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Advocacy group linked to stem cell industry asks medical board for less-strict rule

By Mary Ann Roser

AMERICAN-STATESMAN STAFF

An Austin-based group funded mainly by a company that develops stem cell therapies is petitioning the Texas Medical Board for a less-strict rule on adult stem cells an issue the board has struggled with for more than a year.

The board will hold a hearing April 13 on its proposed rule, which would require doctors to get informed consent from patients before performing a stem cell procedure as well as approval from an institutional review board.

Such boards review research to protect patients and are overseen by the U.S. Food and Drug Administration.

At the meeting, the board must either adopt or pull down the much-revised rule, said Mari Robinson, executive director of the medical board.

The group, MedRebels Foundation, which seeks to raise awareness and educate the public about stem cells, will present its petition at the hearing. It has more than 2,500 signatures, many of them gathered near the company's Red River Street office during the South by Southwest Music Conference and Festival, Executive Director Shay McBurney said Friday. The office space is provided by SpineSmith and its parent, Celling Biosciences, which develops products and therapies using a person's own adult stem cells.

The petition asks the board not to put any additional restrictions on adult stem cells that are obtained from a patient's own body, provided they are used in the same medical procedure and not extensively processed or grown outside the body, frozen or stored.

"We were pretty amazed at how many people came and signed our petition," McBurney said.

MedRebels hopes the medical board recognizes that there are different types of stem cells, unlike its proposed rule, which "would classify all stem cells in the same bucket," said Matthew Murphy, a senior scientist at Celling Biosciences who spoke on behalf of MedRebels.

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Advocacy group linked to stem cell industry asks medical board for less-strict rule

Treating cancer as a chronic disease?

ScienceDaily (Mar. 29, 2012) New research from the Technion-Israel Institute of Technology Rappaport Faculty of Medicine and Research Institute and the Rambam Medical Center may lead to the development of new methods for controlling the growth of cancer, and perhaps lead to treatments that will transform cancer from a lethal disease to a chronic, manageable one, similar to AIDS.

By placing cancer cells in and near a growth developed from a population of human stem cells, scientists have demonstrated that the cancer cells grow and proliferate more robustly when exposed to human cells than they do in a typical petri dish or mouse model. The cancer cell population is also more diverse than had previously been understood. The research was published in the current advanced online issue of the journal Stem Cells. Maty Tzukerman, Rambam senior research scientist and the project leader and senior co-author on the report, says that this model will facilitate targeted drug discovery aimed at blocking the cancer cell self-renewal process.

Previous studies have determined that some tumor cells appear to be differentiated, while others retain the self-renewal property that makes cancer so deadly. According to Technion Professor Karl Skorecki, director of Medical Research and Development at Rambam Health Care Campus and senior co-author on the report, this new research attempts to understand how cancer grows, and to find ways to halt the runaway replication.

In order to mimic the human cancer environment as closely as possible, the research team developed a teratoma -- a tumor made of a heterogenous mix of cells and tissues -- by enabling the differentiation of human embryonic stem cells into a variety of normally occurring human cell lines on a carrier mouse. The human cellular teratoma constitutes a new platform of healthy human cells for monitoring the behavior and proliferation of human cancer cells.

For this study, the team took cells from one woman's ovarian clear cell carcinoma and injected them either into or alongside the human stem cell-derived environment. "We noticed very early on, rather strikingly, that the human cancer cells grow more robustly when they are in the teratoma environment compared to any other means in which we grew them, such as in a mouse muscle or under the skin of a mouse," says Skorecki.

The scientists were able to tease out six different kinds of self-renewing cells, based on behavior -- how quickly they grow, how aggressive they are, how they differentiate -- and on their molecular profile. This was a previously unknown finding, that one tumor might have such a diversity of cells with crucial fundamental growth properties. Tzukerman explains that the growth of the cancer cell subpopulations can now be explained by their proximity to the human cell environment.

The researchers cloned and expanded the six distinct cell populations and injected them into the human stem cell teratomas. One key observation is that some cells, which were not self-replicating in any other model, became self-replicating when exposed to the human cells.

Skorecki said that while he wasn't surprised that the human environment affected the growth, he was in fact surprised by the magnitude of the effect: "We've known for years now that cancers are complex organs, but I didn't think the power of the human stem cell environment would be so robust, that it would make such a big difference in how the cells were grown."

