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Main Category: Neurology / Neuroscience
Also Included In: Stem Cell Research;  Rehabilitation / Physical Therapy
Article Date: 04 Feb 2012 - 10:00 PST

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The February edition of Neurosurgery reports that animal experiments in brain-injured rats have shown that stem cells injected via the carotid artery travel directly to the brain, greatly enhancing functional recovery. The study demonstrates, according to leading researcher Dr Toshiya Osanai, of Hokkaido University Graduate School of Medicine in Sapporo, Japan, that the carotid artery injection technique could, together with some form of in-vivo optical imaging to track the stem cells after transplantation, potentially be part of a new approach for stem cell transplantation in human brain trauma injuries (TBI).

Dr. Osanai and team assessed a new "intra-arterial" technique of stem cell transplantation in rats, with the aim of delivering the stem cells directly to the brain without having to go through the general circulation. They induced TBI in the animals before injecting stem cells into the carotid artery seven days later.

The stem cells were obtained from the rats' bone marrow and were labeled with "quantum dots" prior to being injected. Quantom dots are a biocompatible, fluorescent semiconductor created with nanotechnology that emit near-infrared light with much longer wavelengths that penetrate bone and skin, enabling a non-invasive method of monitoring the stem cells for a period of four weeks following transplantation.

This in vivo optical imaging technique enabled the scientists to observe that the injected stem cells entered the brain on the first attempt, without entering the general circulation. They observed that the stem cells started migrating from the capillaries into the injured part of the brain within three hours.

At week 4, the researchers noted that the rats in the stem cell transplant group achieved a substantial recovery of motor function, compared with the untreated animals that had no signs of recovery.

The team learnt, after examining the treated brains, that the stem cells had transformed into different brain cell types and aided in healing the injured brain area.

Over the last few years, the potential of stem cell therapy for curing and treating illnesses and conditions has been growing rapidly. Below is a list of some of its possible uses.

Stem cells represent a potential, new important method of treatment for those who suffered brain injuries, TBI and stroke. But even though bone marrow stem cells, similar to the ones used in the new study, are a promising source of donor cells, many questions remain open regarding the optimal timing, dose and route of stem cell delivery.

In the new animal study, the rats were injected with the stem cells one week after TBI. This is a "clinically relevant" time, given that this is the minimum time it takes to develop stem cells from bone marrow.

Transplanting the stem cells into the carotid artery is a fairly simple procedure that delivers the cells directly to the brain.

The experiments have also provided key evidence that stem cell treatment can promote healing after TBI with a substantial recovery of function.

Dr. Osanai and team write that by using in vivo optical imaging:

"The present study was the first to successfully track donor cells that were intra-arterially transplanted into the brain of living animals over four weeks."

A similar form of imaging technology could also prove beneficial for monitoring the effects of stem cell transplantation in humans, although the tracking will pose challenges, due to the human skull and scalp being much thicker than in rats.

The researchers conclude:

"Further studies are warranted to apply in vivo
optical imaging clinically."

Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our neurology / neuroscience section for the latest news on this subject. "Therapeutic Effects of Intra-Arterial Delivery of Bone Marrow Stromal Cells in Traumatic Brain Injury of Rats—In Vivo Cell Tracking Study by Near-Infrared Fluorescence Imaging"
Osanai, Toshiya; Kuroda, Satoshi; Sugiyama, Taku; Kawabori, Masahito; Ito, Masaki; Shichinohe, Hideo; Kuge, Yuji; Houkin, Kiyohiro; Tamaki, Nagara; Iwasaki, Yoshinobu
Neurosurgery. 70(2):435-444, February 2012. doi: 10.1227/NEU.0b013e318230a795 Please use one of the following formats to cite this article in your essay, paper or report:

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Treating Brain Injuries With Stem Cell Transplants - Promising Results

Uncategorized Comments Off on Treating Brain Injuries With Stem Cell Transplants – Promising Results | February 5th, 2012

The Hindu Prof. Shinya Yamanaka of Centre for iPS Cell Research and Application, Japan, delivering a lecture in New Delhi on Friday. Photo: R.V.Moorthy

Renowned Japanese scientist Shinya Yamanaka, who achieved a major breakthrough in the emerging area of stem cell research by creating a possible alternative to embryonic stem cells in 2007, expressed confidence here on Friday that drugs would be available soon for diseases for which therapies are yet to be found.

Delivering a lecture on “New Era of Medicine with iPS Cells” organised jointly by Cell Press and TNQ Books and Journals, Prof. Yamanaka said the cells -- “induced pluripotent stem cells [iPS Cells]'' -- developed by him and his team would not only help overcome the ethical issues surrounding use of embryonic stem cells for treatment of diseases like spinal cord injuries, Type I diabetes or macular diseases but also help in development of drugs for conditions like motor neuron disease.

Embryonic stem cell therapy is considered important as it offers immense possibilities for treatment of a wide range of diseases and conditions since the cells proliferaterapidly and are pluripotent or possess the capability to differentiate into any type of cell, said Prof. Yamanaka. But it suffers from a major ethical issue as it involves use of live human embryos, Prof. Yamanaka pointed out. He said if there was a post-transplant rejection, they cannot be used from the patient's own cell.The iPS cells, on the other hand, are created from adult skin cells and do not have these two problems, while at the same time they provide for rapid proliferation and the possibility to differentiate into any type of cell, he said. Prof. Yamanaka and his team generated iPS mouse cells in 2006 and followed up with iPS cells developed from human skin cells in 2007.

Speaking about the potentials of iPS cells, he said studies using the cells for treatment of spinal cord injuries have already shown good results in mouse and monkey specimens and in two to three years scientists would be ready to go in for clinical trials. He, however, admitted that there are several challenges before the new technology. Its safety is yet to be proved completely and the process of deriving patient-specific iPS cells is time-consuming and expensive.

He expressed hope that scientists who are working on itwould overcome the challenges and a new era in medical treatment would emerge soon.

Union Human Resource Development Minister Kapil Sibal, who introduced him, said his Ministry along with the Ministries of Health and Science & Technology would take steps for Indian scientists to collaborate with him.

TNQ Books and Journals Managing Director Mariam Ram and Cell Press Executive Editor Emilie Marcus also spoke.

Link:
New era of medicine in the offing, says scientist

Uncategorized Comments Off on New era of medicine in the offing, says scientist | February 4th, 2012

Be The Match donor registry drive in Cokato Saturday

By Kristen Miller
News Editor

COKATO, MN – By age 14, Taylor Tenhoff had already been diagnosed with severe aplastic anemia and had undergone two bone marrow transplants; one that was unsuccessful.

Fortunately for Taylor’s sake, he was able to find a match in one of his six siblings. However, there are many patients in need of bone marrow transplants who don’t have a sibling match and rely Be The Match Registry, operated by the nonprofit, National Marrow Donor Program.

In an effort to raise awareness for the need of bone marrow donors, the Tenhoff family of Cokato is hosting a Be The Match donor registry drive Saturday, Feb. 11 from 9 a.m. to 1 p.m. in the community room of Cokato City Hall. It is also the one year anniversary of Taylor’s second bone marrow transplant.

“We want to increase the amount of donors available,” Taylor’s mother, Monica, said. “The more people that get on the registry, the more potential donors there are.”

In 2008, Katie (Tenhoff) Richter donated bone marrow to her brother, only for it to fail months later. She donated again last February.

“If I had to do it again, I would,” Katie said. “The feeling you get knowing he’s alive because of you is amazing.”

Thousands of patients with life-threatening diseases and blood cancers, such as leukemia, lymphoma, and sickle cell anemia depend on the Be The Match Registry to find a bone marrow match.

According to Be The Match, 70 percent of patients needing a marrow transplant do not have a matching donor within their family.

“Siblings are the best match, but it’s not always a guarantee . . that’s when the patient comes to us,” said Kristine Reed, account executive of recruitment and development for Be The Match, the only marrow registry in the US.

Unlike blood donations, bone marrow does not match according to blood type. Instead, matches are based on the same racial and ethnic background, Reed explained.

“Not a lot of people are aware of that,” she said. “Right now, we are extremely low on the registry of non-caucasion donors,” she added.

The matching process is extremely specific, Reed said. If the recipient’s body doesn’t recognize the marrow type, it will try and fight it, a fight that could actually be fatal, she said.

There are requirements and limits for being on the registry. Donors need to be between the ages of 18 and 60, be willing to donate to any patient in need, and meet the health guidelines.

Reed, who is a leukemia survivor and marrow transplant recipient since 1999, will be leading the registry Saturday. She recommends those interested in joining the registry learn more about it beforehand.

“We want to make sure they are comfortable and willing to donate when they get the call,” Reed said. “If they get the call, it’s because they match a patient who is dying.”

It also costs the organization roughly $100 every time someone is placed on the registry, Reed said, adding that donors are encouraged to give what they can.

The registry process is painless and only takes between 20 to 30 minutes. It includes completing a confidential consent form and a cheek swab. No blood is drawn.

How the bone marrow donation process works

Once the donor has been called upon, there are two possible ways for bone marrow to be drawn.

The most common process is the peripheral blood stem cell donation. Similar to donating plasma or platelets, this is a non-surgical procedure and is requested by doctors 76 percent of the time.

For five days before donation, the donor receives daily injections of a drug that increases blood-forming cells in the bloodstream. On the last day, the donor’s blood is removed through a needle in one arm and passed through a machine that separates out the blood-forming cells. The remaining blood is returned to the donor through the other arm.

The second process is a surgical procedure of marrow donation, and it is requested by doctors 24 percent of the time.

During this procedure, the donor is under anesthesia while the doctor uses a needle to withdraw liquid marrow from the back of the pelvic bone.

Once the marrow is drawn, it is immediately transported to the intended recipient.

Half of the donors on the registry benefit patients from another country, and half of the patients that come to the registry receive a donor from another country, Reed explained. “It works both ways,” she said.

Marrow donors can expect to feel some soreness in the lower back for a few days to several weeks. Reed describes the pain similar to having fallen after slipping on ice.

Marrow donors are typically back to their unusual routine tin two to seven days. All costs are the recipient’s responsibility.

“There could be temporary discomfort,” Reed said, “but keep in mind, you’re giving someone a second chance at life.”

The temporary discomfort the donor may experience doesn’t compare to what the recipient has to go through before the transplant, Reed said, who received her sister’s bone marrow 12 years ago.

Just to put it in perspective, the patient needs full body radiation and intense chemotherapy to eradicate as much existing marrow as possible to make room for new, healthy marrow, Reed explained. “It’s like draining out a tank of gas,” she said.

Even after the transplant, there is a long road to recovery for the recipient, she commented.

To become a potential donor:

For those interested in being on the Be The Match Registry, visit http://www.tinyurl.com/TaylorTenhoff to learn more about becoming a donor.

To register, come to the donor registry drive Saturday, Feb. 11 from 9 a.m. to 11 p.m. at Cokato City Hall. Baked goods will be available with a free will offering and Dairy Queen coupons will be given to anyone who donates to the cause.

If becoming a donor isn’t a possibility, there is still an opportunity to donate cash toward the cause, which will be used to help cover lab costs associated with being on the registry.

More information can be found on http://marrow.org.

Read more:
Becoming a bone marrow donor could save a life

Bone Marrow Stem Cells Comments Off on Becoming a bone marrow donor could save a life | February 4th, 2012

(SACRAMENTO, Calif.) - Experts from UC Davis Health System will share the latest research about regenerative medicine, with a focus on chronic pain and the promise of stem cell therapies, during a community forum on the university's Sacramento campus. The discussion takes place on Tuesday, Feb. 7, from 6- 7:30 p.m. at the UC Davis Education Building, 4610 X Street, in Sacramento.

