Tag Archives: stem cells

Stem cells: Hope or hype? #ahcj13

The public’s hope for stem cell cures remain high, but scientists warn that many basic problems with this approach remain to be solved – and that investors demand profits far faster than research can be finished.

“We’ve created a system that is unrealistic and short sighted,” said Dr. Darrell Kotton, director of Center for Regenerative Medicine at Boston University’s Boston Medical Center.

Few of the 38 publicly traded stem cell companies will survive, said Philip Reilly, a physician, attorney and venture partner with Third Rock Ventures.

It is very difficult to produce returns in “venture time,” defined as less than five years, said Reilly. “There is tremendous disconnect,” between investors and biologists’ timelines, he said.

The best strategy, he believes, is for a small company to show data with enough promise – what he called “an inflection point” – that it wins the interest of a larger company, with the resources to carry the research across the finish line.

“Few will make it,” he said, of existing companies. At almost all, the cost per share has fallen below the opening price. “They were launched too soon.” Continue reading

Case could set precedent for regulating stem cells

On Forbes.com, Gergana Koleva digs deep into the ongoing court battle between Regenerative Sciences and the FDA over the question of whether stem cells “should be federally regulated as drugs.” While the treatment at issue isn’t generally a matter of life or death, the courts’ decisions in this case will have implications for other headline-grabbing stem cell treatments.

Human embryonic stem cells

(Photo: National Institutes of Health)

At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.

Regenerative and its allies argue that, because the therapy re-injects a patient’s own cells, it creates, as Koleva writes, “fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.” For its part, the FDA calls the therapy unproven and not guaranteed to be safe. In the end, the FDA indicates, it boils down to semantics.

Regulators have argued that the Regenexx procedure is equivalent to the administration of a drug because the stem cells that are re-injected into patients constitute an “‘article’ that is intended to treat, cure, and mitigate diseases and to affect the structure and function of the patient’s body,” therefore fitting within the definition of “drug.”

Society ‘snookered’ by research that isn’t new

Peggy Peck of MedPage Today found that research presented as new at the European Society of Cardiology’s annual meeting this weekend was actually published in July, despite the society’s requirement that information submitted for presentation must be new, unpublished data.

When asked by MedPage Today to point out the “news” in the Hot Line presentation, STAR lead investigator Bodo-Eckehard Strauer, MD, of the Heinrich Heine University of Düsseldorf, Germany, said the news was that bone marrow cell therapy significantly improved survival in patients with chronic cardiomyopathy, which he illustrated with a slide showing a Kaplan-Meier curve – the same graph that was published in the July issue of the European Journal of Heart Failure. Moreover, every data slide in Strauer’s presentation matched the tables in the published paper.

Following questions from MedPage Today, the organization acknowledged its error and has announced the researcher will not be allowed to present at its meetings for two years. Roberto Ferrari, M.D., president of the society, said the research had been accepted for presentation because they thought it had new data but that “We were snookered.”

Ruling puts stem cell research on hold

A federal judge’s ruling has, at least temporarily, blocked efforts to expand stem cell research, based on a decision that says “regulations designed to expand federal funding for embryonic stem cell research violated a law [the Dickey Wicker Amendment] prohibiting destruction of embryos for research purposes.”

When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health

When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health

It’s yet to be determined what the implications of this ruling [PDF] will be if it stands, but it could affect millions of dollars of federally-funded research. AHCJ has some background and links to help reporters who might be looking at how this will affect local researchers.

NIH rules more stem cells eligible for funding

Right off the bat let’s just note that the promised cures from stem cells have been slow in coming.

Science is hard. But many researchers trying to harness embryonic stem cells, which have the potential to produce any kind of cell in the human body, say restrictions on the cells that qualify for federal funding have made the work even harder. (AHCJ article – Covering stem cells: Background on science, politics and global competition)

Human embryonic stem cellsWhen stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health

Earlier this year the Obama administration rolled back limits from the Bush era that restricted federal funding to only a few cell lines. But it still hasn’t been clear which stem cells are OK and which are verboten.

The National Institutes of Health has waded in with clarifying guidelines that take effect today. The upshot: if the old cell lines were created ethically, then they should be good to go. The main issue is whether researchers got the appropriate consent of donors.

Next up, an NIH committee will pass judgment on existing cells and produce a Web site itemizing the ones that are legit.

“Every institution shouldn’t have to rediscover which cell lines are eligible for NIH funding, so having a registry is very practical,” George Q. Daley, a stem-cell researcher at Children’s Hospital Boston told The New York Times.

AHCJ resourcesCovering stem cells: Background on science, politics and global competition

Tip Sheet: Stem cell research in California

Intense competition in stem cell research: Mark Johnson of the Milwaukee Journal Sentinel writes a three-part series detailing the discovery of how to create embryonic stem cells out of normal cells. The online package includes a time-lapse video of an embryo’s first five days of development and links to a discussion about the ethics of stem cell research.

Obama order expected to increase speed, efficiency of stem cell research

National Center for Biotechnology Information

Medical Advances: Treatments, Cures, Possibilities: Presentations from this Knight Center for Specialized Journalism seminar are available.