Geron Corporation announced on Monday that it was discontinuing research and development efforts related to stem cell therapies, and focusing its corporate strategy on the development of cancer treating drugs. As a result, the company will eliminate almost 40% of its workforce and close its ongoing GRNOPC1 clinical trial to new patients. There are currently four patients in the trial, who are receiving treatments of embryonic stem cells in order to evaluate whether such cells can safely be introduced into persons suffering with recent spinal cord injuries.  The Medical College of Wisconsin was participating in the clinical trial.

It is a sad day for those suffering from spinal cord injury and their loved ones.  The treatment pioneered by Geron has shown success in reversing paralysis in rats, and there is some optimism that it might lead to similar regeneration of nerve cells in humans.  Geron’s decision to end their research and development efforts does not reflect a determination that this line of research lacks promise.  Instead, the corporate decision reflects the cold hard fact that medical research takes years and costs millions, while the financial returns are uncertain and won’t be apparent until the distant future.  In other words, when it comes to stem cell therapies, the profit motive may not create a sufficient incentive for private industry to conduct the optimal amount of medical research that our society desires.

This is a topic covered extensively in my recent article on the funding of stem cell research, which argues that federal and state government funding is absolutely necessary in the field of basic medical research.  Unfortunately, stem cell researchers are facing the double whammy of a weak economy restricting corporate expenditures and, at the same time, a political environment that is focused on slashing government spending.

It doen’t help when opponents of embryonic stem cell research take every opportunity to make misleading statements about the alleged superiority of adult stem cells as a potential source for cures as compared to embryonic stem cells.  The latest example of this willful spread of misinformation comes from an unexpected source.  Tommy Thompson, who in 2008 at the Stem Cell Summit in Madison claimed to have single-handedly saved embryonic stem cell research when he served in the Bush Administration, delivered a speech at the Vatican recently where he argued that embryonic stem cell research was unnecessary and could be supplanted by adult stem cell research with little effect.

Thompson knows better.  He is well informed on the science of regenerative medicine, both from his time as Governor and Secretary of HHS, and also from his involvment with various stem cell companies in the private sector.  Such obsequious pandering from a candidate for public office is not pretty to see.

Our organization, Wisconsin Stem Cell Now, supports all forms of stem cell research.  We take this position for the simple reason that there is no scientific basis for picking one form of research versus another as a recipient of government funds.  We adamantly oppose efforts by certain interest groups to force a choice between embryonic and adult stem cell research for purely religious reasons.  Dr. Paul Knoepfler makes the case for why the choice between embryonic and adult stem cells is a false choice in a recent post on his blog.

My stem cell funding article makes a similar point: until there is some scientific basis for concluding that adult stem cells are superior to embryonic stem cells in all ways and as a treatment for all diseases, research must continue on multiple fronts.  Right now, each form of stem cell research presents certain advantages and certain disadvantages.  Our organization was founded because we want to help turn cures from a dream into a reality.  That won’t happen if our government artificially chooses ”winners” and “losers” among the different research approaches currently underway.

The Geron announcement points out the importance of the public funding of stem cell research.  The Tommy Thompson speech points out that the determination of where the public’s dollars will go is inevitably left in the hands of politicians.  These politicians are not above using their power to influence funding decisions as a vehicle for winning votes.

I suppose that the public has come to expect that politicians will use tax dollars for public works projects in a way that is designed to please their supporters and garner political suport.  But there seems to be something distinctly immoral about this practice when it is translated to the field of medical research.  The decision whether or not to fund one type of stem cell research should not be made with an intent to maximize the political benefit to the decisionmaker, especially where the consequences might be that promising medical treatments are delayed or even prematurely abandoned.

Ed Fallone is the President of Wisconsin Stem Cell Now Inc.

News today that the Massachusetts-based company Advanced Cell Technology has begun a clinical trial in London that uses embryonic stem cells to treat Stargardt’s disease, a form of juvenile blindness that afflicts upwards of 100,000 people a year. Previous experiments with rats have resulted in almost complete restoration of sight. This is the first European clinical trial using human embryonic stem cells on human patients. In the United States, there is currently one clinical trial underway using human embryonic stem cells, an experimental treatment for spinal cord injuries. More details can found in this article by Kerry Sheridan from the global news organization AFP:
http://tinyurl.com/3he44wh

In Sunday’s edition of the Milwaukee Journal-Sentinel, Tom Still describes the latest attempt by lawmakers in Wisconsin to place artificial restraints on medical research conducted within the state.  The bill in question, known as AB 214 and Senate Bill 172, would ban any medical research in Wisconsin using cells or tissue derived from aborted or miscarried fetuses.  As usual, what is presented to the public as a simple and uncontroversial legal provision is actually a “trojan horse” that would put a halt to important experimental treatments and also hamper the biomedical industry in the state, all in the name of furthering a religious viewpoint.