The event features Jan Nolta, director of the UC Davis Institute for Regenerative Cures; Scott Fishman, chief of the UC Davis Division of Pain Medicine; and Kee Kim, chief of spinal neurosurgery at UC Davis Medical Center. The three specialists will discuss the challenges of treating chronic pain, especially back and neck pain, and the clinical research now under way to use stem cell therapies to overcome it.

The forum is free and open to the public. It is part of "Stem Cell Dialogues," UC Davis Health System's discussion series about regenerative medicine and the goal of turning stem cells into cures. Each speaker will provide a short presentation followed by a panel discussion and question and answer period. The event will be moderated by Fred Meyers, professor of medicine and pathology, and executive associate dean of UC Davis School of Medicine.

Seating is limited. Those interested in attending must reserve a seat by contacting Kate Rodrigues at 916-734-9404 or e-mail kathleen.rodrigues@ucdmc.ucdavis.edu. Doors open at 5:30 p.m.  Free parking will be available in Lots 12 and 14, just south of the Education Building, near 45th Street and 2nd Avenue.

UC Davis is playing a leading role in regenerative medicine, with nearly 150 scientists working on a variety of stem cell-related research projects at campus locations in both Davis and Sacramento. The UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine (CIRM), opened in 2010 on the Sacramento campus. This $62 million facility is the university's hub for stem cell science. It includes Northern California's largest academic Good Manufacturing Practice laboratory, with state-of-the-art equipment and manufacturing rooms for cellular and gene therapies. UC Davis also has a Translational Human Embryonic Stem Cell Shared Research Facility in Davis and a collaborative partnership with the Institute for Pediatric Regenerative Medicine at Shriners Hospital for Children Northern California. All of the programs and facilities complement the university's Clinical and Translational Science Center, and focus on turning stem cells into cures. For more information, visit http://www.ucdmc.ucdavis.edu/stemcellresearch.

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The promise of stem cell therapies forum

Uncategorized Comments Off on The promise of stem cell therapies forum | February 4th, 2012

Do you remember when we used to think some things were impossible? Modern technology has taught us to never say never or impossible. I think about the 1970s and 1980s growing up without cell phones, computers and many of the electronically advanced gadgets that our kids today take for granted. I can’t even imagine what the great innovators will come up with next.

When I was a young child, I remember watching science fiction movies about cloning people and remember how obscure and unbelievable it seemed at the time. It was common knowledge that cloning was strictly science fiction. Now, cloning is not only possible, but a procedure that has occurred with astonishing success. Fortunately, cloning has only been performed with animals and not yet humans.

Medically speaking, one of the most popular and potentially one of the most substantial advances in modern medicine is stem cell research and therapy. Initially, stem cell research was met with a great deal of resistance and controversy. The reason stem cell research had trouble getting started was because stem cells could only be collected from fetuses. With time, scientists have successfully harvested stem cells from other sources.

Stem cells are primitive or extremely young cells which are capable of dividing and changing into a variety of cell types. They have the ability to develop into cells that form muscle, cartilage, bone or other tissues. One of the remarkable findings about stem cells is that they seem to detect and “know” which tissue is damaged and automatically change into the cells needing repaired.

In actuality, the damaged tissue sends some type of signal to the stem cells allowing them to respond and promote healing of the injured tissues. Essentially, stem cells have the ability to grow into mature tissue cells wherever they are needed and this makes them very useful for repairing certain body tissues damaged by injury, disease and possibly aging.

Stem cell treatment is a type of medical therapy called regenerative medicine. Regenerative medicine is simply a category of medical therapy pertaining to growing new tissue. Although stem cell therapy is an extremely unique and obviously beneficial type of medical treatment, it is also a very vast field of medical research and certainly has not been completely perfected. There are countless possibilities and applications for stem cell therapy and medical researchers have barely scratched the surface with regards to stem cell potential.

Until now the gold standard for treating arthritis in pets has been to give them anti-inflammatory medications, joint supplements and sometimes acupuncture. Over the years, these types of medications have improved greatly and pets have benefitted wonderfully from receiving this kind of treatment. However, even with the improvements, these medications have potential side effects. Sometimes, the side effects may even outweigh the benefits, depending on the individual circumstance.

Therefore, stem cell therapy offers treatment that doesn’t just relieve the symptoms, but actually regenerates or grows new tissue allowing for complete healing and without side effects. Presently, there are some stem cell applications already being used in veterinary medicine!

Recently, veterinary specialists have developed a technique for collecting stem cells from fat tissue and administering the stem cells into dogs, cats and horses specifically for treatment of arthritis. The process involves collecting a small amount of fat from the patient and then the fat is placed into a machine which extracts and concentrates stem cells. Next, the stem cells are injected back into the patient’s joints forthe treatment of arthritis.

There is a certain protocol for proceeding with the stem cell therapy. First, a definitive diagnosis of arthritis, using X-rays, must be made by your veterinarian. Additionally, your pet would need a complete workup including blood tests and additional X-rays to rule out any other disease processes such as infection or cancer. Any patient with cancer would not be a good candidate for stem cell therapy and any infection would need to be cleared prior to stem cell therapy.

Following the initial workup, your pet would be sedated or anesthetized for surgical collection of fat tissue. The fat tissue would then be sent to a lab to have the stem cells extracted and processed from the fat. Then, your pet would need to be sedated again to administer the injections containing the stem cells into their arthritic joints.

In pets, stem cell therapy is primarily available and being used for arthritis. However, I have no doubt that it won’t be long before stem cell therapy will be used in pets to treat many diseases and conditions. It has already shown to be effective for diabetes, allergies, gastrointestinal diseases, pancreatitis and many other diseases.

If you have a pet that you think might be suffering from arthritis, contact your veterinarian as soon as possible to consider stem cell therapy and to ensure your pet lives a long, healthy and happy life.

Link:
The Pet Corner: Behold! The future of modern medicine is here

Uncategorized Comments Off on The Pet Corner: Behold! The future of modern medicine is here | February 4th, 2012

By McClatchy-Tribune

STAMFORD — Justin Wexler, 12, a seventh-grader at Scofield Magnet Middle School, is asking Stamford residents to "be a super hero on Super Bowl Sunday" by registering to be a bone marrow donor.

Justin is hosting a donor drive at the Jewish Community Center, at 1035 Newfield Ave., from 10 a.m. to 2 p.m. on Sunday for his mitzvah project, a contribution to the community before his bar mitzvah.

"Don’t worry, there’s plenty of time to do this early in the day and get back home in time to watch the game," said Justin, who will be rooting for the Giants on Sunday.

The donor drive will take about six minutes for each participant from start to finish, he said, calmly spelling out the detailed process step-by-step as he sat at the head of his family’s dining room table Tuesday afternoon, his bright blue eyes shining.

"You walk into the JCC, and first you’ll come to a station and they’ll tell you the eligibility requirements ... then you fill out a basic registration form and go off to the swabbing station," he said. Each donor will then take a swab from the inside of their left and right cheek and wrap their samples up with their information.

"That’s it. It doesn’t take long," he said. "But think about what could come from it."

Justin came up with the idea for a bone marrow drive around Thanksgiving, as he and his mother reflected on his father’s experiences as a bone marrow donor for a woman in Long Island about two years ago. Justin’s grandfather also donated bone marrow before Justin was born. The idea that his family members were able to save others’ lives so easily stuck with him.

There are nearly 3 million potential donors registered with DKMS, the bone marrow donor center through which Justin will run his drive. But with a new diagnosis every four minutes, the donor reserves still aren’t enough; 60 percent of bone cancer patients never receive the transplants they need.

"It’s like finding a needle in a haystack," Justin said. His hope is that his drive will add 180 new names to that registry, and that someone will someday be a match for someone else in need. He chose the number 180 because it is a multiple of 18, a spiritual number in the Jewish faith that has strong ties to "life."

"It’s mitzvah, and trying to give someone else a life, so we thought 180 would be a good goal," he said. Continued...

While Justin said he is hoping to sign up scores of potential donors, he stressed that people should not register if they’re not absolutely certain they will be willing to go through with the transplant. He mentioned a boy around his age in Texas that he met around the holidays, who recently found a non-related donor for his second transplant after a transplant from his brother did not work as well as he and his doctors had anticipated.

"Imagine if they found him a match and then they said no," Justin said.

There are two ways to donate if a match is found. About 80 percent of the time, a donor’s blood is removed from one arm with a needle, blood stem cells are filtered out and the remaining blood is pumped back into the other arm. In the other method, marrow cells are collected from a donor using a special syringe.

The first option can often take two days, while the second takes about one or two hours in outpatient surgery. While flu-like side effects can occur for about 48 hours after the first option, donors usually experience some pain, bruising and stiffness for up to two weeks after the second option, according to DKMS.

"I think most people when they find out someone has cancer, they feel helpless, but this could be an opportunity to save someone’s life," said Justin’s mother, Robin Wexler.

Justin’s not old enough to swab his own cheeks for the cause — donors have to be between the ages of 18 and 55 — but he said he is glad to be helping by spreading the word.

"Maybe someone will show up on Sunday, someone who’s never even thought about doing this before, and maybe that person will be a match; maybe they’ll save a life," he said. "Imagine that."

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Stamford seventh-grader hosting bone marrow donor drive Super Bowl Sunday

Bone Marrow Stem Cells Comments Off on Stamford seventh-grader hosting bone marrow donor drive Super Bowl Sunday | February 3rd, 2012

ScienceDaily (Feb. 1, 2012) — Hepatitis C, an infectious disease that can cause inflammation and organ failure, has different effects on different people. But no one is sure why some people are very susceptible to the infection, while others are resistant.

Scientists believe that if they could study liver cells from different people in the lab, they could determine how genetic differences produce these varying responses. However, liver cells are difficult to obtain and notoriously difficult to grow in a lab dish because they tend to lose their normal structure and function when removed from the body.

Now, researchers from MIT, Rockefeller University and the Medical College of Wisconsin have come up with a way to produce liver-like cells from induced pluripotent stem cells, or iPSCs, which are made from body tissues rather than embryos; the liver-like cells can then be infected with hepatitis C. Such cells could enable scientists to study why people respond differently to the infection.

This is the first time that scientists have been able to establish an infection in cells derived from iPSCs -- a feat many research teams have been trying to achieve. The new technique, described this week in the Proceedings of the National Academy of Sciences, could also eventually enable "personalized medicine": Doctors could test the effectiveness of different drugs on tissues derived from the patient being treated, and thereby customize therapy for that patient.

The new study is a collaboration between Sangeeta Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and Electrical Engineering and Computer Science at MIT; Charles Rice, a professor of virology at Rockefeller; and Stephen Duncan, a professor of human and molecular genetics at the Medical College of Wisconsin.

Stem cells to liver cells

Last year, Bhatia and Rice reported that they could induce liver cells to grow outside the body by growing them on special micropatterned plates that direct their organization. These liver cells can be infected with hepatitis C, but they cannot be used to proactively study the role of genetic variation in viral responses because they come from organs that have been donated for transplantation and represent only a small population.

To make cells with more genetic variation, Bhatia and Rice decided to team up with Duncan, who had shown that he could transform iPSCs into liver-like cells.

Such iPSCs are derived from normal body cells, often skin cells. By turning on certain genes in those cells, scientists can revert them to an immature state that is identical to embryonic stem cells, which can differentiate into any cell type. Once the cells become pluripotent, they can be directed to become liver-like cells by turning on genes that control liver development.

