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FDA approves second human embryonic stem cell trial
November 22nd, 2010
07:15 PM ET

FDA approves second human embryonic stem cell trial

For only the second time in history, the Food and Drug Administration has approved human trial of a therapy developed from embryonic stem cells.

William Caldwell, CEO of Massachusetts-based Advanced Cell Technology (ACT), tells CNN that 366 days after filing the application, the FDA granted approval for his company to start a clinical trial using cells grown from human embryonic stem cells.  The treatment will be for an inherited degenerative eye disease.

"Were still absorbing the fact that we finally got the approval" says Caldwell.  "The real work lies ahead."  Getting the trial going is the next big step, says Caldwell.  He hopes the first patients can be enrolled by the first quarter of the next year.

In July the FDA gave the Geron Corporation the final go-ahead for its study, which led to the first human being injected with cells derived from human embryonic stems last month. In that study a newly paralyzed patient had a stem cell treatment directly injected into the spinal cord. While the immediate goal is to test the safety of these cells, the ultimate goal in Geron's trial is to permanently repair damage cause by a spinal cord injury.

When ACT's clinical trial gets under way, it,too, will first test the safety of the cells they're injecting.  The company is hoping to find a cure for Stargardt Macular Dystrophy, the most common form of juvenile macular degeneration, for which there is currently no cure.  It affects about 1 in 10,000 children. People with this disease usually start losing their sight between the ages of 8 to 10 years and can be legally blind by the time they reach their 30s says Caldwell.

Embryonic stem cells are only four to five days old and have the ability to turn into any cell in the body.  But the cells patients will receive in both of these clinical trials aren't pure human embryonic stem cells.  Geron has coaxed its cells into becoming a type of cell that insulates nerve cells.  ACT's stem cells have been turned into healthy retinal pigment epithelium (RPE) cells.   RPE cells are naturally found behind the neural retina and it's the death of these cells that leads to blindness in patients with macular degeneration.  The company says their animal studies found vision restored after these new RPE cells were injected.

If this treatment works, Caldwell believes it could be applied to other diseases that lead to blindness, including age-related macular degeneration, which affects millions of Americans and will only increase as baby boomers continue to get older.

ACT's  method of removing stem cells from an embryo is different from Geron's. ACT developed a method in which only one stem cell is removed from an embryo, similar to a method  used in some fertility clinics to test an embryo for genetic abnormalities.  That stem cell is then used to grow many more stem cells.  By removing only one stem cell, the embryo is not destroyed. Destruction of embryos  is the main reason that embryonic stem cell research has been so controversial.


soundoff (169 Responses)
  1. Jordan

    Maybe now medical science can create some lasting cures for diseases and maladies that we currently have no cure for. More power to them.

    November 23, 2010 at 12:21 | Report abuse | Reply
  2. cjg85

    In an effort to prevent future postings by religious militants, allow me criticize their fanatical beliefs. I am a combined M.D./Ph.D. (in bioethics) student, thus, I will set up a scenario for all of the people who are dragging this country back into the 16th century. We all know stem cells are not used to ‘justify’ abortion; the claim is nonsense and is something my 15 year old brother could refute. However, let us imagine that you are right: there is a ubiquitous, evil conspiracy set out to abort young babies in an attempt to cure the masses. Astonishing, evil, deplorable…correct? Now, let us consider your belief/definition of God. God is all-knowing and all-powerful; a perfect, transcendent being. Now, if stem cell research is “evil”, than why does your God allow it? I’m sure one would say: “Well, it is because God endowed humans with free-will!” With that said, if God did endow our species with free will—God must have known the consequences of giving us free will; because God is all-knowing. Therefore, if God endowed our species with free will knowing the disastrous consequences…God is not much of a God now is he/she/it? Furthermore, if God employed abortion/stem cell research as modalities of testing one’s faith and morality (a divine obstacle course, if you will); that would not make God much of a God either, would it? If I were to tell you that I was going to hit your father with my car (seriously injuring him), simply because I thought you needed to be tested spiritually, you would think I was the most wicked human being on earth! But somehow, the aforementioned logic is acceptable for one’s God? Lastly, God cannot make something “right” or “wrong” just by saying so. If God were to descend down into the masses and say: “Killing is right”, you would say “no, it is not!”…Why? It is because you have an ingrown sense of morality! God has nothing to do with it. God is a protective mechanism...an ideology that should be abandoned! I understand that it is very difficult for one to abandon the cognitive crutch (called “God”), because it means that one has to admit that he/she is alone in the universe, and that no one else cares. It is time for our species to worry about what happens on this earth, not in/on an imagined one. Abortion is not evil, do you have any idea how many babies would end up in dumpsters or garbage bags if abortion was illegal? Infanticide occurs across all species, it is not an individual evil of the human species. But, “It’s a baby!”, do you remember when you were in the womb, further, do you have any idea how many times a women spontaneously aborts/miscarriages throughout her lifetime? Perhaps we should outlaw women becoming pregnant altogether? Do you truly want to know what happens to you after you die religious maniacs? I have the answer: the same as before you were born…nothing! You were already dead for millions of years! Stem cell research is a promising (NOT CONTROVERSIAL) treatment modality that can eventually be employed to cure thousands of diseases. Let’s see how much opposition you have against its use when/if you or your child ever develop a crippling disorder.

