April 21, 2009

Can China Cure? A testimonial

This comment arrived today. The hospital referenced is here. The stem cell “treatment” center is on the home page. Wang Xiaojuan is apparently the director of neurology: here’s her Zoom Info. Read on:

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I’d like to share my disappointment with the results of the stem cell treatment that I received from Tiantan Puhua Hospital from 21 July to 23 August 2008.

Due to the effects of a head injury resulting from an accident in Malaysia in September 2006, I was having problems with my muscle movements and I was unable to walk normally unaided. Despite the various treatments that I received in Malaysia, I was unable to solve my problems.

After receiving good references about the hospital, I enquired about the various treatments available and was recommended to undergo the stem cell treatment. I was informed that the hospital uses the newest neurological approaches to provide effective and safe stem cell treatments to a wide range of neurological disorders. The treatments consisted of stem cell transplantation, intensive physiotherapy and medicine which have proven to be efficient in bringing high levels of recovery to its patients.

The doctors at the hospital namely, Dr Wang Xiaojuan and Dr Wu Li Ke assured me that the treatment would be effective and I would be able to recover my movements within 6 months from the completion of the treatment.

Based on the representations made by the doctors, I paid the amount of EUR28,000 prior to the treatment and flew from all the way from Malaysia and stayed in China for the aforesaid period to undergo the treatment.

I was only given four stem cell transplantations during my stay in China although I requested for more. I was willing to pay extra for the additional transplantations but the doctors informed me that it was not necessary. According to them, the four stem cell transplantations would be sufficient to ensure that my problems would be resolved.

It has been approximately 8 months since the completion of the treatment and despite following the advice of the doctors and undergoing physiotherapy every day, my condition has not improved.

Despite having incurred substantial costs including medical fees amounting to EUR26,028 (excluding refund of EUR1,972), flight expenses and accommodation costs of my stay in Grand Hyatt Beijing and spending more than 1 month at the hospital, the treatment that I have received has not been effective at all. I also had to endure the hassle of commuting from the hotel to the hospital everyday which would involve me leaving the hospital as late as 7.00 pm daily.

I am very frustrated that the representations made to me by the doctors have not been fulfilled. Based on the results of the my treatment, the hospital has not lived up to its reputation of having renowned doctors, advanced medical facilities and cutting edge research.

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April 17, 2009

How Many Embryonic Stem Cell Lines?

It’s anybody’s guess.

The National Institutes of Health held a special teleconference today outlining its draft guidelines for embryonic stem cell research. The guidelines are now open for public comment.

Among other things, the feds estimate there are hundreds of lines world wide. Until we know more, take the figure with a grain of salt.

Listen to a replay of the meeting by calling this number: 1-866-290-0880 and enter passcode 4086085.

You can find the draft guidelines here.

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March 31, 2009

Chimeras Attack! Jane Goodall Missing

Christopher Thomas Scott
World Press International

Port of San Francisco: April 1, 2009

The creepy contents of a container ship from the remote island of St. Moreau has wreaked havoc on the streets of San Francisco. One of the containers broke loose from its moorings and spilled its frightening freight on Pier 35, across from  the historic Coit Tower and near the city’s popular Embarcadero, a haven for joggers, sightseers, and other marginally fit people wearing too-tight Lycra.

The ghoulish goods: a swarm of angry chimeras, made by the island’s crack-smoking scientists. The dopers were attempting to ship the crazed creatures to the Las Vegas branch of the Cirque de Soleil. For years, Congress has tried to shut down the evil operation after Kansas Senator Sam Brownback lost his mother-in-law while she was sunbathing on St. Moreau’s famed pink sand beaches. A human-animal chimera that had escaped from  a nearby lab dragged the poor woman into a nearby swamp and devoured her. Witnesses say the freakish fiend bore a strange resemblance to Henry Kissinger. The former shuttle diplomat has not been seen in public for years. chimeras2

San Francisco is at threat level red

An especially nasty interspecies chimera, called a Great White Tabby (see photo), severed the limbs of several skateboarders. Bystanders said the youths were taunting the fish–er, cat–with a laser pointer. Wealthy residents of Nob Hill were seen fleeing down California street, making frantic but unsuccessful calls on their AT&T powered iPhones. A pack of Reptiliostriches were in hot pursuit, clearly enraged by the  expensive handbags and shoes the citizens had grabbed as they ran from their mansions.

The National Guard announced they had set up a perimeter around the city and closed the Golden Gate Bridge.

After a sighting of a Chihuahua sporting boxing shorts and a Popeye-like pair of forearms, several  chimera experts, including authors of the National Academies’ Guidelines for Embryonic Stem Cell Research were summoned to the city. The report, among other things, warns of the unhappy consequences of mixing animal and human cells.  They joined officials from the world’s largest zoos and primate expert Jane Goodall. Plans for ridding San Francisco of the  violent varmints went awry when Goodall, 10,000 protesters wearing Grateful Dead t-shirts, and hundreds of PETA members chained themselves to various city monuments.