In the current paper, MIT postdoc Robert Schwartz and graduate student Kartik Trehan took those liver-like cells and infected them with hepatitis C. To confirm that infection had occurred, the researchers engineered the viruses to secrete a light-producing protein every time they went through their life cycle.

"This is a very valuable paper because it has never been shown that viral infection is possible" in cells derived from iPSCs, says Karl-Dimiter Bissig, an assistant professor of molecular and cellular biology at Baylor College of Medicine. Bissig, who was not involved in this study, adds that the next step is to show that the cells can become infected with hepatitis C strains other than the one used in this study, which is a rare strain found in Japan. Bhatia's team is now working toward that goal.

Genetic differences

The researchers' ultimate goal is to take cells from patients who had unusual reactions to hepatitis C infection, transform those cells into liver cells and study their genetics to see why they responded the way they did. "Hepatitis C virus causes an unusually robust infection in some people, while others are very good at clearing it. It's not yet known why those differences exist," Bhatia says.

One potential explanation is genetic differences in the expression of immune molecules such as interleukin-28, a protein that has been shown to play an important role in the response to hepatitis infection. Other possible factors include cells' expression of surface proteins that enable the virus to enter the cells, and cells' susceptibility to having viruses take over their replication machinery and other cellular structures.

The liver-like cells produced in this study are comparable to "late fetal" liver cells, Bhatia says; the researchers are now working on generating more mature liver cells.

As a long-term goal, the researchers are aiming for personalized treatments for hepatitis patients. Bhatia says one could imagine taking cells from a patient, making iPSCs, reprogramming them into liver cells and infecting them with the same strain of hepatitis that the patient has. Doctors could then test different drugs on the cells to see which ones are best able to clear the infection.

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R. E. Schwartz, K. Trehan, L. Andrus, T. P. Sheahan, A. Ploss, S. A. Duncan, C. M. Rice, S. N. Bhatia. Modeling hepatitis C virus infection using human induced pluripotent stem cells. Proceedings of the National Academy of Sciences, 2012; DOI: 10.1073/pnas.1121400109

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Stem cells could drive hepatitis research forward

Skin Stem Cells Comments Off on Stem cells could drive hepatitis research forward | February 3rd, 2012

Morning After The Morning's Trash

In my last post, I focused on flaws in the medical device approval process. The Union of Concerned Scientists’ “FDA at a Crossroads” meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17. This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Some of us, naively, hoped that “change we can believe in” was real, having forgotten that the Tooth Fairy wasn’t.

Two of the speakers at the recent FDA at a Crossroads meeting were formerly at the FDA; both left because of political pressures. Dr. David Ross, was an FDA reviewer for Ketek (an antibiotic). In a Congressional hearing, Dr. Ross testified that he had been pressured to soften his findings about liver toxicity due to the drug and threatened by FDA Commissioner von Eschenbach, who said, “If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,” according to Ross.

The other was Dr. Susan Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, who resigned from the FDA after Plan B’s approval was initially denied.

The Tradition of Politics at the FDA

Before we delve into the specific discussion of Plan B, let’s look at the context of the politicization of the FDA, under the recent Bush administration in particular, which led to the characterization of the “broken FDA.” During that period access to healthcare information, health services, and medical research became limited by two growing trends: the infusion of increasingly restrictive religious doctrines and the implementation of ideology-driven—rather than scientific, evidence-based—public policies. Initially, access to science-based information was limited through censorship and even distortion in government sources (e.g., data regarding the efficacy of condoms in preventing HIV infections and STDs were removed from the CDC’s Web site). This neither helped reduce the teen birthrate nor STDs. They used the same misinformation tactic with the now discredited breast cancer-abortion link.

Ideologic shifts were also demonstrated by resource allocations. For example, HIV prevention programs at the CDC were reduced by $4 million while funding for abstinence-only programs rose from $20 million to $167 million, despite the lack of evidence of effectiveness, in contrast to the previous peer-review, scientific-merit-based process of NIH grant funding. No federal money is spent on comprehensive sex education. Even worse, since 1982, “Over $1 billion in government funding has been granted to abstinence-only programs…[which] are expressly forbidden from discussing contraception…and often contain factually inaccurate and distorted information. Those who design and operate these programs are often inexperienced, religiously-motivated and frequently have close ties to the anti-abortion movement.”

The trend away from evidence-based medicine affects healthcare practitioners in numerous areas, ranging from patient education and disturbingly eroding standards of medical care to selection of research topics, grant writing, and the research funding process. Upon her dismissal from the President’s Council on Bioethics in 2004 for disagreeing with the administration’s stance on stem cell research, Dr. Elizabeth Blackburn, a prominent cancer researcher and one of only three full-time biomedical researchers on the council, wrote, “When prominent scientists must fear that descriptions of their research will be misrepresented and misused by their government to advance political ends, something is deeply wrong.” Among her many honors, incidentally, is the 2009 Nobel Prize in Medicine.

A brief history of the FDA commissioners and other key persons over the past 20 years illustrates politics at work in the FDA.

David Kessler (commissioner,1990–1997) took a great deal of heat for trying to have the FDA regulate tobacco products and for trying to gain approval for RU-486 (mifepristone).(He lost on both counts.) He was also notable for being appointed by President George H. W. Bush and retained by President Clinton.

Jane Henney (commissioner, 1998–2001), also appointed by Clinton, authorized FDA approval of RU-486. She was, not surprisingly, ousted when George W. Bush took office. She also tried to change business as usual by filling positions with career appointees rather than political ones, actively demonstrating her goal of “leading policy and making enforcement decisions based on science, not on political whims.”

An infamous nominee for chairing Bush’s FDA advisory panel on women’s health policy was Dr. W. David Hager, an obstetrician-gynecologist. He had helped prepare a “citizens’ petition” calling for the FDA to reverse its approval of RU-486. He was perhaps more widely known for his reported refusal to prescribe contraceptives to married women and as author of a book that “recommends specific Scripture readings and prayers for such ailments as headaches and premenstrual syndrome.” After the outcry of critics, he was not appointed chair of the advisory panel but did serve on it in 2002–2005, despite bipartisan opposition.

Mark McClellan (commissioner, 2002–2004) was an economist appointed by George W. Bush. McClellan reportedly had decided against approving Plan B for emergency contraception even before his staff completed its analysis.

Lester Crawford (commissioner, July–September 2005) was a veterinarian also appointed by George W. Bush. His term is perhaps best remembered for three features: the audacity of a veterinarian making decisions about women’s health and reproduction, his vehement opposition to Plan B’s approval, and the criminal charges against him for false reporting about holdings relevant to his appointment (that he and his wife owned stocks in food, beverage, and medical device companies that he was in charge of regulating). He got off with probation and a fine.

Susan F. Wood was another casualty of Crawford’s brief and divisive tenure at the FDA. As noted, she resigned because of the politicization of the agency—specifically, having the approval of Plan B emergency contraception denied, despite scientific evidence of the pill’s safety and recommendations from the FDA’s own advisory committee.

Andrew C. von Eschenbach (commissioner, 2005–2009) had been the head of the National Cancer Institute before being appointed as FDA commissioner. He was also tied to the decision of the FDA to deny emergency contraceptives over-the-counter status, despite the recommendation of the FDA’s advisory group and its own staff members, as well as that of many medical organizations.17 The FDA had followed advisory committee recommendations in every other case in the past decade. He is also known for reportedly threatening FDA reviewers who disagreed with him. Von Eschenbach’s ideologic, rather than evidence- based, decisions were so egregious that on March 23, 2009, the U.S. District Court (Tummino v. Torti) ordered the FDA to reconsider its decision blocking access to Plan B. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The court’s conclusions about the FDA’s behavior were damning.

The FDA’s ability to function and its reputation have been seriously hurt in the past decade. In a 2006 survey of FDA scientists, about 18 percent responded that they had been asked to exclude or alter information or their report’s conclusions for nonscientific reasons. A further 60 percent were aware of cases where industry “inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” One-fifth (20 percent) said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” Lest you think this survey was markedly biased, even Senator Chuck Grassley, a staunch Republican, commented on the survey report, “The responses of these scientists reinforce the findings of the independent Government Accountability Office, which said the process for reviewing drugs on the market is deeply flawed.”

As a result of the politicization, the FDA staff has reportedly become greatly demoralized, interfering with its ability to function and protect the public. FDA whistle-blowers have testified that the agency considers the drug companies its clients, and its decision-making furthers the interests of those clients.

Many experienced and valuable clinicians have left the agency, leaving a void. Equally importantly, the FDA has lost considerable respect and authority in the eyes of both the public and important members of Congress.

From 2001 to 2009, the most obvious politicization at the FDA was related to women’s health issues, and especially access to contraception.

In March 2009, President Obama issued a memorandum on scientific integrity. A further encouraging sign of change was the May 2009 appointment of two well-respected physicians to lead the FDA, Drs. Margaret Hamburg and Joshua Sharfstein. Dr. Sharfstein has since left. Dr. Hamburg, the opening speaker at the UCS conference, noted that it was imperative to build trust in FDA’s integrity, and that it is science-based. Dr. Hamburg concluded that “I agree with the Center [for Drug Evaluation and Research (CDER)] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Unfortunately, Dr. Hamburg—and all women—just had the rug pulled out from them by Sebelius’ overtly political, evidence-be-damned stance.

Plan B Perspective

The irrational decision to overrule the recommendation of numerous experts appears based on the idea that young girls would be buying the pill without parental consent, and that such girls could not do so safely. They ignore that kids can readily buy Tylenol, which has significant liver toxicity and is often a component of deadly drug overdoses. Plan B is far safer—and also unlikely to be used routinely because, at ~$50, it is relatively expensive.

Even the conservative American Academy of Pediatrics urged approval of the morning-after pill for young teens, recognizing Plan B as being a safer alternative to abortions or unwanted pregnancies.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. In contrast, mifepristone, or RU-486, is used to induce a medical abortion in a process similar to a miscarriage.

What were the arguments against Plan B this time? President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. His personal preferences are not “evidence-based science”. And he is deluding himself. We can guide our children, but we cannot control their behavior. My hope has been to educate my kids and offer them counsel knowing that, for better or worse, they will make many mistakes along the way. Prevention of pregnancy through ready access to contraceptives is far safer than an abortion or unwanted pregnancy. . .which may doom a teen to a lifetime of poverty and misery. There is a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

Even the digital world seems to be biased, as now even Siri is getting into the act. Siri conveniently can direct you where to buy Viagra, but feigns ignorance when asked to direct to a reproductive health center offering abortion counseling or services.

The Plan B Decision has been characterized as “Sacrificing ‘Change We Can Believe In’ for Expediency?” “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty.” The Ft. Wayne paper has it right stating, “Plan B politics ignore human toll.” I have never understood how many conservatives can demand censorship, restriction of contraceptives, and control of women’s bodies, all in the name of being “pro-life.” Fetal rights trump a woman’s…but then these people take no responsibility for the care, feeding, and education of these unwanted children. The sanctity of life ends at the womb. A life sentence is a huge price for a moment’s mistake.

Mechai Viravaidya

Even Thailand, which many US citizens likely would (erroneously) consider to be a third-world country, is more enlightened in some health-related ways. For example, Mechai Viravaidya, a former Thai senator and founder of the Population and Community Development Association (PDA), and enormously successful family planning NGO, made a brilliant educational campaign focused on reducing both the birthrate and the AIDS epidemic, by making sex education fun and promoting condoms to be as readily available as cabbages. He even has a restaurant and resort known as “Cabbages and Condoms.” It was a wonderful place to visit. (insert pic)

So why did Obama and Sebelius kill OTC Plan B—the first time that the Health and Human Services Commission has ever overruled the FDA? Only two reasons come to mind. The first is that Obama is overtly campaigning for the conservative vote. The second is similar, but a bit less overt—that OTC Plan B was sacrificed to take a firmer stance on having contraceptive coverage as part of all insurance plans.

