FDA OKs human trials for therapies with embryonic stem cells

This morning the U.S. Food and Drug Administration approved the first human clinical trials using embryonic stem cells. The trials will be conducted by the Geron Corp. on humans suffering from paraplegia. The stem cells are those approved for use by President George W. Bush in 2001.

CNS will have a report on this next week. In the meantime, CNN has a story on the FDA announcement and an interview with company executives about the trials.

Catholic church leaders have spoken extensively about the ethics of using embryonic stem cells. Most recently Cardinal Francis E. George, president of the U.S. Conference of Catholic Bishops, wrote Jan. 19 to President Barack Obama discussing this and other health-related issues. Read the letter here.

In December, the Vatican issued a 32-page document, “Dignitatis Personae” (“The Dignity of a Person”) in which it warned of of the ethical dilemmas posed by new developments in stem cell research. Read the CNS story here.

Origins subscribers can see the entire Vatican document and related texts by logging into their subscriptions.

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8 Responses to FDA OKs human trials for therapies with embryonic stem cells

  1. a real person says:

    Thank goodness we have a new president that looks like he will not be influenced by the fringe groups, they seem to think they can decide for the rest of us what we should do. Freedom of choice is what America is founded on, once we let these loud fringe groups decide for us we will no longer have the ability to decide our own destinies. We the people need to stand up and quiet these pushy fringe groups only then will we be able to make great strides forward.

  2. love first says:

    I suffer from an immune disorder and unhealthy heart. I would never kill my smallest brothers and sisters– the embryos—to cure my disease. I accept what technology can bring that maintains my dignity as well as that of the preborn.

  3. Because of his abortion policy he is not President
    of the unborn child and permits the death of
    Americans his empeachment proceedings should
    not be delayed. He said he don t know when life
    begins. Does he know when his life began?
    It s sad when this man was elected to this office!!!!

  4. Jesse says:

    a real person, did you read Cardinal Francis George’s USCCB letter to the president? It clearly indicates that embryonic stem cell research has produced no medical breakthroughs compared to adult stem cell research (latest count: 50+ adult, 0 embryo). Not to mention embryonic stem cells have only resulted in uncontrollable growths and tumors when applied in testing. Why should we as a nation promote something ineffective and controversial when there is an effective and ethical alternative? He is speaking common sense that anyone pro life or pro choice should be able to agree with. We will only make great strides forward in this nation when we begin to love and cherish each and every human being, whether it be the poor, the outcast, the orphan, the unborn, or the immigrant among us. As such a prominent nation as the US, we do in a sense set the tone for other nations. Let us be a nation of dignity, honor, and respect.

  5. Joanna says:

    Oh get a grip, I think it’s SO unbelievable that this day in age human beings are actually against using proven and innovative means to further mankind in medicine. How are we ever going to move forward in this world when there are so many BACKWARD thinking people?!

  6. Michael says:

    Let me tell you why there are no medical breakthroughs with embryonic stem cells…. the funding got cut off! That was my joke potion of this letter. Here are the things that have been happening for those of you who think before you speak…….


    While it is true that adult stem cells, which have been studied for more than
    40 years, are farther along in the timeline of developing medical treatments,
    they do not exist for all kinds of tissue, are difficult to isolate, and are often
    not available in the quantities needed for treatment. Human embryonic stem
    cells, which were discovered less than ten years ago, are not bound by the
    limitations of adult stem cells.
    Fortunately, the promising nature of embryonic stem cells, and their
    remarkable ability to become any other type of cell, have allowed rapid
    progress towards promising treatments in animal and laboratory experiments.
    Some examples are listed within.

    • Spinal cord injury and Lou Gehrig’s disease: Scientists are using
    stem cells from a variety of sources to help animals with spinal cord
    injuries regain movement. Human embryonic and adult stem cells have
    been coaxed into becoming types of cells that repair damaged spinal cord
    insulation and replace damaged spinal cord nerve cells in rats. Scientists
    now report that they can use mouse embryonic stem cells to make
    functional motor neurons. Previously paralyzed rats treated with the
    motor neurons were able to move their legs again. This research gives
    scientists insight on how they might one day replace human motor cord
    neurons damaged by spinal cord injuries or diseases such as Lou Gehrig’s
    Disease (ALS) and spinal muscular atrophies. (Annals of Neurology 60(1)
    32–44, laboratory of D. Kerr)