The researchers point out that they do not yet know the cues that particularly enhance the cancer's proliferation, and the team is now working on isolating the factors from human cells that promote such plasticity and self-renewing properties. The scientists explain that this may eventually allow physicians to manage cancer as a chronic disease: instead of one therapy against the entire tumor, researchers may develop a method to tease out the variety of self-renewing cell lines of a particular tumor and determine what allows each to thrive, then attack that mechanism.

Skorecki and Tzukerman say that an important next step in this line of cancer research will be to identify and develop ways of blocking the factor or factors that promote this essential self-renewing property of cancer, thus relegating many forms of cancer to controllable, chronic diseases.

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Stem cell institute to work with foreign agencies

California's $3 billion stem cell agency, now more than 7 years old, has joined research partnerships with science and health agencies in eight foreign countries, the San Francisco institute announced.

The agreements call for collaboration in efforts aimed at speeding stem cell research from the laboratory to the hospital, where researchers hope that basic human cells will be programmed to treat scores of human degenerative diseases.

Research partnerships between American and foreign stem cell scientists are encouraged, but the California institute's funds would only be spent within the state, institute officials said.

Alan Trounson, president of the California Institute for Regenerative Medicine, signed agreements with stem cell funding agencies in Brazil and Argentina last week, he said Thursday.

"Both Brazil and Argentina have strong and robust stem cell research communities in basic science and transitional clinical science, which should create exciting synergies with many scientists in California," Trounson said in a statement.

He has signed similar pacts with stem cell agencies in Canada, Britain, France, Spain, Australia, Japan, China and Indiana.

The California institute was created in 2004 after Proposition 71, a $3 billion bond issue, was approved by California voters at a time when use of federal funds was barred for research into the promising field of embryonic stem cells.

So far the state agency has committed $1.2 billion to scientists and training centers at 56 California institutions, and the rest of the bond money should last until 2020, a spokesman said.

This article appeared on page C - 9 of the SanFranciscoChronicle

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Stem cell institute to work with foreign agencies

The fight to walk

Daniel Leonard is doing all he can to walk again, and after a recent course of stem cell treatment hes as close as he has been since a few months after the 2005 injury that put him a wheelchair.

He was 22 years old and about to begin his third year of college when he woke up one August morning on the floor at his familys Johnson City home unable to move and struggling to breathe.

While the cause of his injury remains a mystery, what is known is that three vertebrae near the top of his spine had been crushed, leaving him paralyzed from the neck down, on a ventilator and not expected to never walk or even breathe on his own again.

Six months after undergoing surgery to remove the bone fragments from his spinal cord, Leonard, who had played several sports in high school and was boxing at the Johnson City Athletic club prior to his injury, was exceeding all expectations.

In treatment at the Patricia Neal Rehabilitation Center in Knoxville, he was not only breathing independently, he was pulling himself up on parallel bars and being fitted with leg braces to help him take his first steps.

Then the unthinkable happed, again. Because there had been nothing done to stabilize his damaged vertebrae, his spine collapsed at the site of his injury and all of his progress was lost.

I worked my butt off to get to the point I was about to start walking, he said. But the gains he had made in upper body strength were erased and there was no longer any movement in his legs.

After a second surgery to fuse the bones, his condition was labeled as incomplete paraplegia characterized by limited movement and sensation in all the muscles below his neck and none at all in his legs. Doctors told his family he would never be able to move his legs, and for many years he could not.

For a while, he lived independently with the assistance of a caregiver. When his caregiver left, he moved to a nursing home, expecting to stay only long enough to find another place and another caregiver. But without money to finance that plan, months turned into years and the Four Oaks Health Care Center in Jonesborough became his home for the long term.

Early last year, things took a turn for the better when for reasons unknown he began to regain some movement in his legs. Encouraged, Leonard once again threw all his effort into physical therapy. In October, he began working out regularly with Amy Caperton, a personal trainer at the Tri-Cities Lifestyles fitness center in Johnson City, and coupled that with physical therapy at the new Mountain States Rehabilitation Center.

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The fight to walk

Eastday-Rejected by donor, leukemia patient saved by mother

A leukemia patient who was twice turned down by a Shanghai stem cell donor recovered from the disease after receiving her mother's half-match stem cells and a unit of umbilical cord blood from Shanghai.

Jiang Jing, a 23-year-old Jiangsu Province native, left the transplant cabin at No. 1 Hospital affiliated with Suzhou University yesterday, fully recovered.