    November 23, 2010 at 13:48 | Report abuse | Reply
    • CC

      I am an MD/PhD student as well (neuroscience). I believe in God, do not believe in everything in the bible (written by MEN) and believe in many Buddhist principles. I dont get your argument that God does not exist. Perhaps He does exist just not exactly as we know. You of all people should be open minded to what we do not know, that doesnt mean to be ignorant and believe everything, nor does it mean that you should refute everything because nothing is provable.

      At the end of the day, NOTHING is 100% provable nor fully understood, not even widely accepted laws (gravity), yet we can still believe that they are likely real.

      May 20, 2012 at 22:36 | Report abuse |
  3. - -

    This is not science versus religion. It is ignorant to generalize religion, and specifically Christianity, by assuming such.

    Personally, I view science as a way of understanding how God works. Science is not fictional, just as I believe God is not fictional.

    Also, just because someone may not believe in a god or religion does not mean they cannot be confused with ethical issues.

    I am only addressing the fact that it is unnecessary to include religion in this discussion when no harm is being done to the embryo. It's like donating skin, or a lung, or a kidney or any organ. The embryo is just donating a cell. There is no need to get into an ignorant debate about the nonexistent "rivalry" between science and religion. It really comes down to ethics. Nothing is being harmed, so there should not be an issue.

    November 23, 2010 at 16:43 | Report abuse | Reply
  4. cjg85

    –My above post/response is based on the religious fallacies posted above…again, reading is key! I agree, it is not a science vs. religion debate (religion, in no way, shape, or form can debate science). I was simply responding to the religious/fanatic responses found above. In no way was the response ignorant, it is, however, ignorant to categorize a response as such by not fully understanding its context. The aforementioned article had been categorized as a religious article, so I simply countered with a scientific response. Again, religious believers read 1-2 words and attack (typical). As for: “Personally, I view science as a way of understanding how God works”—sure, if one’s understanding of science is at an elementary level. However, science is (and always will be) proof against God and religion. If your premise was based on the notion of intelligent design…allow me to quickly negate ID. The human body is in fact poorly designed, a bird’s respiratory/cardiovascular system is highly superior to man. Believers in ID once held faith in the complex proteins of a flagellum, believing that such proteins were constructed intelligently to give function to the rotation of the flagellum’s tail…that is, until the proteins were found to serve an individualized function in other organisms. Moreover, I won’t even begin to start with catastrophic geology or creationism. Science is not a tool to understand God, science is a tool used to improve the lives of others; science is needed because religion is not enough (because it is the oldest fallacy alive). The church has gone back on its word thousands of times in order to conform to science’s truths. The bible and God is the creation of man…why does a God exemplify trivial human emotions such as jealousy, hatred, envy, etc. It is because God was constructed by man. Why would a man pray to a God who is so human-like? A true God would not need praise or belief. Anyway, keep sitting on your couch believing that your imagined savior will one day save humanity. I’ll keep going to class and studying 80 hours/week so that I can actually make a difference in the lives of thousands of people. In your prayers tonight, make sure that you tell your God that he is doing a horrible job.

    November 23, 2010 at 18:00 | Report abuse | Reply
    • Jerry

      Bravo!

      November 23, 2010 at 18:52 | Report abuse |
    • - -

      cjg85- I wasn't really commenting specifically to you, mostly because I barely even glanced at your comment. It is good to argue and I am not saying anything you said about the world not being perfect isn't true, but it does seem like you are a bit fanatical in trying to prove religion false. Religious fanatics aren't the only fanatics. Birds probably have a better cardiovascular/respiratory system because most of them spend much of their life flying, which is aerobic exercise. If we spent a majority of our time running or swimming or doing some sort of aerobic exercise, we would probably have a better cardiovascular/respiratory system too. We would probably start to evolve in that direction.
      You are assuming too much about me and what I believe.

      November 29, 2010 at 17:35 | Report abuse |
  5. cjg85

    Again, you must believe me when I tell you that your understanding of science is at best elementary. Evolution did not and will never conform to the needs of individual species; hence: extinction. As for your comment: "but it does seem like you are a bit fanatical in trying to prove religion false. Religious fanatics aren't the only fanatics". You must be careful in your word usage; fanatic implies that one has zeal when applying uncritical (that is, unanalyzed/uneducated) beliefs. Case in point: my dictation found above. Moreover, you are absolutely right, I most likely am "assuming too much about you and what you believe". However, stereotyping is fast and easy. But, since you are an aficionado when it comes to evolution; I don’t have to tell you that stereotyping involves little energy expenditure and is useful when it comes to one’s individual fitness. Additionally, religious fanatics are the only true fanatics: your arguments are illogical, and your beliefs cause pain and suffering. Lastly, religious fanatics are often uneducated and end up looking less than intelligible when posting comments somewhere they have no business expressing their opinion. We don’t come into your churches, therefore, stay out of our scientific advances. Cheers.