    • Liver disease: Chronic liver diseases such as cirrhosis and hepatitis
    affect 25 million Americans. Although liver transplantation can help some
    of these individuals, there is an extreme shortage of transplantable
    organs. Scientists hope to overcome the organ shortage by using stem
    cells to replace lost liver function. A collaborative team of Japanese and
    NIH-funded scientists coaxed mouse embryonic stem cells into becoming
    liver-like cells. They used the new mouse liver-like cells in a bioartificial
    liver, an implanted device that uses liver cells to replace some liver
    function. Ninety percent of mice with liver failure that were implanted
    with the bioartificial liver survived, while mice with liver failure that did
    not receive the implant all died within two days. If scientists can repeat
    these results with human stem cells, the technique offers promise both to
    individuals born with liver problems and to those who develop liver
    disease later in life. (Nature Biotechnology 24:1412–1419, laboratory of
    I. Fox)

    • Diabetes: One hopeful prospect for treating diabetes is to replace the
    damaged or missing insulin-producing beta islet cells in the pancreas.
    Unfortunately, the supply of transplantable pancreatic islets is unable to
    meet the demand. Scientists have now succeeded in generating insulin secreting cells from hESCs by allowing the cells to mimic pancreatic
    development. These hESC-derived precursor cells have almost as much
    insulin as adult beta cells. If scientists succeed at getting these cells to
    secrete enough insulin in response to blood sugar levels in human
    beings, they may one day be useful for treating diabetes. (Nature
    Biotechnology advanced online publication, laboratory of Novocell Inc.)

    • Restoring vision loss: Retinal pigment epithelium (RPE) cells within the
    eye play a vital role in the survival and maintenance of the rods and
    cones that detect light and color. Death of RPE cells may lead to agerelated
    macular degeneration, a major cause of vision loss in persons
    aged 60 and older. RPE’s have now been derived from human embryonic
    stem cells and may be used to restore vision in those suffering from
    macular degeneration. More recently, these same scientists report that
    they used these cells in rats with a genetic eye disease similar to agerelated
    macular degeneration , a major cause of vision loss in persons
    aged 60 and older. After over a month of treatment with the RPE cells,
    visual acuity in the rats improved. (Cloning and Stem Cells 6:217–245
    and Cloning and Stem Cells 8:189–199, laboratory of R. Lanza)

    • Parkinson’s and Lou Gehrig’s disease: Human embryonic stem cells
    (hESCs) injected into the brains of embryonic mice can take cues from
    the mouse brain environment and differentiated into nerve cells and
    supporting cells typically found in the brain. Mice with functioning human
    nerve cells and supporting cells provide a valuable model system for
    learning how the human brain develops and for testing drugs to treat
    human nervous system diseases such as Lou Gehrig’s and Parkinson’s
    disease. (Proceedings of the National Academy of Sciences of the USA
    102(51):18644–8, laboratory of R. Gage)
    • Spinal cord injury and paralysis: Transplanted stem cells have the
    potential to help repair or replace damaged nerve cells in individuals who
    have suffered a spinal cord injury. NIH-supported scientists injected
    human neural stem cells into the damaged spinal cords of rats. Four
    weeks after the injections, rats treated with human cells regained use of
    their back paws and were able to coordinate steps between their front
    and back paws. Although more tests must be done before this kind of
    stem cell therapy is ready for use in humans, these studies provide hope
    that human stem cells may one day restore mobility to individuals with
    spinal cord injuries. (Proceedings of the National Academy of Sciences of
    the USA 102:14069–14074, laboratory of A.J. Anderson)
    • Hemophilia: Hemophilia is a rare inherited disorder in which the blood
    does not clot normally. Individuals with hemophilia can be treated with
    infusions of blood clotting factors, but these only help for a short time.
    NIH-supported scientists used stem cells to cure mice suffering from a disorder similar to human Hemophilia B. If these results can be repeated in human beings, doctors may one day be able to use
    human embryonic stem cells (hESCs) to restore blood clotting abilities to
    individuals with hemophilia. (Proceedings of the National Academy of
    Sciences of the USA 102:2958–2963, laboratories of O. Smithies and J.

