lesson 4 describing induced pluripotent stem cells.
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