Jiang's saga was dramatic. She was diagnosed with acute leukemia on April 1 last year and was informed by the hospital that a full match donor was found in September. The transplant was scheduled for March 6 this year.

Jiang started to undergo therapy for stem cell transplant on February 24 to suppress her immune system, paving the way for the healthy stem cells from the donor, a Shanghai university student.

However the donor backed out on March 1. She agreed a second time to give a donation on March 5 but again backed away, this time leaving the hospital secretly at midnight after receiving an injection as preparation for the donation. There were reports that the would-be donor, who was not named, faced pressure from her family to forego the procedure.

Since medication had stopped Jiang's blood-forming function on March 6, she could survive for only seven days if not undergoing transplant. Doctors decided to transplant her mother's half-match stem cells and a unit of umbilical cord blood from the Shanghai Cord Blood Bank.

The umbilical cord blood, which had an 80 percent match to Jiang, was used to reduce rejection and streamline the transplant.

Though the incident had a happy ending, it has stirred wide discussion online as some web users accused the student of putting the patient's life in danger through her actions.

But health insiders said people must have the right to change their minds.

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Eastday-Rejected by donor, leukemia patient saved by mother

Vatican’s Stem-Cell Censorship Sham

The Catholic Church has never had a particularly easy relationship with science. After all, this is the institution that sentenced Galileo Galilei as a heretic for his theories on the universe during the Roman Inquisition. Two thousand years later, the church forgave Galileo and called the whole misunderstanding a tragic mutual incomprehension but it remains safe to say the Vatican doesnt have a great track record when it comes to empirical open-mindedness.

So onlookers were surprised when the Vatican announced it would be hosting a global conference on the highly controversial issue of stem-cell research in Rome over four days in late April. The church held a similar conference in 2010 and 2011, which focused on its recommendation that stem-cell research should be limited to adult cells that can be harvested from live donors, not embryonic cells that destroy the source. But this years conference schedule featured some of the worlds foremost experts in embryonic research as keynote speakersleading some scientists to think that the Vatican might actually be looking for enlightenment on the topic.

That was not exactly case. Instead, the Vatican seems to have hoped that by including embryonic researchers in the program, it would appear that these scientists actually endorsed the Vaticans stance.

It might have worked to some extent, but after some of the speakers declined to censor their speeches, the Vatican abruptly canceled the conference altogether. According to the conference website, the event was canceled due to serious economic and logistic-organizational reasons that have completely jeopardized the success of the 3rd International Congress on Responsible Stem Cell Research. The scientists who were planning to attend say they are being stifled instead. I think the only interpretation is that we are being censored, Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, said in a statement. It is very disappointing that they are unwilling to hear the truth.

Just what was the Vatican thinking? Inviting embryonic stem-cell researchers to a conference and then denying them the right to talk about their field of expertise was a major gamble. Had the speakers agreed to avoid reference to embryonic research, it would have given the disingenuous impression that they endorse the Holy Sees recommendation on adult stem-cell research only. Did the Vatican really think they could control the scientific community? Apparently so. Father Scott Borgman of the Pontifical Academy for Life, which co-organized the conference, had reportedly asked the speakers to limit their discussions to adult stem-cell research only. George Daly, a leading embryonic researcher with the Childrens Hospital in Boston, says he was actually told not to make embryonic researchhis field of expertisea focal point of his talk. When he told Borgman that he would still be touching on the topic in a historical context, higher-ups in the Vatican reportedly panicked. I had been encouraged to think that the Congress would be a forum for discussion of many areas of common interest to the Vatican and stem cell scientists, regardless of the disagreements over embryonic stem cells, Daly told The Daily Beast. We should all agree that clinical trials of new medical treatments based on stem cells should proceed according to rigorous principles to ensure patients are kept as safe as possible and free from exploitation. And we should all agree that premature claims of therapeutic efficacy and direct marketing of unproven interventions to vulnerable patients is a threat to legitimate attempts to develop experimental stem cell medicines.