And Plan B’s got it right, too, in their ad: “I chose a condom but it broke. Now I Have A Second Chance.”

Why don’t the politicians get it?

~~~

Images: Morning After The Morning’s Trash, from waltarrrrr on Flickr; pictures of condom bouqets and t-shirt by the author; Mechai Viravaidya holding a t-shirt, from Gates Foundation on Flickr;

Previously in this series:

Molecules to Medicine: Clinical Trials for Beginners
Molecules to Medicine: From Test-Tube to Medicine Chest
Lilly’s Shocker, or the Post-Marketing Blues
Molecules to Medicine: Pharma Trumps HIPAA?
Molecules to Medicine: Should pepper spray be put on (clinical) trial?
Molecules to Medicine: FDA at a Crossroads—a Tough Place to Be

Link:
Molecules to Medicine: Plan B: The Tradition of Politics at the FDA

Uncategorized Comments Off on Molecules to Medicine: Plan B: The Tradition of Politics at the FDA | February 3rd, 2012

STAMFORD -- Justin Wexler, 12, a seventh-grader at Scofield Magnet Middle School, is asking Stamford residents to "be a super hero on Super Bowl Sunday" by registering to be a bone marrow donor.

Justin is hosting a donor drive at the Jewish Community Center, at 1035 Newfield Ave., from 10 a.m. to 2 p.m. on Sunday for his mitzvah project, a contribution to the community before his bar mitzvah.

"Don't worry, there's plenty of time to do this early in the day and get back home in time to watch the game," said Justin, who will be rooting for the Giants on Sunday.

The donor drive will take about 6 minutes for each participant from start to finish, he explained, calmly spelling out the detailed process step-by-step as he sat at the head of his family's dining room table Tuesday afternoon, his bright blue eyes shining.

"You walk into the JCC, and first you'll come to a station and they'll tell you the eligibility requirements ¦ then you fill out a basic registration form and go off to the swabbing station," he said. Each donor will then take a swab from the inside of their left and right cheek and wrap their samples up with their information.

"That's it. It doesn't take long," he said. "But think about what could come from it."

Justin came up with the idea for a bone marrow drive around Thanksgiving, as he and his mother reflected on his father's experiences as a bone marrow donor for a woman in Long Island about two years ago. Justin's grandfather also donated bone marrow before Justin was born. The idea that his family members were able to save others' lives so easily stuck with him.

There are nearly 3 million potential donors registered with DKMS, the bone marrow donor center through which Justin will run his drive. But with a new diagnosis every four minutes, the donor reserves still aren't enough; 60 percent of bone cancer patients never receive the transplants they need.

"It's like finding a needle in a haystack," Justin said. His hope is that his drive will add 180 new names to that registry, and that someone will someday be a match for someone else in need. He chose the number 180 because it is a multiple of 18, a spiritual number in the Jewish faith that has strong ties to "life."

"It's mitzvah, and trying to give someone else a life, so we thought 180 would be a good goal," he said.

While Justin said he is hoping to sign up scores of potential donors, he stressed that people should not register if they're not absolutely certain they will be willing to go through with the transplant. He mentioned a boy around his age in Texas that he met around the holidays, who recently found a non-related donor for his second transplant after a transplant from his brother did not work as well as he and his doctors had anticipated.

"Imagine if they found him a match and then they said no," Justin said.

There are two ways to donate if a match is found. About 80 percent of the time, a donor's blood is removed from one arm with a needle, blood stem cells are filtered out and the remaining blood is pumped back into the other arm. In the other method, marrow cells are collected from a donor using a special syringe.

The first option can often take two days, while the second takes about one or two hours in outpatient surgery. While flu-like side effects can occur for about 48 hours after the first option, donors usually experience some pain, bruising and stiffness for up to two weeks after the second option, according to DKMS.

"I think most people when they find out someone has cancer, they feel helpless, but this could be an opportunity to save someone's life," said Justin's mother, Robin Wexler.

Justin's not old enough to swab his own cheeks for the cause -- donors have to be between the ages of 18 and 55 -- but he said he is glad to be helping by spreading the word.

"Maybe someone will show up on Sunday, someone who's never even thought about doing this before, and maybe that person will be a match; maybe they'll save a life," he said. "Imagine that."

Staff writer Maggie Gordon can be reached at maggie.gordon@scni.com or 203-964-2229.

View original post here:
Stamford boy hosting bone marrow donor drive Sunday

Bone Marrow Stem Cells Comments Off on Stamford boy hosting bone marrow donor drive Sunday | February 3rd, 2012

NEW YORK, Jan. 30, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Biobanking for Medicine: Technology and Market 2012-2022

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Report Details

What does the future hold for biobanks? Visiongain's report shows you potential revenues and trends to 2022. Find data, forecasts and discussions for biobanking in medicine.

Discover sales predictions at overall market, submarket and national levels to 2022. Our study gives you business research, analysis and opinion for applications in medical research, pharmaceuticals and diagnostics. 

How will the biobanking industry perform? Receive forecasts for human tissue banking, stem cell banking, private cord banking, other services (e.g., DNA and RNA storage), commercial biobanks, academic collections and other operations. You find revenues and discussions.

R&D applications are multiplying and widening. Assess contributions of biobanks in understanding disease, drug discovery, drug development and biomarkers. This decade will result in technological and organisational progress, public and private, benefiting healthcare. 

Our report discusses Cryo-Cell International, Cord Blood America, Tissue Solutions, Asterand, ViaCord, LifebankUSA, China Cord Blood and other organisations. See activities and outlooks. 

Biobanks and biorepositories will become more important to medical R&D and human healthcare. Biological science and technology stand to benefit. Discover the prospects. 

Visiongain's study provides data, analysis and opinion aiming to help your research, calculations, meetings and presentations. You can find answers now in our work.

Revenue forecasts, market shares, developmental trends, discussions and interviews

In the report you find revenue forecasting, growth rates, market shares, qualitative analyses (incl. SWOT and STEP), news and views. You receive 72 tables and charts and six research interviews.

Advantages of Biobanking for Medicine: Technology and Market 2012-2022 for your work

In particular, this study gives you the following knowledge and benefits:• Find revenue predictions to 2022 for the overall world market and submarkets, seeing growth trends• Assess companies in medical biobanking, discovering activities and outlooks• See revenue forecasts to 2022 in leading countries for human tissue banking - US, Japan, Germany,France, UK, Spain, Italy, China and India• Review developmental trends for biobanks - technologies and services• Investigate competition and opportunities influencing commercial results• Find out what will stimulate and restrain that industry and market• View expert opinions from our survey of that biotechnology sector.

There, you receive a distinctive mix of quantitative and qualitative work with independent predictions. We analyse developments and prospects, helping you to stay ahead.

Gain business research, data and analysis for medical biobanking Our study is for everybody needing industry and market analyses for medical biobanks. Find data, trends and answers. Avoid missing out - please order our report now.

Visiongain is a trading partner with the US Federal GovernmentCCR Ref number: KD4R6 

Table of Contents1. Executive Summary

1.1 Summary Points of this Report

1.2 Aims, Scope and Format of the Report

1.2.1 Speculative Aspects of Assessing the Biobanking Market

1.2.2 Chapter Outlines

1.3 Research and Analysis Methods

1.3.1 Human Tissue Banking Market

1.3.2 Stem Cell Banking Market

2. Introduction to Biobanking2.1 Biobanking2.1.1 Processes Involved in Biobanking2.2 Biobanks: A Two-Fold Character2.3 Key Features2.4 Classification of Biobanks2.4.1 Volunteer Groups2.4.1.1 Population-Based Biobanks2.4.1.2 Disease-Oriented Biobanks2.4.2 Ownership or Funding Structure2.5 Guidelines and Standards2.5.1 Guidelines for Biobanks and Use of Biological Samples for Research2.5.2 Industry Standards for Biobanks2.5.3 Biobanking Processes Governed by Guidelines2.6 Laws and Regulations for Biobank-Based Research

3. Biobanking and the Pharmaceutical Industry

3.1 Scientific and Commercial Use of Biobanking in the Pharmaceutical Industry

3.1.1 Research and Drug Development

3.1.1.1 Understanding Disease Pathways

3.1.1.2 Drug Discovery

3.1.1.3 Biomarker Discovery

3.1.2 Therapeutics

3.1.3 Clinical Trials

3.2 Biobanks Operated by Pharmaceutical Companies

4. Biobanking Associated Market: Systems, Software, Consumables and Services Associated with Biobanking4.1 Overview4.2 Systems/Technologies4.2.1 Automated Liquid Handling4.2.1.1 Frozen Aliquotting: New Technology in Development4.2.2 Storage4.2.2.1 Ultra-Low Temperature Freezing4.2.2.2 Room-Temperature Storage4.2.3 RFID and Tagging Technologies4.3 Software4.3.1 Laboratory Information Management System (LIMS)4.3.1.1 LIMS Functions4.4 Consumables4.5 Services

5. The World Medical Biobanking Market to 2022

5.1 Current State of the Biobanking Market

5.2 Geographical Footprint

5.3 Growing Demand for Biobank Resources

5.4 Revenue Forecast for Overall Market

5.4.1 Scope and Limitations

5.4.2 Biobanking Market, 2011-2022

5.4.2.1 Sales Forecasts for Biobanking Market, 2011-2016

5.4.2.2 Sales Forecasts for Biobanking Market, 2017-2022

5.5 Commercial Biobanks: New Resources for Research

6. Human Tissue Banking Market6.1 Revenue Forecast for Overall Human Tissue Banking Market, 2011-20226.1.1 Revenue Forecast for Overall Human Tissue Banking Market, 2011-20166.1.2 Revenue Forecast for Overall Human Tissue Banking Market, 2017-20226.2 Revenue Forecasts for Human Tissue Banking Market by Type of Biobank, 2011-20226.2.1 Revenue Forecast for Commercial Human Tissue Banking Market, 2011-20166.2.2 Revenue Forecast for Commercial Human Tissue Banking Market, 2017-20226.2.3 Revenue Forecast for Academic & Other Human Tissue Banking Market, 2011-20166.2.4 Revenue Forecast for Academic & Other Human Tissue Banking Market, 2017-20226.3 Revenue Forecasts for Human Tissue Banking in Leading National Markets, 2011-20226.4 Some Commercial Participants in the Human Tissue Banking Market6.4.1 Business Models of Companies in the Biobanking Market6.4.2 Tissue Solutions6.4.2.1 Overview6.4.2.2 Global Presence6.4.2.3 Products and Services6.4.2.3.1 Banked Samples6.4.2.3.2 Prospective Samples6.4.2.3.3 Fresh Samples6.4.2.3.4 Freshly Isolated and Primary Cells6.4.2.3.5 Services6.4.2.4 Strengths and Capabilities6.4.2.5 Future Outlook6.4.3 Asterand6.4.3.1 Overview6.4.3.2 Global Presence6.4.3.3 Products and Services6.4.3.3.1 XpressBANK6.4.3.3.2 ProCURE6.4.3.3.3 PhaseZERO6.4.3.3.4 BioMAP6.4.3.4 Asterand: Raised Barriers for New Market Entrants?6.4.3.5 Financial Performance6.4.3.6 Future Outlook

7. Stem Cell Banking

7.1 Overview

7.2 Revenue Forecast for Overall Stem Cell Banking Market, 2011-2022

7.2.1 Revenue Forecast for Stem Cell Banking Market, 2011-2016

7.2.2 Revenue Forecast for Stem Cell Banking Market, 2017-2022

7.3 Stem Cell Banks for Research: High Growth Possible

7.4 Umbilical Cord Blood Banking for Stem Cells

7.4.1 Blood Banks: Private vs. Public

7.4.2 Biological Insurance: Private Blood Banking

7.4.3 Umbilical Cord Banking: The Controversies

7.4.3.1 US Oversight of Cord Blood Stem Cells

7.4.4 Revenue Forecast for Private Cord Blood Banking Market, 2011-2016

7.4.5 Revenue Forecast for Private Cord Blood Banking Market, 2017-2022

7.4.6 Companies in the Field