As explained in Tom’s piece, it is already against federal law to sell fetal tissue, and this proposed state law is unlikely to deter even one future abortion from taking place.  However, many existing medical products such as vaccines and numerous medical experiments currently underway at the University of Wisconsin and the Medical College all utilize cell lines that were derived from aborted fetuses decades ago.  These cells and tissues were donated for research lawfully, and with the full  consent of the parents, and a large body of scientific advances have been made over the years and continue to be made using these cells.  No purpose would be served in banning future experiments using these cells.

This is not an issue that directly affects stem cell research, although an argument can be made that some adult stem cell research, in particular research using induced pluripotent (or iPS) cells might be considered to have been partially derived using fetal tissue products.  This connection between fetal tissue and adult stem cell research is failry tangential, however.  In my opinion, application of the proposed law to restrict stem cell research appears unlikely.

But the legislation is yet another example of the misguided efforts of some state legislators to use religious criteria in order to classify some types of medical research as “good” and other types of medical research as “bad.”  This sort of legislative interference does two things.  First, it creates an uncertain legal environment that slows research, thereby adding years to the time that sick people have to wait until new treatments become available.  Second, these sorts of legislative pronouncements send a message to biomedical comapanies and academic researchers that they are not welcome in Wisconsin.

I’ll let Tom Still have the last word:

If the bill’s intent is to discourage abortions, it may miss the mark. Only eight UW-Madison researchers out of the hundreds on campus who use fetal cells derived their tissue from aborted fetuses, the campus reports.

In all eight cases, the tissue would have been discarded by abortion clinics if not donated for research. No aborted tissue was bought or sold.

Some lawmakers may also think they’ve found a backdoor way to ban human embryonic stem-cell research, but the bill would likely have the opposite effect.

James Thomson, a pioneer of human embryonic stem-cell research, also is the same UW-Madison scientist who launched the search for alternative methods of creating embryonic stem cells through reverse engineering of human skin and other cells. One of his lines of induced pluripotent stem cells, which are an alternative to embryonic stem cells, can be traced back to fetal lung tissue.

Thomson’s company, Cellular Dynamics International, also is one of the most successful start-ups in Wisconsin, having attracted about $100 million in venture capital so far. This is not the kind of company that should be tempted to move to California.

This is a bill that will hurt Wisconsin’s ability to create and retain tech-based jobs, its research institutions and people everywhere who suffer from diseases and other health conditions.

Let’s not roll back the clock on decades of medical progress.

Tom Still’s complete article can be read here:   http://www.jsonline.com/business/129592398.html

The Associated Press reports today that U.S. District Court Judge Royce Lamberth has dismissed a lawsuit challenging Obama Administration guidelines that permitted the federal funding of embryonic stem cell research. Judge Lamberth wrote that the D.C. Circuit Court of Appeals, when it overturned Judge Lamberth’s prior injunction halting the use of federal funds, had interpreted federal law in a way that permitted the federal funding of embryonic stem cell research. Therefore, Judge Lamberth ruled that he was bound by that interpretation of the law and that the entire lawsuit must be dismissed.

More on the story is available here: http://www.google.com/hostednews/ap/article/ALeqM5iPVGVZyr5PHwHMmFuKRq4eIIeZ0A?docId=6e2d2d08e7a541299ac806ff3827088e

I discuss the litigation in detail, and the policy debate over the funding of embryonic stem cell research, in an article available here:

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1747802

The Medical College of Wisconsin has announced its participation in a clinical trial for the treatment of spinal cord injury:

 The Medical College of Wisconsin has been selected as one of just seven sites nationwide for a groundbreaking clinical trial using human embryonic stem cells (hESC) to treat spinal cord injury.

The primary investigator is Shekar Kurpad, MD, associate professor of neurosurgery at the College. A total of ten patients will be enrolled nationwide in the Phase I study, which seeks to assess the safety and tolerability of hESC-derived oligodendrocyte progenitor cells. In animal studies, oligodendrocyte progenitor cells were shown to enhance remyelination of the spinal cord, and promote improvement of motor function.

The oligodendrocyte progenitor cells, or GRNOPC1, will be administered to patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

“This is a milestone in the fields of both stem cell and spinal cord research,” said Dr. Kurpad, who practices and will lead the trial at Froedtert Hospital. “Spinal cord injury is devastating to patients. We are hopeful that this trial will lead to increased knowledge about the possibility of regeneration of the spinal cord.”

Spinal cord injury is caused by trauma to the spinal cord that results in a loss of motor control, sensory perception, or bowel and bladder control. A blow to the spine can fracture or dislocate vertebrae that then injure the cells insulating the spinal cord. Every year, 12,000 people in the United States sustain spinal cord injuries. There are currently no approved therapies to treat spinal cord injury.

To date, two patients have been enrolled in the study. Neither suffered adverse effects related to the injection procedure or the GRNOPC1. As a result, the FDA has expanded the eligibility for the trial. Further information on the eligibility criteria is available on www.clinicaltrials.gov

 The press release can be viewed here.