    November 30, 2010 at 21:40 | Report abuse | Reply
    • - -

      You may like to read the first chapter of this book.

      http://www.nap.edu/openbook.php?record_id=11876&page=1

      January 29, 2011 at 16:14 | Report abuse |
  6. Caligirl

    I'm both a political scientist and a Christian, and my boyfriend is in the medical field...so I can say I truly understand all sides of this argument; but this comment is not coming from the political or religious sides of me, but rather from the sister in me...a sister who's 29 year old brother has suffered with Stargardts Macular Dystrophy for the pass 11 years of his life. My brother was diagnosed with Stargardts when he was 18, during his senior year in High School. He was one of those just amazing kids. He was my younger brother, but I looked up to HIM in so many ways...he was a star athlete in football and lacrosse, and was in enrolled in Gifted and Talented programs and Honor courses all his life. He was the definition of over-achiever! In some ways I was jealous...but mostly I was just proud of him. Then in the Fall of 1999, during football practice he began to complain to his coach that he was experiencing blind spots in his vision, and he wasn't able to see the ball being passed to him. Coach pulled him out of practice and told him to "get it check-out." That week he went to our local Optometrist...then to a specialist at John's Hopkins in Baltimore. What started out to be, what we thought a simple eye infection, turned out to be a dieses that would come to change not only his life, but ALL of our lives. I still remember the pain in my mom's voice, as she told me over the phone that the doctors discovered the dieses and my brother was going to go blind. My first reaction was well, what surgery does he have to do? ...I was totally ignorant to what we were dealing with, but soon found out through non-stop research over the next year that....there is NO cure, NO surgical procedure, and basically NO hope....UNTILL NOW!!!! My brother, my family, and I have stood by year after year for the passed decade watching this disese slowly deteriorate his eye-site...and worst of all, his will and dreams for a future. First he had to stop playing sports his last year in high school, he then struggled through University because it was becoming harder to read the teacher's notes on the blackboard/projector..then he couldn't read the small print in text books, only with a magnifier, and even still with that he would quickly get headaches from straining his eyes. Even with all these issue he never wanted to ask for help, he was too proud. I would see him struggle so hard to read, but when I would ask him if I could read the book for him, he would always pretend everything was fine, and acted as if he didn't need my help. My brother is tough like that...a go-getter, always proud and strong. But not even that lasted long...and the day soon came when he HAD to start asking for help. In 2004, with the grace of God and my brother’s determination and hard work he graduated University, but that same year his eye-sight got so bad he no longer was able to drive his car. Now, I don't know if you guys can understand the magnitude of telling a 23 year old boy he can no longer drive!! It was devastating, and it was in that moment that his pride was out the window, and he HAD to start asking for help, wheter he wanted to or not. "Sis," he would say in a sad voice...."I hate to ask you this, but can you take me to the mall, I need to buy a few things" or "Sis, can you drop me off at my friend's house, the boys are having poker night...and do you mind if you stay to help read off the cards for me?..I can't see the table/cards very well" ....Now, you all don't know my brother, but I do...and I know how hard it is for him to ask these favors of me, or of anyone for that matter. This is the same guy who was the a star athlete, Vice President of his Fraternity, good looking kid...girls loved him and so did his guy friends...the same guy that has the BIGGEST heart, and someone who was always helping others...now HE was the one who had to ask for help, it destroyed him. But, through it all, when I would brake-down and cry after his annual vision examines, and we would discover his vision had worsened since the year before...HE would be the one telling me..."sis, don't worry about me...someday there will be a cure, a HOPE, I know it!" Well, hopefully that day has come...whether ACT (Advanced Cell Technology) can truly find a cure to Stargardt and other forms of Macular Dystrophy, at least it has giving him, my family, thousands...and soon millions of others hope. I can't thank ACT and there medical team enough for even shedding attention to this rare disease, and pray that this is the breakthrough we have been waiting for; and when I say "we" this includes ALL human kind...this benefits ALL of us!!! ...and for anyone who feels a need to criticize...before you do, think about how you would feel if one of your loved ones had a dieses that there is NO cures for, and then one day someone gives you hope...what would you do? ...how would you feel? This morning as I was talking to my brother about him hopefully being recruited for the clinical trials, he hugged me and said, "One day, sis, I'm going to throw the ball around with my future kids, and I'm going to take a long drive up the PCH (Pacific Coastal Highway) with Crystal (that's his girlfriend) ...and, I'm going to be the one behind the steering wheel" ...Well, I hope so, bro...I pray that day is closer than we could have ever imagined!!! Jeremiah 29:11 – "For I know the plans I have for you,” declares the LORD, “plans to prosper you and not to harm you, plans to give you hope and a future."

    December 20, 2010 at 20:16 | Report abuse | Reply
  7. Caligirl

    just realized the my auto correct misspelled disease, and wrote "dieses" ...sorry if it was confusing.

    December 20, 2010 at 20:32 | Report abuse | Reply
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