7.4.6.1 Cord Blood America: Looking Towards the Chinese Market

7.4.6.2 ViaCord: 145,000 Blood Units in Storage

7.4.6.3 Cryo-Cell International: The First Cord Blood Bank

7.4.6.4 Stem Cell Authority: Exclusive Stem Cells

7.4.6.5 LifebankUSA: Placenta-Cord Banking

7.4.6.6 Biogenea-Cellgenea

7.4.6.7 China Cord Blood Corp

7.4.6.8 Cryo-Save

7.4.6.9 Thermogenesis

7.5 Gene/DNA Banking

8. Industry Trends8.1 Automated Biobanking8.1.1 Increased Uptake of Laboratory Information Management Systems (LIMS) in Biobanking8.1.2 Addressing Sample Storage and Tracking Issues8.2 Green Banking8.3 Creation of National Biobanks8.4 HIPAA Amendments

9. Qualitative Analysis of the Biobanking Sector

9.1 Strengths

9.1.1 Wealth of Information for Genetic Research

9.1.2 Potential to Change Treatments

9.1.3 Many Governments Support Biobanking

9.2 Weaknesses

9.2.1 Quality Concerns for Some Existing Biospecimen Collections

9.2.2 Lack of Standardisation and Harmonisation of Best Practices

9.2.3 Limited Sharing and Linkage of Biobanks

9.3 Opportunities

9.3.1 Genome-Wide Association Studies (GWAS)

9.3.2 Personalised Medicine

9.3.3 Pharmacogenomics: Driving the Personalised Medicine Approach

9.4 Threats

9.4.1 Ethical and Regulatory Issues

9.4.1.1 Limitations of Informed Consent in Biobanking

9.4.1.2 Confidentiality and Security to Prevent Improper Use

9.4.2 Social and Cultural Issues

9.4.3 Ownership Issues

9.4.4 Funding

10. Research Interviews from Our Survey10.1 Dr Morag McFarlane, Chief Scientific Officer, Tissue Solutions10.1.1 On the Use of Biobank Samples in the Pharmaceutical Industry 10.1.2 On Commercial Aspects of Biobanking10.1.3 On the Business of Tissue Solutions10.1.4 On the Attractiveness of Human Tissue Banking10.1.5 On the Future of the Biobanking Market10.2 Dr Angel García Martín, Director, Inbiomed10.2.1 On the Importance of Biobanking in the Pharmaceutical Industry 10.2.2 On the Use of Technology in Biobanking 10.2.3 On Increased Recognition of Biobanking and Harmonisation of Samples 10.2.4 On the Use of Biobanks by the Pharmaceutical Industry 10.2.5 On Private Biobanks and Scale of Operations 10.2.6 On Commercial and Public Biobanking and Legislation 10.2.7 On the Most Attractive Segment in Commercial Biobanking10.2.8 On the Future of Biobanking: Drivers and Challenges10.3 Dr Piet Smet, Director, Business Development, BioStorage Technologies10.3.1 On Defining Biorepositories and Biobanks10.3.2 On the Services of Biostorage10.3.3 On Main Customers for Biostorage10.3.4 On the Importance of Biorepositories in Research and Industry10.3.5 On Technology Use in Biobanks10.3.6 On Increased Recognition of Biobanking and Harmonisation of Samples 10.3.7 On the Use of Biobanks by the Pharmaceutical Industry 10.3.8 On Private Biobanks and Scale of Operations 10.3.9 On Commercial and Public Biobanking and Legislation 10.3.10 On the Most Attractive Segment in Commercial Biobanking10.3.11 On Biobanking in 202010.3.12 On Drivers and Challenges in the Sector10.4 Dr Tom Hoksbergen, Marketing and Sales, SampleNavigator Laboratory Automation Systems10.4.1 On the Services of SampleNavigator10.4.2 On Main Customers for SampleNavigator10.4.3 On the Importance of Biorepositories in Research and Industry10.4.4 On Technology Use in Biobanks10.4.5 On Increased Recognition of Biobanking and Harmonisation of Samples 10.4.6 On the Use of Biobanks by the Pharmaceutical Industry 10.4.7 On Commercial Biorepositories/Banks and Scale of Operations 10.4.8 On Commercial and Public Biobanking10.4.9 On the Most Attractive Segment in Commercial Biobanking10.4.10 On Biobanking in 202010.4.11 On Drivers and Challenges in the Sector10.5 Mr Rob Fannon, Clinical Operations Manager, BioServe10.5.1 On the Services of BioServe10.5.2 On Main Customers for BioServe10.5.3 On the Importance of Biorepositories in Research and Industry10.5.4 On Technology Use in Biobanks10.5.5 On Increased Recognition of Biobanking and Harmonisation of Samples 10.5.6 On the Use of Biobanks by the Pharmaceutical Industry 10.5.7 On Commercial Biorepositories/Banks and Scale of Operations 10.5.8 On Commercial and Public Biobanking10.5.9 On the Most Attractive Segment in Commercial Biobanking10.5.10 On Biobanking in 202010.5.11 On Drivers and Challenges in the Sector10.6 Dr Frans A.L. van der Horst, Chairman, Dutch Collaborative Biobank10.6.1 On Importance of Biorepositories in Research and Industry10.6.2 On Increased Recognition of Biobanking and Harmonisation of Samples 10.6.3 On the Services of Dutch Collaborative Biobank10.6.4 On Commercial Drivers for Bio-Repositories/Biobanking Market10.6.5 On Commercial and Public Biobanking10.6.6 On Sustaining/Recovering Costs10.6.7 On the Most Attractive Segment in Commercial Biobanking10.6.8 On Ethical, Legal and Social Issues in Biorepositories/Biobanks

11. Conclusions

11.1 Biobanking for Research and Therapeutics

11.2 Biobanking: The Future for Drug Discovery and Personalised Medicine

11.3 Commercial Drivers of the Biobanking Market

11.4 The Sector Has Marked Challenges, but Many Opportunities for Growth

List of TablesTable 2.1 Prominent Population-Based Biobanks, 2011

Table 2.2 Prominent Disease-Oriented Biobanks, 2011

Table 2.3 Some Guidelines and Recommendations for Biobanks, 2011

Table 2.4 Laws and Regulations for Biobank-Based Research, Consent Requirements, and Privacy/ Data Protection, 2011

Table 3.1 Some Pharmaceutical and Biotechnology Companies with In-House Biobanks, 2011

Table 4.1 Prominent Companies in the Automated Liquid Handling Market, 2011

Table 4.2 Prominent Companies in Ultra-Low Temperature Freezer Market, 2011

Table 4.3 Prominent LIMS Vendors, 2011

Table 4.4 Prominent Consumables Suppliers for Biobanking, 2011

Table 4.5 Prominent Biorepository Service Providers, 2011

Table 5.1 Estimated Number of Biobanks in Europe, 2011

Table 5.2 Biobanking Market: Grouped Revenue Forecasts, 2010-2016

Table 5.3 Biobanking Market: Grouped Revenue Forecasts, 2017-2022

Table 6.1 Human Tissue Banking Market: Overall Revenue Forecast, 2010-2016

Table 6.2 Human Tissue Banking Market: Overall Revenue Forecast, 2017-2022

Table 6.3 Human Tissue Banking Market: Revenue Forecasts by Type of Biobank, 2010-2016

Table 6.4 Human Tissue Banking Market: Revenue Forecasts by Type of Biobank, 2017-2022

Table 6.5 Human Tissue Banking Market: Revenue Forecasts for Leading National Markets, 2010-2016

Table 6.6 Human Tissue Banking Market: Revenue Forecasts for Leading National Markets, 2017-2022

Table 6.7 Some Leading Companies in the World Biobanking Market, 2011

Table 6.8 Asterand: Revenue by Segment, 2009 and 2010

Table 6.9 Asterand: Revenue by Geographical Area, 2010

Table 7.1 Stem Cell Banking Market: Overall Revenue Forecast, 2010-2016

Table 7.2 Stem Cell Banking Market: Overall Revenue Forecast, 2017-2022

Table 7.3 Prominent Stem Cell Banks Serving the Research Community, 2011

Table 7.4 Costs of Various Private Cord Blood Banks Worldwide, 2011

Table 7.5 Private Cord Blood Banking Market: Revenue Forecast, 2010-2016

Table 7.6 Private Cord Blood Banking Market: Revenue Forecast, 2017-2022

Table 7.7 Cord Blood Banking Market: Drivers and Restraints, 2012-2022

Table 7.8 Some Prominent Companies in the Cord Blood Banking Market, 2011

Table 7.9 Cryo-Cell International Revenue, 2009-2010

Table 7.10 China Cord Blood Corp Revenue and Subscribers, 2009-2010

Table 7.11 Cryo-Save Revenue and Operating Profit, 2009-2010

Table 7.12 Cryo-Save Revenue by Region, 2010

Table 9.1 SWOT Analysis of the Biobanking Market: Strengths and Weaknesses, 2012-2022

Table 9.2 SWOT Analysis of the Biobanking Market: Opportunities and Threats, 2012-2022

Table 9.3 Information for a Biobank Donor, 2011

Table 11.1 Human Tissue Biobanking Market by Country, 2010, 2016, 2019 & 2022

List of FiguresFigure 2.1 Main Processes Involved in Biobanking, 2011

Figure 2.2 Classification of Biobanks, 2011

Figure 3.1 Biobanking and Pharmaceutical Development, 2011

Figure 4.1 Biobanking, Applications and Users, 2011

Figure 4.2 Functions of LIMS, 2011

Figure 5.1 Overall Biobanking Market: Revenue Forecast, 2010-2016

Figure 5.2 Overall Biobanking Market: Revenue Forecast, 2017-2022

Figure 6.1 Human Tissue Banking Market: Overall Revenue Forecast, 2010-2016

Figure 6.2 Human Tissue Banking Market: Overall Revenue Forecast, 2017-2022

Figure 6.3 Human Tissue Banking Market: Forecast by Type of Biobank, 2010-2016

Figure 6.4 Human Tissue Banking Market: Forecast by Type of Biobank, 2017-2022

Figure 6.5 Human Tissue Banking Market: Share by Type of Biobank, 2010

Figure 6.6 Human Tissue Banking Market: Share by Type of Biobank, 2022

Figure 6.7 World and US Human Tissue Banking Markets: Revenue Forecasts, 2010-2022

Figure 6.8 Japan, EU 5 and Other Leading Human Tissue Banking Markets: National Revenue Forecasts, 2010-2022

Figure 6.9 Human Tissue Banking: National Market Shares, 2010

Figure 6.10 Human Tissue Banking: National Market Shares, 2016

Figure 6.11 Human Tissue Banking: National Market Shares, 2019

Figure 6.12 Human Tissue Banking: National Market Shares, 2022

Figure 6.13 Commercial Sourcing of Biological Samples, 2011

Figure 6.14 Commercial Banking of Biological Samples, 2011

Figure 6.15 Asterand: Revenues, 2009 & 2010

Figure 6.16 Asterand: Revenue Shares by Region of Destination, 2010

Figure 6.17 Asterand: Revenue Shares by Region of Origin, 2010

Figure 7.1 Stem Cell Banking Market: Revenue Forecast, 2010-2016

Figure 7.2 Stem Cell Banking Market: Revenue Forecast, 2017-2022

Figure 7.3 Twenty-Year Storage Costs at Various Private Cord Blood Banks Worldwide, 2011

Figure 7.4 Cord Blood Banking Market: Revenue Forecast, 2010-2016

Figure 7.5 Cord Blood Banking Market: Revenue Forecast, 2017-2022

Figure 7.6 Cryo-Cell International Revenue, 2009-2010

Figure 7.7 China Cord Blood Corp Revenue and Subscribers, 2009-2010

Figure 7.8 Cryo-Save Revenue and Operating Profit, 2009-2010

Figure 7.9 Cryo-Save Revenue Shares by Region, 2010

Figure 11.1 Biobanking Market: World Sales Forecast, 2010, 2012, 2016, 2019 & 2022 

Companies ListedAbcellute

Abgene

Adnexus Therapeutics

AFNOR Groupe

AKH Biobank

AlloSource

American National Bioethics Advisory Commission 

American Type Culture Collection

Amgen

Analytical Biological Services

ARCH Venture Partners

Asterand

AstraZeneca

Australasian Biospecimen Network (ABN)

Autoscribe

AXM Pharma 

Bayer-Schering

Beckman Coulter

Beike Biotechnology 

Biobank Ireland Trust

Biobank Japan

Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) 

BioFortis

Biogen Idec

Biogenea-CellGenea 

BioLife Solutions

Biomatrica

Biopta

BioRep

BioSeek

BioServe

BioStorage LLC

BioStorage Technologies

BrainNet Europe

Caliper LifeSciences

Canadian Partnership for Tomorrow

CARTaGENE

Cellgene Corporation

Cells4Health

Chemagen

China Cord Blood Corp

Chinese Ministry of Health

CLB/Amsterdam Medical Center

CorCell

Cord Blood America

Cord Blood Registry 

CORD:USE (US Public Cord Blood Bank) 

CordLife

Cordon Vital (CBR) 

Coriell Institute for Medical Research

Council of Europe (CoE)

Covance

Cryo Bio System

Cryo-Cell International

Cryometrix

Cryo-Save

Cureline

Cybrdi

Danubian Biobank Foundation

deCODE Genetics

Department of Health (DoH, UK)

Draper Laboratory

Duke University Medical Center

Dutch Collaborative Biobank

EGeen

Eli Lilly

Eolas Biosciences 

Estonian Genome Project

EuroBioBank

European Commission (EC)

European Health Risk Monitoring (EHRM)

European Medicines Agency (EMA/EMEA)

European Union Group on Ethics (EGE)

Fisher BioServices

Fondazione I.R.C.C.S. Istituto Neurologico C. Besta

Food and Drug Administration (US FDA)

Foundation for the National Institutes of Health 

Fundación Istituto Valenciano de Oncología

Fundeni Clinical Institute

Genentech

Generation Scotland

GeneSaver

GeneSys

Genetic Association Information Network (GAIN)

Genizon Biosciences

Genome Quebec Biobank 

GenomEUtwin

Genomic Studies of Latvian Population

GenVault

German Dementia Competence Network

GlaxoSmithKline (GSK)

H. Lee Moffitt Cancer Center and Research Institute 

Hamilton

Hopital Necker Paris - Necker DNA Bank

Human Tissue Authority (HTA)

Hungarian Biobank

HUNT, Norway

ILSBio LLC

Inbiobank

Inbiomed

Indivumed

INMEGEN

Institut National de la Santé et de la Recherche Médicale (INSERM)

Integrated BioBank of Luxembourg

International Agency for Research on Cancer (IARC)

International Air Transport Association (IATA)

International Organization for Standardization (ISO)

International Society for Biological and Environmental Repositories (ISBER)