    • Multiple sclerosis: Multiple sclerosis and some other nervous system
    disorders are caused by damage of a protective coating around nerve
    cells called the myelin sheath, which is formed when cells known as
    oligodendrocytes wrap themselves around the axon of the nerve.
    Scientists have formed oligodendrocytes from human embryonic stem
    cells and used them to restore the myelin sheath in mice. If this work
    can be repeated in humans, it may enable scientists to help individuals
    with nervous system disorders recover some of their mobility and
    sensations. (Glia 49:385–396, laboratory of H.S. Keirstead)
    • Lou Gehrig’s Disease and spinal cord injury: Individuals who suffer
    spinal cord or motor neuron diseases such as Lou Gehrig’s disease
    (amyotrophic lateral sclerosis or ALS), currently have no treatment
    option available to reverse their condition. NIH-funded scientists have
    directed human embryonic stem cells into cells that express markers and
    transmit nerve impulses in a manner similar to motor neurons. If they
    are able to function in human beings after transplantation, these cells
    may also serve as a renewable source of replacement motor neurons to
    treat spinal cord injury and motor neuron diseases. (Nature
    Biotechnology 23:215–221, laboratory of S-C. Zhang)
    • Heart Disease: Mice with severe heart defects appeared to return to
    normal heart function following injections of embryonic stem cells.
    (Science 306:247–252, laboratory of R. Benezra) In addition, heart
    muscle cells derived from human embryonic stem cells were also able to
    restore heart rhythm in 11 out of 13 pigs whose biological pacemaker
    had been damaged. If this work can be repeated in human beings,
    scientists may be able to use these cells to replace human heart
    pacemakers rather than the current implanted electronic devices. (Nat
    Biotech 22:1282–1289, laboratory of L. Gepstein) • Parkinson’s Disease: In 2002, scientists reported that they had
    successfully derived dopaminergic neurons from mouse embryonic stem
    cells. (Nature 418:50–56, 2002, laboratory of R. McKay) When grafted
    into rat models of Parkinson’s disease, the cells were able to improve
    motor function. More recent work has produced human dopamine
    producing cells from human embryonic stem cells, which may be used to
    treat humans with Parkinson’s disease. (PNAS 101:12543–8, laboratory
    of L. Studer)


    • Infertility treatment: Scientists report production of functional sperm
    in mice from human embryonic stem cells, which may be used to treat
    men who are suffering from sterility or infertility. (Nature 427:148–154,
    laboratory of G.Q. Daley) In addition, oocytes (eggs) have been
    generated from embryonic stem cells. This has important implications
    for: creation of new hESC lines, generation of tissue for transplantation,
    generation of human oocytes, and infertility treatment. (Science
    300:1251–1256, 2003, laboratory of H.R. Schöler)
    • Lou Gehrig’s Disease and Spinal Cord Injury: Using pluripotent cells
    derived from human embryonic germ cells, scientists have been able to
    partially restore paralyzed rats’ ability to move. The rats serve as an
    animal model of amyotrophic lateral sclerosis (ALS), also known as Lou
    Gehrig’s disease. This work provides hope that scientists may one day be
    able to use embryonic stem cells to restore movement to patients
    suffering from Lou Gehrig’s disease. (J Neurosci 23:5131–5140, 2003,
    laboratories of J.D. Gearhart and J.D. Rothstein)

    • Diabetes: scientists at Stanford University recently reported that they
    could use mouse embryonic stem cells to “cure” a mouse model of
    diabetes. Their results suggest that embryonic stem cells could serve as
    a source of insulin-producing replacement tissue and provide hope that
    this technique, adapted to human embryonic stem cells, may lead to a
    cure for human diabetes patients. (PNAS USA 99:16105–16110, 2002,
    laboratory of S.K. Kim)
    Information source: http://stemcells.nih.gov

  7. Michael says:

    As soon as one of these cures becomes available and you are on your death bed with the disease it cures and it’s do or die, you are soooooooooo going to go the stem cell route.

  8. Matthew says:

    Nice attempt at an argument citing the use of animal embryonic stem cells. human embryonic stem cells still have shown minimal success and potential and are a mere shadow of the effectiveness of adult cells. politics should be cast aside, and money should be invested where there’s a demonstrable return.

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