Goodall’s fate remains unknown.

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March 31, 2009

March Stem Cell Roundup

A month to remember. Obama reverses eight years of backsliding by revoking the Bush restrictions on embryonic stem cell research: much applause. But Bush’s presidential ethics advisors make one last stand before they leave for other pastures. The California Institute for Regenerative Medicine gets thumped by a out-of-sorts essayist. Texas gets religion (of a sort). Teaching Darwin’s theory survives in Texas but the complexity of cells doesn’t. Rudolf Jaenisch once told me about the egg’s amazing ability to reprogram. “It’s just chemistry!” he said.  He may be right: a group at Wisconsin makes induced pluripotent stem (iPS) cells without vectors or genes.  The Brits say they’ve got a way to make blood from human embryonic stem cells. Science crusader William Saletan dissects the story in Georgia: preimplantation genetic diagnosis (PGD). My prediction: religious conservatives will move their battle gear from Washington to the states. Georgetown University researchers reprogram stem cells from the testes (yup, stem cells found there, too) to become like embryonic cells–in other words, powerful enough to make various cell and tissue types.

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March 28, 2009

Stem Cell Trials: Green Light/Red Light

When thinking about the first human clinical trials, good ethics demands good evidence. The International Campaign for Cures of Spinal Cord Injury guidelines state: “A study involving risk to human subjects is not ethically defensible if it is not scientifically defensible.” The first experiments are designed to test risk, not to provide benefit. Assuming the study passes the safety threshold, the next steps determine the best dose for the desired beneficial result.

Unlike small molecule drugs, stem cells are living corpuscles that repair and renew tissues and organs. What are some of the ethical and scientific issues to consider before green-lighting a new stem cell clinical trial using neural stem cells or the mature cells made from them?

  1. The risk calculation depends on which cells are used and how they are cultured. For the central nervous system, flexible stem cells rather than their progeny–the neurons–may be necessary for long-term repair.
  2. Stem cells are less predictable and more proliferative than neurons.
  3. Unmatched cell transplants will require immune suppressant drugs.
  4. When using embryonic cells to make neural stem cells, the more times a neural stem cell line is transferred from an old culture to a new culture (called a passage) the less of a chance of tumor causing stray pluripotent cells.
  5. But, more time in culture means more time to accrue genetic instability and other problems.
  6. The International Campaign for Cures of Spinal Cord Injury recommends that the first trials transplant only to thoracic regions of the spinal cord. Cervical or lumbar sites are riskier because an adverse event could affect respiratory, upper limb and lower limb function.
  7. Even if a transplant has no adverse effects, subjects who leap into the first clinical trials may find themselves excluded from subsequent trials using improved techniques. Rigorous clinical trials will likely accept only untreated patients, as previous treatments would be a confounding variable.

Balancing tradeoffs such as these have long been a part of the larger discussion about when to begin the first human experiments using untested technologies.

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March 26, 2009

Presidential Advisors Sound Off

Ten out of eighteen members of President’s Council on Bioethics–appointed during the Bush administration–issued this statement today in the Hastings Center Bioethics Forum. The following is excerpted from their press release.

Keep your eye out for a round of new appointments.

Their commentary raises three concerns:

1) The policy under President Bush was inaccurately characterized. While President Obama characterized his action as “`lift[ing] the ban on federal funding for promising embryonic stem cell research’,” they write, the policy under President Bush “did not ban federal funding of embryonic stem cell research; rather, for the first time, it provided and endorsed such funding (as long as the stem cell lines had been derived prior to that date). The aim of this policy was not to shackle scientific research but to find a way to reconcile the need for research with the moral concerns people have.”

2) President Bush’s policy was advancing research within ethical norms more effectively than President Obama’s will. The commentary asserts that the policy under president Bush was well on its way to “advancing biomedical science and upholding ethical norms,” two goals outlined in the 2005 Council white paper titled Alternative Sources of Human Pluripotent Stem Cells. Since then, researchers have made progress on alternative methods of obtaining stem cells, particularly in reprogramming somatic cells in order to restore them to a pluripotent condition. “With respect to the progress that had been made in reconciling the needs of research and the moral concerns of many Americans, we can only judge, therefore, that the president’s action has taken a step backward, and we regret that.”

3) The risk of reproductive cloning still must be addressed. The group offers what they say is needed clarification on President Obama’s promise to “ensure that our government never opens the door to the use of cloning for human reproduction.” They write that the president’s announced policy would permit federal funding of research not only on stem cell lines derived from IVF embryos, “but also on lines derived from created and/or cloned embryos. In the latter two cases, we would be producing embryos simply in order to use them for our purposes.” Furthermore, to prevent such cloned embryos from being used reproductively, “the government would find itself in the unsavory position of designating a class of embryos that it would be a felony not to destroy.”

Benjamin Carson, M.D.
Nicholas Eberstadt, Ph.D.
Jean Bethke Elshtain, Ph.D.
Alfonso Gómez-Lobo, Dr. Phil.
William Hurlbut, M.D.
Donald Landry, M.D., Ph.D.
Peter Lawler, Ph.D.
Paul McHugh, M.D
Gilbert Meilaender, Ph.D.
Diana Schaub, Ph.D.