International Stem Cell Corporation

Kaiser Permanente

KORA-gen

LabVantage Solutions

LabWare

Leiden University Medical Center

LifebankUSA

LifeGene

LifeStem

Malaysian Cohort Project

Matrical Biosciences

Matrix

Medical Research Council (MRC)

Medical University of Gdansk

Merck & Co.

Merck Sharp & Dohme Limited (MSD)

Merck-Serono

Micronic

Millennium (Takeda Oncology Company)

MVE-Chart

National Cancer Institute (NCI)

National DNA Bank (US)

National Human Genome Research Institute (NHGRI)

National Institute of Environmental Health

National Institutes of Health (NIH)

National Public Health Institute 

National Research Ethics Service (NRES) 

NeoCodex

NeoStem

Neuromuscular Bank of Tissues and DNA Samples

New Brunswick Scientific

NEXUS Biosystems

Northwest Regional Development Agency

Novacare Bio-Logistics

Novartis

NUgene Project

Ocimum Biosolutions

Office of Biorepositories and Biospecimen Research (OBBR)

OnCore UK

Organisation for Economic Co-operation and Development (OECD)

OriGene

Oxagen

Pacific Bio-Material Management

PathServe

Perkin Elmer

Pfizer

Pharmagene Laboratories Trustees Limited

Polaris Ventures 

Pop-Gen (University Hospital Schleswig-Holstein)

PrecisionMed

Prevention Genetics

ProMedDx

Promoting Harmonisation of Epidemiological Biobanks in Europe (PHOEBE)

ProteoGenex

Public Population Projects in Genomics (P3G Consortium)

Qiagen

RAND Corporation

Regenetech

REMP

Reproductive Genetics Institute (RGI)

Research Centre of Vascular Diseases, University of Milan

Rhode Island BioBank, Brown University

Roche

RTS Life Science

Saga Investments LLC

SampleNavigator Laboratory Automation Systems

Sanofi

SANYO Biomedical

Scottish Government

Seattle Genetics

Sejtbank (Hungarian Cord Blood Bank) 

SeqWright DNA Technology Services

SeraCare Life Sciences

Singapore Tissue Network

StarLIMS

Steelgate

Stem Cell Authority

Stem Cells for Safer Medicine (SC4SM)

Stem Cells Research Forum of India

Stemride International

Taiwan Biobank

Taizhou Biobank

TAP

Tecan

The Automation Partnership

The Sorenson Molecular Genealogy Foundation (SMGF)

Thermo Fisher Scientific

Thermogenesis

Tissue Bank Cryo Center (Bulgaria)

Tissue Solutions

Titan Pharmaceuticals

TotipotentSC

Trinity Biobank

Tumorothèque Necker-Entants Malades

UK Biobank

UK Stem Cell Bank

UmanGenomics

Umeå University

University Hospital Angers

University Medical Center Gent

University of Massachusetts Stem Cell Bank

University of Tuebingen, Department of Medical Genetics

US Biomax

Västerbotten County Council

ViaCord

Wellcome Trust

Wellcome Trust Case-Control Consortium (WTCCC)

Western Australian Genome Health Project

Wheaton Science International

Wisconsin International Stem Cell (WISC) Bank

World Health Organization (WHO)

Zhejiang Lukou Biotechnology Co 

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Biobanking for Medicine: Technology and Market 2012-2022

Uncategorized Comments Off on Biobanking for Medicine: Technology and Market 2012-2022 | February 3rd, 2012

OTTAWA , Feb. 1, 2012 /CNW/ - The following is a statement by Russell Williams , President of Canada's Research-Based Pharmaceutical Companies (Rx&D) on the announcement by the Government of Canada today to ensure that personalized medicine will allow for more effective treatments, thus supporting our Canadian health care system in a more sustainable way.

"Canada's Research-Based Pharmaceutical Companies welcome this commitment by the Government of Canada to establish personalized medicine as the way to transform the delivery of health care to patients.

"At Rx&D, we believe that providing the right medicine with the right dose to the right patient at the right time is crucial to improving health outcomes for Canadians. With the rise of chronic disease and an aging population, all governments are grappling with unprecedented demand for health care services. It is clear that we face a collective challenge to sustain and improve our health care system where traditional approaches are no longer efficient.

"We commend the Government of Canada's commitment to engage in this work. Pharmaceutical innovation is a proven tool to help Canadians live longer, healthier, more productive lives. It is critical to the future productivity of our country, our workplaces, our communities and our citizens. Innovation is essential for "patient-centered" care.

"The development of new and more effective medicines and vaccines continues to change the face of health care in Canada . Canadians now survive life threatening illnesses and live with chronic conditions in ways not possible for previous generations.

"We applaud the Canadian Institutes of Health Research, Genome Canada and the Cancer Stem Cell Consortium for their vision and leadership to develop and implement a scientific innovation that will result in better health for Canadians."

About Rx&D

Rx&D is the association of leading research-based pharmaceutical companies dedicated to improving the health of Canadians through the discovery and development of new medicines and vaccines. Our community represents 15,000 men and women working for 50 member companies and invests more than $1 billion in research and development each year to fuel Canada's knowledge-based economy. Guided by our Code of Ethical Practices, our membership is committed to working in partnership with governments, healthcare professionals and stakeholders in a highly ethical manner.

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Statement - Rx&D Applauds Government of Canada for Investing in Personalized Medicine

Uncategorized Comments Off on Statement – Rx&D Applauds Government of Canada for Investing in Personalized Medicine | February 2nd, 2012

MINNEAPOLIS--(BUSINESS WIRE)-- Please replace the release dated January 23, 2012 with the following corrected version due to multiple revisions.

The corrected release reads:

LEADING GLOBAL CELL THERAPY ORGANIZATIONS SUPPORT U.S. DEPARTMENT OF JUSTICE APPEAL OF RULING ON DONOR COMPENSATION

Coalition says PBSC donor compensation poses health risks to patients and donors

A coalition of eight leading international health organizations today issued a statement supporting the U.S. Department of Justice’s appeal of the Ninth Circuit Court ruling that allows certain marrow donors to be compensated. Filed Jan. 17, the Justice Department’s appeal cites the potential for serious health risks to patients and donors if the ruling stands.

Approximately 5,000 patients each year in the United States receive marrow transplants from unrelated donors to treat leukemia, lymphoma and a number of other diseases. The marrow is a source of stem cells that are critical to restoring the immune system for these patients. Two techniques are used to extract these stem cells. The first draws marrow directly from the donor’s hip bone and the second moves the stem cells out of the bone marrow and into the bloodstream using a stimulating hormone, and then collects peripheral blood stem cells (PBSCs) in a procedure similar to the collection of platelets from blood donors.

Since 1984, the National Organ Transplant Act (NOTA) has banned payment for all marrow stem cell donations. However, a Dec. 1, 2011, Ninth Circuit Court of Appeals ruling legalized compensation for PBSC donations, but upheld the ban on compensation for marrow donation through aspiration.

“The world’s leading cell therapy organizations oppose compensating people who sell their stem cells, however collected, and believe the Ninth Circuit made an erroneous distinction between marrow stem cells extracted directly from bone or from blood,” said Jeffrey W. Chell, M.D., chief executive officer of the National Marrow Donor Program® (NMDP), a coalition member that operates the Be The Match Registry®, the world’s largest listing of volunteer marrow donors. “We fully support the Justice Department’s decision to protect patients and their donors by challenging the ruling. Those motivated by self-gain are more likely to withhold health information that would make them unsafe donors. The blood banking experience in the United States shows that this results in donations that are unacceptable from a clinical standpoint.”

The coalition includes the nonprofit NMDP, the World Marrow Donor Association, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society of Histocompatibility and Immunogenetics, International Society of Cellular Therapy and The Transplantation Society. Those seeking to overturn the ban against selling stem cells argue that payment for donors might increase patients’ access to bone marrow; however, the coalition asserts the opposite is true.

Paying for stem cells also would mean the U.S. no longer follows standards recognized throughout developed countries in Europe and Asia, which use volunteer donors in cell therapies. As a result, patients may not be able to use the worldwide search process. These international partnerships are vital to helping increase patients’ access to potential donors. In 2011, nearly half of the transplants facilitated by the NMDP involved either an international donor or patient.

The coalition cites the following reasons in its position against donor compensation:

Protecting Recipient and Donor Safety
A complete and truthful health history is critical to ensure that individuals are eligible to donate and that donated cells are free from infectious diseases. There is substantial scientific evidence that people wanting to sell their blood or body parts are more likely to withhold medical details and information that could harm patients. Ensuring Physicians’ Ability to Provide Quality Care
The decision of whether the donation occurs through the traditional method of bone marrow extraction or PBSC donation should be based on the best clinical judgment of the patient’s physician and will vary from patient to patient. While the donor always has the last say on whether and how to donate, PBSCs may not be in the best interests of the patient in many cases. Paying for PBSCs may cause donors to choose this method instead of a marrow extraction recommended by the recipient’s physician. Maintaining Altruistic Motivations
Compensating donors could deter those who are willing to donate for purely altruistic reasons. The more than 9.5 million members of the Be The Match Registry, as well as an additional 9 million potential donors available on international registries, are proof positive that people do not need financial incentive to save a life. Avoiding the Creation of Markets in Marrow Donation
Patients may promote donor drives with the promise of compensation, appealing to those with financial need, and not fully disclose the risks associated with the donation. For profit organizations also have an incentive to exploit their donors over a patient’s unique needs. In addition, markets put physicians in the morally dubious position of carrying out medical procedures solely for monetary profit.

For these reasons, the members of the coalition remain opposed to the selling of stem cells.

About the Coalition
The coalition includes the NMDP, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society for Histocompatibility and Immunogenetics, International Society of Cellular Therapy, The Transplantation Society, and the World Marrow Donor Association.

About the National Marrow Donor Program®(NMDP)
The National Marrow Donor Program (NMDP) is the global leader in providing marrow and umbilical cord blood transplants to patients with leukemia, lymphoma and other diseases. The nonprofit organization matches patients with donors, educates health care professionals and conducts research so more lives can be saved. The NMDP also operates Be The Match®, which provides support for patients, and enlists others in the community to join the Be The Match Registry® – the world’s largest listing of potential marrow donors and donated cord blood units – contribute financially and volunteer. For more information, visit marrow.org or call 1 (800) MARROW-2.

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CORRECTING and REPLACING Leading Global Cell Therapy Organizations Support U.S. Department of Justice Appeal of Ruling ...

Uncategorized Comments Off on CORRECTING and REPLACING Leading Global Cell Therapy Organizations Support U.S. Department of Justice Appeal of Ruling … | February 2nd, 2012

2 February 2012 Last updated at 08:31 ET

More than 100 police officers in Cornwall have signed up to become bone marrow donors.

