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Harris Stowe State University Hosts Successful Bone Marrow Drive

A shortage of blood and stem cells in the black community is costing lives, Canada's blood agency warns.

Canadian Blood Services is calling on people of African and Caribbean heritage to register as blood and stem donors through its OneMatch Stem Cell and Marrow Network.

Sickle cell disease is an inherited disease of red blood cells, predominantly affecting people of African descent. In people with sickle cell disease, the red blood cells are abnormally shaped and starve tissues of oxygen.

The lifespan of affected people is about three decades shorter than average, said Dr. Isaac Odame, medical director of the Global Sickle Cell Disease Network at the Hospital for Sick Children in Toronto.

Complications can include infections, extreme bone pain and damage to the brain, lungs, heart and kidneys, Odame said.

Kynan Jackson, 7, of Halifax struggles with painful sickle cell disease. He takes medication twice a day, has had blood transfusions and been admitted to the hospital a few times since he was diagnosed at age four.

“It is stressful,” said his mother, Winnell Jackson. “It's almost like a waiting game. The medication won't ever stop him from getting crisis again, so I know it's coming.”

A stem cell transplant replaces the bad, misshapen ones with normal ones, said Odame.

“The only way to give him [Kynan] a chance is to cure it,” Odame said. “We know that it can be cured through stem cell transplantation.”

Stem cell transplants require a close match from a donor of the same ethnic background, which narrows Kynan's odds of getting one.

“If you are Caucasian and you're looking for an unrelated match, probably 75 per cent chance you will find one. If you are of African descent, your odds are far, far, far less,” Odame said.

Canada's blacks represent about 2.5 per cent of the population, based on the 2006 census. But of the 300,000 on the blood agency's stem cell and marrow registry, only 0.7 per cent are of African descent.

“Sometimes people wait six months to years to find a match and they may end up passing away in that time period because we can't find a match in Canada or around the world,” said Sue Smith, executive director of One Match.

During Black History Month, Canadian Blood Services is appealing for young, black male donors in particular to donate blood and be registered. Men tend to be bigger and deliver a larger volume of stem cells without the complications of an over-reactive immune system that can occur during pregnancy.

Currently, the agency said there is a waiting list of 36 African Canadians with cancer who could be cured with a stem cell transplant. Kynan's mom hopes the campaign is a success and she's able to see him grow up.

It would “be really nice to know that, you know what, he does have a match out there. There's somebody out there wherever they may be, that would match him and be able to take that pain, help ease that pain in his life.”

The blood agency's theme this year, “Our Canadian Story: Making Community Engagement a Priority,” emphasizes community.

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Blacks urged to donate blood, stem cells

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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
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Treating Brain Injuries With Stem Cell Transplants – Promising Results

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.

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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 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.

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Secrets of ailments unlocked by stem cells from skin samples

(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 www.ucdmc.ucdavis.edu/stemcellresearch.

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The promise of stem cell therapies forum

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.

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

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

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

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

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

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.

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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.

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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 

To order this report:Blood Supply, Tissue Banking and Transplantation Industry: Biobanking for Medicine: Technology and Market 2012-2022

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Biobanking for Medicine: Technology and Market 2012-2022

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Skin cells converted to brain cells without intermediate stem cell stage

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