Pope Benedict looks on during the mass in solemnity of the chair of St. Peter with new Cardinals in St. Peter's basilica at the Vatican on February 19, 2012. The Vatican stands by its decision to cancel the controversial conference as having a purely business motive. , Alberto Pizzoli, AFP / Getty Images

With the cancelation of the event, discourse between the two diverse entities will not have a venue. One Vatican official told the Catholic News Service that many of the Vaticans leaders were secretly glad the conference failed. I am infinitely relieved that the church has avoided a major blunder which would have confused the faithful for decades to come, the unnamed source said. The Holy Spirit has certainly shown to be present through those faithful members who drew attention to the ambiguity of the choice of speakers. I hope and pray that a review will be affected of the basis on which these congresses are planned.

Some stem-cell researchers are also relieved the conference wont go on. I personally am very uncomfortable with a scientific meeting run by a church, and one at which only certain types of science and scientists are allowed to attend, blogged Paul Knoepfler, an associate professor of Cell Biology and Human Anatomy at UC Davis School of Medicine who blogs about stem cell research at IPCell.com. Also I cant help but wonder, what would be the reaction if someone like Daley spent a few minutes of his talk discussing his embryonic cell research in a very nonconfrontational way? Would he be tasered or drop through some trap door straight to Hell?

Still, Knoepfler was hopeful. I view the canceled Vatican stem-cell meeting as a missed opportunity for a very much needed, open dialogue about stem cells, he told The Daily Beast. More specifically, I believe the reasons for the cancellation reflect an anti-scientific attitude by the highest level of Vatican leaders. More simply put, the attitude might be summed up by the phrase If you do not think like us, you are not welcome at our meeting, and well go so far as to cancel the whole thing to avoid your presence.

Inviting embryonic stem-cell researchers to a conference and then denying them the right to talk about their field of expertise was a major gamble.

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Vatican’s Stem-Cell Censorship Sham

U-M Would Have To Report Data On Stell Cell Research In New House Bill

LANSING - The University of Michigan would have to report data on its stem cell research and Michigan State University would have to end its policy of requiring students to have health insurance if they want a piece of the $36 million in performance funding in changes made Friday by the Michigan House Appropriations Higher Education Subcommittee.

The committee, which reported the bill (HB 5377) along party lines, fundamentally changed the performance funding metrics proposed by Governor Rick Snyder.

To qualify for the money, universities would have a limit on tuition increase looking at a two-year basis, report embryonic stem cell research, participate in reverse transfer agreements with at least three community colleges in the state, ensure their dual enrollment policy doesn't consider use of credits toward high school graduation requirements and that the universities don't compel undergraduate students to carry health insurance.

U-M is the only university that conducts stem cell research and MSU is the only university that compels students to have health insurance. The Republican members of the subcommittee were clearly upset with the universities during testimony on those issues earlier this year.

Rep. Bob Genetski II (R-Saugatuck), the subcommittee chair, said the budget does not target anyone.

Rep. Joan Bauer (D-Lansing), the subcommittee's minority vice chair, vehemently disagreed and said such obvious punitive language has no place in the higher education budget.

"It really verges on social engineering," said Mike Boulus, executive director of the Presidents Council, State Universities of Michigan.

This story was provided by Gongwer News Service. To subscribe, click on Gongwer.Com

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U-M Would Have To Report Data On Stell Cell Research In New House Bill

Newly identified stem cells may hold clues to colon cancer

Public release date: 29-Mar-2012 [ | E-mail | Share ]

Contact: Melissa Marino melissa.marino@vanderbilt.edu 615-322-4747 Vanderbilt University Medical Center

Vanderbilt-Ingram Cancer Center researchers have identified a new population of intestinal stem cells that may hold clues to the origin of colorectal cancer.

This new stem cell population, reported March 30 in the journal Cell, appears to be relatively quiescent (inactive) in contrast to the recent discovery of intestinal stem cells that multiply rapidly and is marked by a protein, Lrig1, that may act as a "brake" on cell growth and proliferation.

The researchers have also developed a new and clinically relevant mouse model of colorectal cancer that investigators can now use to better understand where and how the disease arises, as well as for probing new therapeutic targets.

Colorectal cancer is the second leading cause of cancer deaths in the United States. These tumors are thought to arise from a series of mutations in intestinal stem cells, which are long-lived, self-renewing cells that gives rise to all cell types in the intestinal tract.

For more than 30 years, scientists believed that intestinal stem cells were primarily quiescent, proliferating only rarely in order to protect the tissue against cancer. Then, in 2007, researchers reported finding a population of intestinal stem cells (marked by the molecule Lgr5) that were highly proliferative.