Insp Dave Meredith, of Devon and Cornwall Police, had appealed to staff to register for the medical procedure.

So far, 110 officers in Cornwall have signed up to the register in three weeks, with a call to Devon officers due to follow.

Insp Meridith said: "I'm very impressed but I think this reflects on the goodwill of the officers and staff."

'Saving someone's life'

Insp Meredith said he decided to encourage registration after the donation method changed.

Continue reading the main story “Start Quote

The bigger the pool, the bigger the chance”

End Quote Karen Archer Anthony Nolan charity

Donors register by providing a sample of saliva, and then 80% of those asked to donate, do so by giving blood, from which their stem cells are retrieved.

Insp Meredith said: "In light of those changes I thought I've really got to take one step forward.

"People were a little apprehensive at first but once they thought about it and realised the implication and that they were potentially saving someone's life they readily agreed."

Simon Wilcock, an officer in Newquay who had Hodgkin's Lymphoma ten years ago, said: "I was on chemotherapy at the time and it had worked to a point.

"But it had got to the stage where without a transplant there's no doubt that in a few months I probably wouldn't have survived."

The appeal to the force was issued three weeks ago with the volunteers required to be aged between 18 and 40, although those on the register remain on it until they turn 60.

Karen Archer from the charity, Anthony Nolan, said: "It takes one person to save a life so if we've got 110 people joining the register then that's amazing news.

"People can be waiting years for that one right person to join the register, but there are 1000s of people waiting at any one time.

"The bigger the pool, the bigger the chance."

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Police officers offer bone marrow

Bone Marrow Stem Cells Comments Off on Police officers offer bone marrow | February 2nd, 2012

31-01-2012 18:50 http://www.singularityweblog.com This morning I interviewed Daniel Kraft for Singularity 1 on 1. I met Dr. Kraft at Singularity University where he is the Medicine and Neuroscience Chair and executive director of the FutureMed Program. Daniel is one of those people with an incredibly diverse spectrum of talents and interests for he is not only a medical doctor and oncologist but also an inventor, a technology and space enthusiast, an entrepreneur and an F-16 flight surgeon. During our conversation we discuss a variety of topics such as: Daniel's early interest and talent in technology and science; his original fascination with the Apollo Space program and eventual participation in International Space University; his passion for flying and being a pilot; his medical education and personal journey to becoming a faculty member at Singularity University; his desire to be an instigator, connector and motivator of innovation; the story behind as well as the purpose and structure of the FutureMed program; bone marrow harvesting, regenerative medicine and stem cell research; longevity and the future of medicine and health care; his greatest inspiration and concerns about the field of medicine and his belief that one doesn't have to be a doctor to improve health care.

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Daniel Kraft on Singularity 1 on 1 (part 1) - Video

Uncategorized Comments Off on Daniel Kraft on Singularity 1 on 1 (part 1) – Video | February 2nd, 2012

31-01-2012 20:35 http://www.singularityweblog.com This morning I interviewed Daniel Kraft for Singularity 1 on 1. I met Dr. Kraft at Singularity University where he is the Medicine and Neuroscience Chair and executive director of the FutureMed Program. Daniel is one of those people with an incredibly diverse spectrum of talents and interests for he is not only a medical doctor and oncologist but also an inventor, a technology and space enthusiast, an entrepreneur and an F-16 flight surgeon. During our conversation we discuss a variety of topics such as: Daniel's early interest and talent in technology and science; his original fascination with the Apollo Space program and eventual participation in International Space University; his passion for flying and being a pilot; his medical education and personal journey to becoming a faculty member at Singularity University; his desire to be an instigator, connector and motivator of innovation; the story behind as well as the purpose and structure of the FutureMed program; bone marrow harvesting, regenerative medicine and stem cell research; longevity and the future of medicine and health care; his greatest inspiration and concerns about the field of medicine and his belief that one doesn't have to be a doctor to improve health care.

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Daniel Kraft on Singularity 1 on 1 (part 3) - Video

Uncategorized Comments Off on Daniel Kraft on Singularity 1 on 1 (part 3) – Video | February 2nd, 2012

01-02-2012 14:59 Sridhar Ramaswamy, MD, Massachusetts General Hospital Cancer Center, Assistant Professor of Medicine, Harvard Medical School, Harvard Stem Cell Institute, discusses targeting dormant cancer cells and the possible role that they play in the development of drug resistance. Dormant cells appear in most patients with tumors. These cells are not rapidly proliferating and remain largely inactive. While these cells sleep, they are highly resistant to most types of therapy. Dormant cancer cells are intrinsically intriguing because the number of inherent mutations would denote that the cells should be rapidly proliferating. The mechanism that allows them to switch between dormant and active is yet unknown. The goal of the research is to discover the underlying cause of the dormancy, tumor progression, and the mechanism of resistance to various types of therapy.

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Dr. Ramaswamy on Targeting Dormant Cancer Cells - Video

Uncategorized Comments Off on Dr. Ramaswamy on Targeting Dormant Cancer Cells – Video | February 2nd, 2012

The Hindu Shinya Yamanaka, Centre for iPS Cell Research and Application, Japan delivering a lecture in Chennai on Thursday. Photo: V. Ganesan

Many more diseases can be targeted, says expert

While applications of induced pluripotent stem cells in stem cell therapy may be limited to a few diseases, its applications in drug discovery are wide-ranging, and many more diseases can be targeted, Shinya Yamanaka, Director, Centre for iPS Cell Research and Application, Japan, has said.

The Japanese scientist, whose breakthrough was the creation of embryonic-like stem cells from adult skin cells, believes that the best chance for stem cell therapy lies in offering hope to those suffering from a few conditions, among them, macular disease, Type 1 Diabetes, and spinal cord injuries.

On the other hand, there were multiple possibilities with drug discovery for a range of diseases, and Prof. Yamanaka was hopeful that more scientists would continue to use iPS for studying this potential.

He currently serves as the Director of the Center for iPS Cell Research and Application and as Professor at the Institute for Frontier Medical Sciences at Kyoto University. He is also a Senior Investigator at the University of California, San Francisco (UCSF) - affiliated J. David Gladstone Institutes.

An invited speaker of the CellPress-TNQ India Distinguished Lectureship Series, co-sponsored by Cell Press and TNQ Books and Journals, Prof. Yamanaka spoke to a Chennai audience on Tuesday evening about those “immortal” cells, that he originally thought would take “forever” to create, but actually took only six years.

“My fixed vision for my research team was to re-programme adult cells to function like embryonic-like stem cells. I knew it could be done, but just didn't know how to do it,” Prof. Yamanaka said.

Embryonic stem cells are important because they are pluripotent, or possess the ability to differentiate into any other type of cell, and are capable of rapid proliferation. However, despite the immense possibilities of that, embryonic cells are a mixed blessing: there are issues with post-transplant rejection (since they cannot be used from a patient's own cells), and many countries of the world do not allow the use of human embryos.

Dr. Yamanaka's solution would scale these challenges if only he and his team could find a way to endow non-embryonic cells with those two key characteristics of embryonic stem cells.

In 2006, he and his team of young researchers — Yoshimi Tokuzawa, Kazutoshi Takahashi and Tomoko Ishisaka — were able to show that by introducing four factors into mouse skin cells, it was possible to generate ES-like mouse cells. The next year, they followed up that achievement, replicating the same strategy and converted human skin cells into iPS cells. “All we need is a small sample of skin (2-3millimetres) from the patient. This will be used to generate skin fibroblasts, and adding the factors, they can be converted to iPS cells. These cells can make any type of cell, including beating cardiac myocytes (heart cells), Prof.Yamanaka explained.

iPS cells hold out for humanity a lot of hope in curing diseases that have a single cell cause. Prominent among them are Lou Gehrig's Disease or Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease. Motor neurons degenerate and die, and no effective treatment exists thus far. One reason is that there have not been good disease models for ALS in humans. It is difficult to get motor neuron from human patients and motor neurons cannot divide.

“Now, iPS cells can proliferate and can be differentiated to make motor neurons in large numbers,” he explained. Already a scientist in Japan has clarified motor neuron cells from iPS. “We are hoping that in the near future we would be able to evolve drug candidates that will be useful for ALS patients.” Treatment of spinal cord injuries using iPS cells has showed good results in mice and monkey specimens, and it is likely that in two or three years, scientists will be ready to start treatment for humans.

Toxicology, or drug side effects, is another area where iPS cells can be of use. Testing drug candidates directly on patients can be extremely dangerous. However, iPS cells can be differentiated into the requisite cell type, and the drugs tested on them for reactions. And yet, as wonderful as they may seem, iPS cells do have drawbacks, and there are multiple challenges to be faced before the technology can be applied to medicine. Are they equivalent and indistinguishable from ES cells? For a technology that has been around for only five years, the questions remain about safety. Also to derive patient-specific iPS cells, the process is time, and money-consuming, Prof. Yamanaka pointed out.

There are however, solutions in the offing, for the man who made the world's jaw drop with his discovery. One would be to create an iPS cell bank, where iPS cells could be created in advance from healthy volunteers donating peripheral blood, and skin fibroblasts, apart from frozen cord blood. The process of setting a rigorous quality control mechanism to select the best and safest iPS clones is on and would be complete within a year or two. “Many scientists are studying iPS cells across the world, and I'm optimistic that because of these efforts, we can overcome the challenges of iPS, and contribute to newer treatments for intractable diseases,” Prof. Yamanaka said.

N. Ram, Director, Kasturi & Sons Limited, introduced the speaker. Mariam Ram, managing director, TNQ India; and Emilie Marcus, executive editor, Cell Press, spoke.

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“Wide-ranging applications for pluripotent stem cells”

IPS Cell Therapy Comments Off on “Wide-ranging applications for pluripotent stem cells” | February 2nd, 2012

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a leading developer of adult stem cell technologies and therapeutics, announced today that the prestigious Experimental Neurology Journal, published an article indicating that preclinical studies using cells that underwent treatment with Brainstorm’s NurOwn™ technology show promise in an animal model of Huntington’s disease. The article was published by leading scientists including Professor Melamed and Professor Offen of the Tel Aviv University.

In these studies, bone marrow derived mesenchymal stem cells secreting neurotrophic factors (MSC-NTF), from patients with Huntington’s disease, were transplanted into the animal model of this disease and showed therapeutic improvement.

