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In First, FDA Approves Autism Stem Cell Trial


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A new clinical trial is set to examine whether or not stem cells from a child’s own cord blood are an effective treatment for autism symptoms.

The study, which was announced Tuesday, is the first of its kind to win approval from the U.S. Food and Drug Administration.

Researchers said they plan to include 30 kids with autism ages 2 to 7. Each participant will receive two injections — one a placebo and the other containing stem cells from the child’s own cord blood — over the course of the 13-month trial. In an effort to limit bias, both the study participants and the lead investigators will not be told which injection is given at what time.

Scientists are looking to assess whether or not the stem cell infusion leads to improvements in behavior or language in children without any known cause for their autism diagnosis such as a genetic conditions like fragile X syndrome.

“Cord blood stem cells may offer ways to modulate or repair the immune systems of these patients which would also improve language and some behavior in children who have no obvious reason to have become autistic,” said Michael Chez, director of pediatric neurology with the Sutter Neuroscience Institute in Sacramento, Calif. and the study’s principal investigator.

Researchers have looked to stem cells to address numerous conditions in recent years ranging from cerebral palsy to cancer, given the cells’ unique ability to take on the characteristics of other types of cells or grow into tissue.

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Comments (11 Responses)

  1. Patricia Elaine Chandler says:

    “no obvious cause to become autistic”??? This is wrong! I was Born Autistic. Autism is Natural. DRUGS are NOT Natural.

    The Parents of these Clinical Trial Subjects are being Paid to sacrifice their Children; they have been lied to.

    This is going to be a Double-Blind Study but the Site Monitors/Coordinators Will KNOW Who, which Subject is on DRUG.

    Where in GODs Name are the Human Rights of the Child being Experimented on?

    They Now ABORT ALL HUMAN BEINGS WITH DOWN SYNDROME through prenatal screenings, after Successful PAST CLINICAL TRIALS.

    AUTISM IS NEXT. And therefore I Don’t Really Exist.

    So, can I Stop Paying Taxes Now? I think ALL HUMAN BEINGS who currently are Down Syndromed in their personality should be Exempt from ALL MANDATORY HUMAN ACTIVITIES. I mean, they No Longer Even Exist!

  2. Erica says:

    Maybe one day there will be a stem cell trial for depression, Brian damage due to abuse, and learning disabilities.

  3. Erica says:

    Sorry, ‘brain’ auto correct.

  4. David Granovsky says:

    Shall we consider adult stem cells for Autism? Let’s look at the history of safety and efficacy: Used for over 40 years successfully in bone marrow transplants. Used successfully for years in PRP treatments. Thousands of successful adult stem cell trials and studies and thousands of patients treated successfully around the world. Blood, hearts, tracheae and other organs created with adult stem cells…all of this was done with zero to virtually no adverse affects and no controversy…and there are many, many autistic spectrum patients who have ALREADY derived significant benefit from stem cell treatments. If you would like more details, please ask.

  5. tg says:

    These kids are not being given drugs. These are their own stem cells from their umbillical (sp) cord. There’s not drugs. I know this is opening a can of worms, but some people are born with autism. Others like our child was not.

  6. Linda says:

    Those people with autism who can speak up for themselves do not have the same autism my daughter has – she has been unable to speak until just recently, even that is very difficult to understand – she had severe gut issues that we are finally getting healed – she used to slap herself hard on the face about 100 times per hour – she deserves some relief from this autism. Those who are happy with how they feel and their place in the world do not need this help, but kids like mine who are ill and feel bad every day should be offered help. I don’t think an adult who is functioning and happy should speak for my child who has suffered greatly most of her 14 years. Stem cell therapy is being done in other parts of the world with great success, I don’t understand why the US is so opposed to testing a treatment that has proven successful with no negative effects in other parts of the world. Why not test what is already reportedly working?

  7. Victoria says:

    Patricia, being that you claim to have autism and have the ability to respond and communicate on an online post but have absolutely no understanding of the grave deficits most autistic children and their families struggle with, I highly recommend that you volunteer or get involved in a program, school, or institution that assists autistic children and their families. Perhaps then you might understand how devastating this illness is to the majority of children and their families who cope with it. Moreover, you ought to study science and genetics a bit more to understand that there is no such thing as a genetic epidemic…so your “god given” euphimism doesn’t really apply here unless you are of the belief that no illness or malady should be prevented or addressed by medicine, including viruses, cancers, broken bones, crooked teeth, polio, diabetes, etc. And yes, I did say ‘ilness.’ You may be the 1/10,000 children ‘born’ with autism that Kanner described in the last century, though it is practically impossible since he described those individuals of incapable of communication and recovery and you appear to have done both. Nonetheless, our kids today diagnosed with autism have many affects not described by Kanner and do not fit his diagnosis- creating much confusion about what “autism” is and what these individuals are capable of. I have 2 young children diagnosed with severe autism. My daughter, 8, like you, is now recovered and can communicate and write and appears completely reversed. However, unlike you, because she lives with our son who is still struggling with some severe autistic-like challenges, she would never dare to suggest that he ought to just suffer his lot without any intervention. She knows how devastating this is for all of us and how much better it and happier our lives would be if our son recovers or improves. Autism is no walk in the park. The good news is that, as my daughter has shown, recovery does exist and is possible. Improvement is possible. In my son’s case he is responding to medications that are treating his condition as an auto-immune disorder. It seems to be working. I hope more research will investigate this condition as a medical issue, very likely an immune disorder. It is imperative that we stop the love-fest with genetics and start looking for the real culprit.

  8. Bob_in_NYC says:

    I’m not sure that this particular study will produce anything since it appears flawed. If cord stem cells are to be used then they would need to be collected at birth. And since autism generally is not diagnosed until at least 2 years and the prevalence is about 1%, it looks like there will need to be a high number of collections done. Especially if one takes into account that the participation rate in the study is probably not going to be too high.

  9. AlliciaCueva says:

    If somebody knows, please tell wich kind of stem cells, and their specific function in this case.

  10. Terri Applegate says:

    Why would you only include such young ages? My son is Developmentally Disabled and we have been waiting for this clinical study in the US for years. What is your advise . Please consider older patients willing to do trials.
    Thank you for your time,
    Desperate Mother and Father

  11. anny says:

    I was searching all over the place for possible cure of Learning Disabilities. I have a 7 year old son. He is cute, intelligent, and very active. However, I was told, although inconclusive, he seems to have a bit of difficulty in pronouncing words n difficulty understanding. Sometimes, he does it beautifully, sometimes he just doesn’t. However, he cannot speak full sentence consistently, even though, he gets along well with other kid. He speaks full sentence with them, but they sometimes don’t understand him. He is extremely happy and popular, so I am just puzzle, does he really have LD? or is he just a late boomer. Both myself and my wife always take him out, so he can explore in Disneyland , and other theme parks, and vacations in Asia. He loves it, and we provide him with many great TV series, like “Thomas and Friends”, “Mickeys”, and “Barney series” to stimulate his interest in learning. He loves watching those series, and can imitate characters, so I hope teachers are wrong. My son goes to a very well known international schools, and we hope that he can continue normally like other kids. However, if he really has LD, and its no cure, will stem therapy restores him to normal. Has anybody try, and can somebody please let me know if they have success with it… I am just dead worried, but don’t have a clue of what I can do… Appreciate of any constructive comments. Thank you….

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