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March 21, 2009

The Stem Cell Clinical Trials Index (2)

by Christopher Scott

In July 2007 I did a quick rundown of stem cell clinical trials found in the world’s largest registry, ClinicalTrials.gov. Then the registry contained information on 45,000 federally and privately supported clinical trials in 140 countries. Since then the database has exploded to over 70,000 records in 165 countries. The website was launched by the National Institutes of Health on the heels of legislation calling for a comprehensive, publicly accessible repository for clinical trials. In 2004, a group of medical journals published a consensus statement in the New England Journal of Medicine that essentially said to anyone conducting clinical research: “if you want to publish in our journals, then you need to put your trials in a public registry (and, by the way, ClinicalTrials.gov is the place to put them).”

Not surprisingly, the number of records skyrocketed soon after.  Here’s a rough curve of the growth of the number of records (taken from the published literature at various timepoints and in some years extrapolated).

ct_gov_growth1

According to ClinicalTrials.gov, how many stem cell trials might there be?

I ran the search again using the site’s advanced search algorithm. Note that most are hematology/oncology studies, and that each hit may not be a true stem cell trial. The parenthetical number is the first result, followed by the percent increase.

  1. aggregate increase in clinical trials records = 70,000 (45,000) +55%
  2. trials with a mention of “stem cell” = 2319 (709) +227%
  3. “heart disease” + “stem cell” = 118 (56) +110%
  4. diabetes + “stem cell” = 21 (11) +91%
  5. Parkinsons + “stem cell” = 0 (1) -100%
  6. “stem cell” + China =17 ( 7) +143%
  7. “stem cell” + Germany = 128 (73) +75%
  8. “cord blood stem cell” = 18 (59) -69%
  9. trials using cells made from embryonic stem cells = 0
  10. trials with “gene therapy” as the intervention = 334
  11. trials with “stem cells” as the intervention = 1861

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March 20, 2009

Guidance for Obama

A few months ago I helped policymakers at the Center for American Progress as they wrote their new report, “A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically.” The back pages of the document, authored by Michael Rugnetta of CAP and Michael Peroski, includes good information and references  about stem cell research policy and ethics.

Here are four key recommendations from the report. It calls for support of embryonic stem cell research in which:

  • The stem cells come from embryos that were originally created at in vitro fertilization clinics for the purpose of fertility treatment and are now stored at these clinics because more were created than required to fulfill the patient’s clinical need
  • Proper written informed consent is obtained from the donors.
  • As part of the informed consent process, the embryo donors determine along with the physician that the embryos will never be implanted in a womb and would otherwise be destroyed.
  • There are no financial inducements and the donors understand the purpose of the research is not to eventually confer therapeutic benefits upon the donors.

The report recommends that Congress move immediately to enact legislation that would instruct the HHS and the NIH to provide funding for embryonic stem cell research. Bills were previously introduced and passed in the House and Senate but vetoed by then president Bush.

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March 11, 2009

The Leader in Stem Cell Research? The US.

Which country gets the most embryonic stem cells for research?

The US.

The graph below comes from our research at Stanford (with my collaborators at Mayo Clinic and the University of Michigan), featured on the cover of the March issue of the journal Cell Stem Cell. We examined the world’s largest stem cell banks, in Wisconsin and at Harvard University. Twice as many shipments go to US researchers compared to rest of the world. The worldwide demand by scientists for embryonic stem cells is very strong. Way, way stronger than for credit default swap derivatives.

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March 10, 2009

The Stem Cell Decade

Let’s call two of the biggest breakthroughs in stem cell biology, “from skin to skin.” A run-of-the-mill skin cell was the star player in each, bookends to an amazing decade of discovery.

In 1997, the journal Science named Dolly, a lamb cloned from a single skin cell of an adult sheep, as its Breakthrough of the Year. Her creation by the Scottish researcher Ian Wilmut demonstrated the power of cloning technology, surprising both researchers and the public. Importantly, Dolly ignited a fierce debate about the ethics of human reproductive cloning. Although mammals had been cloned before, conventional wisdom had held that older cells could not give rise to new, mature organisms.

Reprogramming–turning a skin cell into an embryonic-like cell by inserting special genes, was first runner-up in 2007 when three research groups reported the feat. In 2008, the technology went on a tear, moving the discovery to Science’s number one position. Using the method, two research groups showed that immortal cell lines could be made for at least 10 different diseases, providing scientists with new tools to study the molecular basis of disease, new systems for discovering drugs and most importantly, the potential of a genetically matched cells and tissues to repair and replace damaged tissue.

As it happens, both discoveries–resetting DNA of a skin cell to it’s embryonic state–had something in common. Epigenetics, or changing the expression of genes without changing the sequence of the genetic code, is at the core of each. These discoveries, and many in between, lit fire to another area of science, the genetics of reprogramming.

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