Those findings "really changed the way we think about intestinal stem cells," said Robert Coffey, Jr., M.D., Ingram Professor of Cancer Research, co-chair of Vanderbilt's Epithelial Biology Center and senior author on the study.

"It came to so dominate the field that it raised the question about whether quiescent stem cells even existand that's where we enter into the picture."

Coffey's lab studies the epidermal growth factor (EGF) signaling pathway which includes a family of receptors known as ErbBs and its role in cancers of epithelial tissues, like the intestinal tract.

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Cancer research focuses on cell protein

LOS ANGELES Blocking "don't destroy me" signals that normally sit on the surface of tumor cells and render them resistant to immune-cell attack slows the growth of a broad range of human cancers when they're implanted in mice, researchers have found.

The approach, reported by immunologists at the Stanford University School of Medicine, was effective against ovarian, breast, colon, bladder, liver, prostate and brain cancer cells. If the work can be repeated in people, the approach may someday help doctors marshal defender cells in patients' own bodies to fight cancers, the researchers said.

Key to the work is a cell protein called CD47, which is already being investigated in the treatment of leukemia.

CD47 sits on cell membranes and communicates with various immune cells, including macrophages, which gobble up foreign invaders in the body. It plays an important role in the normal life cycle of healthy red blood cells, telling macrophages to leave the cells alone.

In the study, the scientists injected the animals with antibodies that bind to CD47 and block out its protective signal.

"If we can block this signal, we can get the immune system to eat (the cancer cells) up," said Stephen Willingham, a postdoctoral researcher in the laboratory of immunologist Dr. Irving Weissman at Stanford and first author of a paper about the work.

The Stanford team examined cancer cells removed from patients with a variety of types of solid tumors. It found that CD47 studded the membranes of almost all of the cancer cells in their sample, suggesting that it is a molecule common to all cancers.

Placing the cells in lab dishes, the team administered an antibody: a protein that binds to CD47 and blocks it from warding off immune system cells. Macrophages ate the cells.

The researchers then implanted human tumor cells in mice for further study. They allowed the cancers to grow, and administered the antibody against CD47.

Antibody treatment inhibited the growth of almost all of the solid tumors and was able to wipe out some smaller cancers altogether, according to the report, which was published Monday in the journal Proceedings of the National Academy of Sciences.

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ThermoGenesis Announces AABB Accreditation for Cord Blood Products Customer in China

RANCHO CORDOVA, Calif., March 29, 2012 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL - News), a leading supplier of innovative products and services that process and store adult stem cells, said today that its customer Beike Biotechnology Co., Ltd. (Beike) has become the first company in China to receive accreditation from the AABB (formerly the American Association of Blood Banks). AABB is an international, not-for-profit association representing nearly 2,000 institutions and 8,000 individuals involved in the fields of transfusion medicine and cellular therapies.

A leading stem cell and regenerative medicine company in China, Beike will be using ThermoGenesis' AXP AutoXpress (AXP) and BioArchive Systems for the processing and storage of stem cells from cord blood. The Company expects the AXP device to receive registration approval in China during the current year.

Beike produces a full line of products derived from umbilical cord tissue, cord blood and bone marrow stem cells. It also operates three stand-alone cord blood processing and storage facilities, 18 specialized laboratories processing cord blood collection, five stem cell banks and two stem cell research laboratories.

"This AABB accreditation represents a major accomplishment for Beike and demonstrates its leadership position in China's regenerative medicine sector. It provides Beike a strong platform from which to further develop what we believe will be an increasingly prosperous cord blood stem cell market in China. We are pleased to be providing them our market leading tools to realize their strategy," said Matthew Plavan, Chief Executive Officer of ThermoGenesis.

"We are delighted to become the first bank in China to receive AABB accreditation for the processing and storage of cord blood and cord tissue. Our adoption of the AXP and BioArchive technologies is a critical component of our market vision to become the country's technology and quality leader in cord blood processing and storage," said Dr. Shengqin Ye, Chief Executive Officer of Beike.

About ThermoGenesis Corp.

ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include:

This press release contains forward-looking statements. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors including timing of FDA and foreign regulatory approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2012, and introduction of competitive products and other factors beyond our control could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2012. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

ThermoGenesis Corp. Web site: http://www.thermogenesis.com Contact: Investor Relations +1-916-858-5107, or ir@thermogenesis.com

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ThermoGenesis Announces AABB Accreditation for Cord Blood Products Customer in China