“The findings from this study demonstrate that stem cells derived from patients with a neurodegenerative disease, which are processed using BrainStorm’s NurOwn™ technology, may alleviate neurotoxic signs, in a similar way to cells derived from healthy donors. This is an important development for the company, as it confirms that autologous transplantation may be beneficial for such additional therapeutic indications,” said Dr. Adrian Harel, BrainStorm’s CEO.

"These findings provide support once again that BrainStorm’s MSC-NTF secreting cells have the potential to become a platform that in the future will provide treatment for various neuro-degenerative diseases," says Chaim Lebovits, President of BrainStorm. "This study follows previously published pre-clinical studies that demonstrated improvement in animal models of neurodegenerative diseases such as Parkinson’s, Multiple Sclerosis (MS) and neural damage such as optic nerve transection and sciatic nerve injury. Therefore, BrainStorm will consider focusing on a new indication in the near future, in addition to the ongoing Clinical Trials in ALS.”

BrainStrom is currently conducting a Phase I/II Human Clinical Trial for Amyotrophic Lateral Sclerosis (ALS) also known as Lou Gehrig’s disease at the Hadassah Medical center. Initial results from the clinical trial (which is designed mainly to test the safety of the treatment), that were announced last week, have shown that the Brainstorm’s NurOwn™ therapy is safe and does not show any significant treatment-related adverse events and have also shown certain signs of beneficial clinical effects.

To read the Article entitled ‘Mesenchymal stem cells induced to secrete neurotrophic factors attenuate quinolinic acid toxicity: A potential therapy for Huntington's disease’ by Sadan et al. please go to:

http://www.sciencedirect.com/science/article/pii/S0014488612000295

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotech company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The company, through its wholly owned subsidiary Brainstorm Cell Therapeutics Ltd., holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The technology is currently in a Phase I/II clinical trials for ALS in Israel.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements, including, inter alia, regarding safety and efficacy in its human clinical trials and thereafter; the Company's ability to progress any product candidates in pre-clinical or clinical trials; the scope, rate and progress of its pre-clinical trials and other research and development activities; the scope, rate and progress of clinical trials we commence; clinical trial results; safety and efficacy of the product even if the data from pre-clinical or clinical trials is positive; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of our proposed product candidates; dependence on the efforts of third parties; failure by us to secure and maintain relationships with collaborators; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect its technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.

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Experimental Neurology Journal: BrainStorm's NurOwn™ Stem Cell Technology Shows Promise for Treating Huntington's ...

Bone Marrow Stem Cells Comments Off on Experimental Neurology Journal: BrainStorm's NurOwn™ Stem Cell Technology Shows Promise for Treating Huntington's … | February 1st, 2012

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, Feb. 1 (HealthDay News) -- Treating stroke patients with stem cells taken from their own bone marrow appears to safely help them regain some of their lost abilities, two small new studies suggest.

Indian researchers observed mixed results in the extent of stroke patients' improvements, with one study showing marked gains in daily activities, such as feeding, dressing and movement, and the other study noting these improvements to be statistically insignificant. But patients seemed to safely tolerate the treatments in both experiments with no ill effects, study authors said.

"The results are encouraging to know but we need a larger, randomized study for more definitive conclusions," said Dr. Rohit Bhatia, a professor of neurology at the All India Institute of Medical Sciences in New Delhi, and author of one of the studies. "Many questions -- like timing of transplantation, type of cells, mode of transplantation, dosage [and] long-term safety -- need answers before it can be taken from bench to bedside."

The studies are scheduled to be presented Wednesday and Thursday at the American Stroke Association's annual meeting in New Orleans.

Stem cells -- unspecialized cells from bone marrow, umbilical cord blood or human embryos that can change into cells with specific functions -- have been explored as potential therapies for a host of diseases and conditions, including cancer and strokes.

In one of the current studies, 120 moderately affected stroke patients ranging from 18 to 75 years old were split into two groups, with half infused intravenously with stem cells harvested from their hip bones and half serving as controls. About 73 percent of the stem cell group achieved "assisted independence" after six months, compared with 61 percent of the control group, but the difference wasn't considered statistically significant.

In the other study, presented by Bhatia, 40 patients whose stroke occurred between three and 12 months prior were also split into two groups, with half receiving stem cells, which were dissolved in saline and infused over several hours. When compared to controls, stroke patients receiving stem cell therapy showed statistically significant improvements in feeding, dressing and mobility, according to the study. On functional MRI scans, the stem cell recipients also demonstrated an increase in brain activity in regions that control movement planning and motor function.

Neither study yielded adverse effects on patients, which could include tumor development.

But Dr. Matthew Fink, chief of the division of stroke and critical care neurology at New York-Presbyterian Hospital/Weill Cornell Medical Center, said that the therapy's safety is the only thing the two studies seemed to demonstrate.

"The thing to keep in mind is that these are really phase one trials," said Fink, also a professor of neurology at Weill Cornell Medical College. "I'm concerned that people get the idea that now stem cell treatment is available for stroke, and that's not the case."

Fink noted that the cells taken from study participants' hip bones can only be characterized as "bone marrow aspirates" since the authors didn't prove that actual stem cells were extracted.

"They haven't really analyzed if they're stem cells and what they turn into when they go into circulation," he added. "The best way to look at this is, it's very preliminary . . . when patients come to me to talk about it, I'm going to tell them it's years away before we know if this is going to work."

Studies presented at scientific conferences should be considered preliminary until published in a peer-reviewed medical journal.

More information

The U.S. National Institutes of Health has more information on stem cells.

Copyright © 2012 HealthDay. All rights reserved.

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Stem cell therapy shows promise for stroke

Bone Marrow Stem Cells Comments Off on Stem cell therapy shows promise for stroke | February 1st, 2012

Imaging Technology Tracks Stem Cells to Brain after Carotid Artery Injection in Animals

Newswise — Philadelphia, Pa. (February 1, 2012) – Experiments in brain-injured rats show that stem cells injected via the carotid artery travel directly to the brain, where they greatly enhance functional recovery, reports a study in the February issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The carotid artery injection technique—along with some form of in vivo optical imaging to track the stem cells after transplantation—may be part of emerging approaches to stem cell transplantation for traumatic brain injury (TBI) in humans, according to the new research, led by Dr Toshiya Osanai of Hokkaido University Graduate School of Medicine, Sapporo, Japan.

Advanced Imaging Technology Lets Researchers Track Stem Cells
The researchers evaluated a new "intra-arterial" technique of stem cell transplantation in rats. Within seven days after induced TBI, stem cells created from the rats' bone marrow were injected into the carotid artery. The goal was to deliver the stem cells directly to the brain, without having them travel through the general circulation.

Before injection, the stem cells were labeled with "quantum dots"—a biocompatible, fluorescent semiconductor created using nanotechnology. The quantum dots emit near-infrared light, with much longer wavelengths that penetrate bone and skin. This allowed the researchers to noninvasively monitor the stem cells for four weeks after transplantation.

Using this in vivo optical imaging technique, Dr Osanai and colleagues were able to see that the injected stem cells entered the brain on the "first pass," without entering the general circulation. Within three hours, the stem cells began to migrate from the smallest brain blood vessels (capillaries) into the area of brain injury.

After four weeks, rats treated with stem cells had significant recovery of motor function (movement), while untreated rats had no recovery. Examination of the treated brains confirmed that the stem cells had transformed into different types of brain cells and participated in healing of the injured brain area.

Further Progress toward Stem Cell Therapy for Brain Injury in Humans
Stem cells are likely to become an important new treatment for patients with brain injuries, including TBI and stroke. Bone marrow stem cells, like the ones used in the new study, are a promising source of donor cells. However, many questions remain about the optimal timing, dose, and route of stem cell delivery.

In the new animal experiments, stem cell transplantation was performed one week after TBI—a "clinically relevant" time, as it takes at least that long to develop stem cells from bone marrow. Injecting stem cells into the carotid artery is a relatively simple procedure that delivers the cells directly to the brain.

The experiments also add to the evidence that stem cell treatment can promote healing after TBI, with significant recovery of function. With the use of in vivo optical imaging, "The present study was the first to successfully track donor cells that were intra-arterially transplanted into the brain of living animals over four weeks," Dr Osanai and colleagues write.

Some similar form of imaging technology might be useful in monitoring the effects of stem cell transplantation in humans. However, tracking stem cells in human patients will pose challenges, as the skull and scalp are much thicker in humans than in rats. "Further studies are warranted to apply in vivo optical imaging clinically," the researchers add.

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About Neurosurgery
Neurosurgery, the Official Journal of the Congress of Neurological Surgeons, is your most complete window to the contemporary field of neurosurgery. Members of the Congress and non-member subscribers receive 3,000 pages per year packed with the very latest science, technology, and medicine, not to mention full-text online access to the world's most complete, up-to-the-minute neurosurgery resource. For professionals aware of the rapid pace of developments in the field, Neurosurgery is nothing short of indispensable.

About Lippincott Williams & Wilkins
Lippincott Williams & Wilkins (LWW) is a leading international publisher for healthcare professionals and students with nearly 300 periodicals and 1,500 books in more than 100 disciplines publishing under the LWW brand, as well as content-based sites and online corporate and customer services.

LWW is part of Wolters Kluwer Health, a leading global provider of information, business intelligence and point-of-care solutions for the healthcare industry. Wolters Kluwer Health is part of Wolters Kluwer, a market-leading global information services company with 2010 annual revenues of €3.6 billion ($4.7 billion).

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Encouraging Results with Stem Cell Transplant for Brain Injury

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